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"21130-777-71", "21130-777-82", "42571-433-45", "0363-4400-19", "0363-4400-84", "0363-4400-32", "63981-194-96", "63981-194-85", "63981-194-01", "63981-194-05", "41163-313-65", "41163-313-72", "72657-112-90", "72657-112-20", "72657-113-88", "72657-113-20", "72657-132-01", "42507-141-65", "42507-141-72", "42507-141-90", "42507-141-75", "63941-009-09", "70756-051-11", "70756-051-12", "70756-052-11", "70756-052-12", "59651-701-50", "70000-0654-1", "55910-194-02", "55910-194-39", "55910-194-71", "55910-194-51", "55910-194-82", "55910-194-78", "62135-807-90", "62135-808-90", "72288-151-75", "41520-901-72", "41520-901-65", "56062-194-71", "56062-194-02", "63941-011-53", "25021-755-05", "25021-756-10", "25021-756-50", "68382-444-05", "69168-443-32", "69168-443-52", "69168-443-09", "69168-443-50", "69168-443-99", "0904-5780-51", "0904-5780-17" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEGA 3", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "002", "drugseparatedosagenumb": "1", "drugdosagetext": "1 GRAM", "drugdosageform": "Capsule", "activesubstance": { "activesubstancename": "CAPSAICIN" } }, { "drugcharacterization": "2", "medicinalproduct": "MOUNJARO", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "drugdosageform": "Injection", "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "openfda": { "application_number": [ "NDA215866" ], "brand_name": [ "MOUNJARO", "MOUNJARO KWIKPEN" ], "generic_name": [ "TIRZEPATIDE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-3002", "0002-1506", "0002-1495", "0002-1484", "0002-1471", "0002-1460", "0002-1457", "0002-1152", "0002-1243", "0002-2214", "0002-2340", "0002-2423", "0002-4052", "0002-4103", "0002-4210", "0002-4304", "0002-4523", "0002-4612", "0002-3466", "0002-3455", "0002-3444", "0002-3433", "0002-3422", "0002-3411" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "TIRZEPATIDE" ], "rxcui": [ "2601743", "2601746", "2601755", "2601758", "2601761", "2601764", "2601767", "2601770", "2601773", "2601776", "2601784", "2601785", "2644396", "2644399", "2644401", "2644403", "2644405", "2644407", "2644409", "2644411", "2644413", "2644415", "2644417", "2644419", "2732437", "2732442", "2732446", "2732449", "2732452", "2732456", "2733666", "2733668", "2733670", "2733671", "2733673", "2733675", "2734623", "2734628", "2734632", "2734636", "2734640", "2734644", "2735286", "2735288", "2735290", "2735292", "2735294", "2735297" ], "spl_id": [ "08af2d71-07e5-474b-98a2-eb5be9bcf894" ], "spl_set_id": [ "d2d7da5d-ad07-4228-955f-cf7e355c8cc0" ], "package_ndc": [ "0002-1506-01", "0002-1506-80", "0002-1506-61", "0002-1495-01", "0002-1495-80", "0002-1484-01", "0002-1484-80", "0002-1471-01", "0002-1471-80", "0002-1460-01", "0002-1460-80", "0002-1457-01", "0002-1457-80", "0002-1152-01", "0002-1243-01", "0002-2214-01", "0002-2340-01", "0002-2423-01", "0002-3002-01", "0002-4052-01", "0002-4052-11", "0002-4103-01", "0002-4103-11", "0002-4210-01", "0002-4210-11", "0002-4304-01", "0002-4304-11", "0002-4523-01", "0002-4523-11", "0002-4612-01", "0002-4612-11", "0002-3466-01", "0002-3466-11", "0002-3455-01", "0002-3455-11", "0002-3444-01", "0002-3444-11", "0002-3433-01", "0002-3433-11", "0002-3422-01", "0002-3422-11", "0002-3411-01", "0002-3411-11" ], "nui": [ "N0000194015", "N0000000152", "N0000178480", "N0000020058" ], "pharm_class_epc": [ "Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]", "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_moa": [ "G-Protein-linked Receptor Interactions [MoA]", "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "OYN3CCI6QE" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IRON", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "drugdosageform": "Tablet", "activesubstance": { "activesubstancename": "IRON" }, "openfda": { "brand_name": [ "FERRUM METALLICUM 6X", "FERRUM METALLICUM", "REAL SUMMER" ], "generic_name": [ "IRON" ], "manufacturer_name": [ "True Botanica, LLC", "Boiron", "KAYONE" ], "product_ndc": [ "53645-1472", "0220-2055", "0220-2085", "69449-1010", "0220-2051", "0220-2050", "0220-2047", "0220-2046", "0220-2054" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL", "TOPICAL" ], "substance_name": [ "IRON" ], "spl_id": [ "23927d2e-da68-f2b5-e063-6394a90a3b8a", "0a0ce402-1803-62f2-e063-6294a90a9770", "0a0ce624-1a00-85f4-e063-6294a90ac29a", "28d3becf-e4b9-4bcf-e063-6294a90a1327", "f6002c71-2a53-b17b-e053-2995a90a0576", "0a0ce624-19fe-85f4-e063-6294a90ac29a", "0a0cdff5-2760-8938-e063-6294a90ad4fb", "0a0ce402-1802-62f2-e063-6294a90a9770", "f5294c54-6706-bc8d-e053-2a95a90a5567" ], "spl_set_id": [ "2392929c-996b-01e0-e063-6394a90aa2b9", "8591b12c-51c8-9839-e053-2a91aa0aa937", "87372ec7-eacf-90b1-e053-2a91aa0afadf", "63021d49-8720-4e4e-a08f-a5d2f6acfaa5", "859195ed-0b6c-f4fe-e053-2991aa0ad85b", "85917340-1f94-08db-e053-2a91aa0a77c9", "85914cb4-f903-80c6-e053-2a91aa0ae14a", "85912948-19cc-76be-e053-2991aa0a3e5a", "85919b82-39cf-254d-e053-2a91aa0a6150" ], "package_ndc": [ "53645-1472-6", "0220-2055-41", "0220-2085-41", "69449-1010-1", "0220-2051-41", "0220-2050-41", "0220-2047-41", "0220-2046-41", "0220-2054-41" ], "unii": [ "E1UOL152H7" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RYBELSUS", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugdosagetext": "3 MILLIGRAM", "drugdosageform": "Tablet", "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "openfda": { "application_number": [ "NDA213051" ], "brand_name": [ "RYBELSUS" ], "generic_name": [ "ORAL SEMAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk Pharmaceutical Industries, LP" ], "product_ndc": [ "0169-4303", "0169-1715", "0169-1704", "0169-1709", "0169-4307", "0169-4314", "0169-4815", "0169-4804", "0169-4809" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SEMAGLUTIDE" ], "rxcui": [ "2200644", "2200650", "2200652", "2200654", "2200656", "2200658", "2707547", "2707549", "2707551", "2707553", "2707555", "2707557", "2736944", "2736946", "2736948" ], "spl_id": [ "5176eed4-f8f8-4f88-a079-11f16864f40a" ], "spl_set_id": [ "27f15fac-7d98-4114-a2ec-92494a91da98" ], "package_ndc": [ "0169-1715-30", "0169-1715-90", "0169-1704-30", "0169-1709-30", "0169-4303-01", "0169-4303-13", "0169-4303-90", "0169-4303-93", "0169-4303-30", "0169-4303-99", "0169-4307-01", "0169-4307-13", "0169-4307-30", "0169-4314-01", "0169-4314-13", "0169-4314-30", "0169-4815-30", "0169-4815-90", "0169-4804-30", "0169-4809-30" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "53AXN4NNHX" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20250124" } } }, { "safetyreportversion": "2", "safetyreportid": "12444539", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20220720", "reporttype": "1", "serious": "2", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20160607", "receiptdateformat": "102", "receiptdate": "20220607", "fulfillexpeditecriteria": "2", "companynumb": "US-PERRIGO-15US012153", "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "68", "patientonsetageunit": "801", "patientweight": "68.934", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Therapeutic product effect decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Product administered at inappropriate site", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MINOXIDIL", "drugbatchnumb": "5EV0848", "drugauthorizationnumb": "091344", "drugdosagetext": "UNKNOWN, UNKNOWN", "drugdosageform": "Cutaneous foam", "drugadministrationroute": "061", "drugindication": "Alopecia", "drugstartdateformat": "610", "drugstartdate": "201511", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "MINOXIDIL" }, "openfda": { "application_number": [ "M032", "ANDA209074", "ANDA091344", "ANDA078176", "ANDA075357", "505G(a)(3)", "ANDA218616", "ANDA076239", "ANDA075598", "NDA019501", "ANDA072709", "ANDA208092", "NDA021812", "ANDA075518", "NDA020834", "ANDA075438", "ANDA071826", "ANDA071839", "ANDA074588", "ANDA071344", "ANDA071345" ], "brand_name": [ "MELAO HAIR GROWTH MOUSSE", "MINOXIDIL", "5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN", "OLIVITA MINOXIDIL", "HAIR REGROWTH TREATMENT", "MINOXIDIL (FOR MEN)", "FOLIGAIN PROFESSIONAL SERIES EXTRA STRENGTH FOR WOMEN MINOXIDIL TOPICAL HAIR REGROWTH TREATMENT", "HIMS HAIR REGROWTH TREATMENT", "HAIR REGEN HAIR GROWTH TREATMENT", "SANTO REMEDIO MENS HAIR REGROWTH TREATMENT MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH UNSCENTED", "TACRUITF 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "GEMACHLICH ZUHAUSE BEARD GROWTH TREATMENT SERUM", "ELEVATE HAIR GROWTH SERUM", "AGIKENB 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "REGOXIDINE (FOR WOMEN)", "OPUSMEDS EXTRA STRENGTH MINOXIDIL", "HAIR LEAVE IN", "5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN", "5%MINOXIDIL TOPICAL FOAM", "MINOXIDIL 5% (FOR MEN)", "MEMBERS MARK HAIR REGROWTH TREATMENT", "ELEVATE HAIR REGROWTH TREATMENT 5", "BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM", "MINOXIDIL HAIR REGROWTH TREATMENT", "BASIC CARE HAIR REGROWTH TREATMENT", "FOLIGAIN PROFESSIONAL SERIES EXTRA STRENGTH FOR MEN MINOXIDIL HAIR REGROWTH TREATMENT", "MINOXIDIL EXTRA STRENGTH FOR MEN", "BOSLEY WOMAN 2 MINOXIDIL TOPICAL SOLUTION", "STAFENIT HAIR REGROWTH TREATMENT TOPICAL MINOXIDIL", "REGENPURE PRECISION", "HAIR GROWTH FOAM", "5% MINOXIDIL HAIR GROWTH TOPICAL SOLUTION", "MINOXIDIL FOR WOMEN", "ERWCNMIE 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "VERDIBLISS 5% MINOXIDIL TOPICAL HAIR REGROWTH TREATMENT FOR MEN", "MENS JIVEXA EXTRA STRENGTH MINOXIDIL", "GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL", "WOMENS ROGAINE UNSCENTED", "DAVV MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT", "AROMATICA HAIR ACONDICIONADOR ROMERO CON MINOXIDIL", "NIZORAL HAIR REGROWTH TREATMENT FOR MEN", "HAIR ACONDICIONADOR", "AROMATICA HAIR TRATAMIENTO ROMERO CON MINOXIDIL", "5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "TOMUM HAIR GROWTH TREATMENT FOR MEN MINOXIDIL UNSCENTED", "GOOD SENSE HAIR REGROWTH TREATMENT", "BOSLEY MAN 5 MINOXIDIL TOPICAL SOLUTION", "KERANIQUE 2% HAIR REGROWTH TREATMENT FOR WOMEN", "TAGOQHIA 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "5% MINOXIDIL HAIR REGROWTH TREATMENT", "5% MINOXIDIL(FOR MEN)", "NUVARRA MENS MINOXIDIL HAIR REGROWTH TREATMENT", "HERS HAIR REGROWTH TREATMENT", "KIRKLAND SIGNATURE MINOXIDIL", "MINOXIDIL (FOR WOMEN)", "5%MINOXIDIL HAIR GROWTH SPRAYS SERUM", "5% MINOXIDIL WITH BIOTIN", "BOSLEY MINOXIDIL TOPICAL SOLUTION 2 FOR WOMEN", "MINOXIDIL HAIR GROWTH SERUM", "SANTO REMEDIO WOMENS HAIR REGROWTH TREATMENT MINOXIDIL UNSCENTED", "ETADERM MENS MINOXIDIL HAIR REGROWTH TREATMENT EXTRA STRENGTH", "TNEGHC 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "BEHATMH 5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN", "MINOXIDIL 5 PERCENT (FOR WOMEN)", "REGENIVADE HAIR GROWTH FOAM", "HAIR GROWTH SOLUTION", "CLEVARIEL MINOXIDIL HAIR GROWTH SERUM", "EQUATE HAIR REGROWTH TREATMENT", "THE ROOT OF GOODNESS HEALTHY GROWTH HAIR REGROWTH SYSTEM FOR WOMEN 3 STEP SYSTEM", "5%MINOXIDIL TOPICAL AEROSOL(FOR MEN)", "HAIR CHAMPU", "REGROWTHX HAIR REGROWTH TREATMENT MINOXIDIL", "DR. BOSLEY MINOXIDIL (FOR MEN) HAIR REGROWTH TREATMENT", "HAIR REGROWTH TREATMENT FOR MEN", "IBEALEE 5% MINOXIDIL HAIR REGROWTH SOLUTION", "FETE HEALTH HAIR REGROWTH TREATMENT FOR WOMEN", "HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN", "5%MINOXIDIL HAIR GROWTH SERUM", "LILIVERA HAIR REGROWTH KIT", "BOSLEY MINOXIDIL TOPICAL SOLUTION 5 (FOR MEN)", "MENS ROGAINE EXTRA STRENGTH UNSCENTED", "AMRWRIR 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "AROMATICA HAIR CHAMPU", "AROMATICA HAIR LEAVE IN ROMERO CON MINOXIDIL", "WOMENS MINOXIDIL HAIR GROWTH SYSTEM", "BERKLEY AND JENSEN MINOXIDIL", "HAPPY HEAD WOMENS HAIR REGROWTH TREATMENT", "CYPKEB 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "HAIR GROWTH SERUM ROLL-ON", "DS LABS SPECTRAL UHP MEN S EXTRA STRENGTH HAIR REGROWTH TREATMENT", "JOHNSON FOAM", "HAIR TREATMENT", "ELEVATE HAIR REGROWTH TREATMENT 5 MINOXIDIL SOLUTION", "MINOXIDIL HAIR REGROWTH KIT", "GROWELL MENS HAIR REGROWTH TREATMENT 5 MINOXIDIL", "ESALON HAIR REGROWTH TREATMENT WOMENS MINOXIDIL", "OCVWJKD 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "TRZSFR 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "WOMENS MINOGROW HAIR REGROWTH TREATMENT MINOXIDIL", "INTELLIGENT MENS MINOXIDIL EXTRA STRENGTH 5 MINOXIDIL", "HAIRFX HAIR GROWTH FOAM", "LEADER MINOXIDIL", "SOTI HAIR GROWTH SERUM", "HAIR-REGEN HAIR GROWTH TREATMENT", "SIDINOX 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "AROMATICA HAIR GOTA DE BRILLO ROMERO CON MINOXIDIL", "RDVHDLW 5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN", "IBEALEE 5-IN-1 5% MINOXIDIL HAIR REGROWTH SOLUTION", "TAGOQHIA MINOXIDIL HAIR THICKENING SERUM", "FOLLICLY MINOXIDIL HAIR REGROWTH TREATMENT", "KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN", "SOLUCION CAPILAR CRECEPELO", "5% MINOXIDIL HAIR GROWTH FOAM", "VENANOCI MINOXIDIL", "5% MINOXIDIL AND 5% ROSEMARY FOR HAIR CARE", "UP AND UP HAIR REGROWTH TREATMENT FOR MEN", "PROBLIVA MENS EXTRA STRENGTH MINOXIDIL", "REGOXIDINE (FOR MEN)", "HAPPY HEAD MENS EXTRA STRENGTH MINOXIDIL", "BLIYEOGZ 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "ROOTVIVE MENS HAIR REGROWTH TREATMENT EXTRA STRENGTH MINOXIDIL", "KEEPS MINOXIDIL TOPICAL", "MENS EXTRA STRENGTH MINOXIDIL HAIR GROWTH TREATMENT", "EZBIORT 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "NALIOPI 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "COLORSMITH HAIR REGROWTH TREATMENT MENS MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH", "MINOXIDIL 5% (FOR WOMEN)", "PSALMONICA HAIR GROWTH SERUM", "MINOXIDIL FOR MEN", "CAROLS DAUGHTER HAIR REGROWTH TREATMENT", "HAIR BEARDGROWTH FOAM", "TAGOQHA 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "UP AND UP HAIR REGROWTH TREATMENT FOR WOMEN", "MENS ROGAINE MINOXIDIL UNSCENTED FORMULA", "5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "SUAVECITO 5% MINOXIDIL SOLUTION", "MINOXIDIL TOPICAL" ], "generic_name": [ "MINOXIDIL", "MINOXIDIL FOAM 5% (WOMENS)" ], "manufacturer_name": [ "Guangdong Aimu Biological Technology Co., Ltd", "Clarity Cosmetics Inc.", "Shenzhen Ctrip Technology Co., Ltd.", "Shenzhen Xinxin Yunhai Technology Co., Ltd.", "CVS Pharmacy", "SCIENTIFIC HAIR RESEARCH, LLC", "WR Group, Inc.", "Hims Inc", "YIWUYIZHOUTRADINGCO.,LTD", "SANTO REMEDIO LLC", "Guangzhou Borderless Technology Co., Ltd.", "Guangzhou Xinhongda Trading Service Co., Ltd.", "Guangzhou Jianyuan Biological Technology.Co.,Ltd", "INNOVUS PHARMACEUTICALS, INC.", "Opus Meds LLC", "LABORATORIO MK SRL", "Veloce Trading Co., Limited", "Kroger Company", "Sam's West Inc", "Rite Aid Corporation", "VAPOR PRO SHOPPE, LLC", "Shenzhen Huayuan Hengsheng Technology Co., Ltd.", "Putian Licheng District Zhijiancheng Trading Co., Ltd.", "Shenzhen Earth Surface Trading Co., Ltd.", "Amazon.com Services LLC", "Roman Health Ventures Inc.", "Scientific Hair Research, LLC", "Cozesmo", "Salonceuticals, Inc.", "Safeway", "Walgreen Company", "Shenzhen Shandian Jingling Technology Co., Ltd.", "Yiwu Pu Feather Trading Co., LTD", "Publix Super Markets Inc", "RESTORATION HOLDINGS, LLC", "Aurohealth LLC", "CARDINAL HEALTH 110, LLC. DBA LEADER", "Guangdong Quadrant Ecological Technology Co., Ltd.", "SMC Essentials LLC", "APIRA SCIENCE, INC.", "Kenvue Brands LLC", "Good Manager Holdings Inc", "Kramer Laboratories", "Sun Pharmaceutical Industries, Inc.", "BosleyMD", "BELLEKA INC", "L. 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"pharm_class_moa": [ "5-alpha Reductase Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "MINOXIDIL", "drugbatchnumb": "1CV2247", "drugauthorizationnumb": "091344", "drugdosagetext": "1/2 CAPFUL, QD", "drugdosageform": "Cutaneous foam", "drugadministrationroute": "061", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "MINOXIDIL" }, "openfda": { "application_number": [ "M032", "ANDA209074", "ANDA091344", "ANDA078176", "ANDA075357", "505G(a)(3)", "ANDA218616", "ANDA076239", "ANDA075598", "NDA019501", "ANDA072709", "ANDA208092", "NDA021812", "ANDA075518", "NDA020834", "ANDA075438", "ANDA071826", "ANDA071839", "ANDA074588", "ANDA071344", "ANDA071345" ], "brand_name": [ "MELAO HAIR GROWTH MOUSSE", "MINOXIDIL", "5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN", "OLIVITA MINOXIDIL", "HAIR REGROWTH TREATMENT", "MINOXIDIL (FOR MEN)", "FOLIGAIN PROFESSIONAL SERIES EXTRA STRENGTH FOR WOMEN MINOXIDIL TOPICAL HAIR REGROWTH TREATMENT", "HIMS HAIR REGROWTH TREATMENT", "HAIR REGEN HAIR GROWTH TREATMENT", "SANTO REMEDIO MENS HAIR REGROWTH TREATMENT MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH UNSCENTED", "TACRUITF 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "GEMACHLICH ZUHAUSE BEARD GROWTH TREATMENT SERUM", "ELEVATE HAIR GROWTH SERUM", "AGIKENB 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "REGOXIDINE (FOR WOMEN)", "OPUSMEDS EXTRA STRENGTH MINOXIDIL", "HAIR LEAVE IN", "5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN", "5%MINOXIDIL TOPICAL FOAM", "MINOXIDIL 5% (FOR MEN)", "MEMBERS MARK HAIR REGROWTH TREATMENT", "ELEVATE HAIR REGROWTH TREATMENT 5", "BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM", "MINOXIDIL HAIR REGROWTH TREATMENT", "BASIC CARE HAIR REGROWTH TREATMENT", "FOLIGAIN PROFESSIONAL SERIES EXTRA STRENGTH FOR MEN MINOXIDIL HAIR REGROWTH TREATMENT", "MINOXIDIL EXTRA STRENGTH FOR MEN", "BOSLEY WOMAN 2 MINOXIDIL TOPICAL SOLUTION", "STAFENIT HAIR REGROWTH TREATMENT TOPICAL MINOXIDIL", "REGENPURE PRECISION", "HAIR GROWTH FOAM", "5% MINOXIDIL HAIR GROWTH TOPICAL SOLUTION", "MINOXIDIL FOR WOMEN", "ERWCNMIE 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "VERDIBLISS 5% MINOXIDIL TOPICAL HAIR REGROWTH TREATMENT FOR MEN", "MENS JIVEXA EXTRA STRENGTH MINOXIDIL", "GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL", "WOMENS ROGAINE UNSCENTED", "DAVV MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT", "AROMATICA HAIR ACONDICIONADOR ROMERO CON MINOXIDIL", "NIZORAL HAIR REGROWTH TREATMENT FOR MEN", "HAIR ACONDICIONADOR", "AROMATICA HAIR TRATAMIENTO ROMERO CON MINOXIDIL", "5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "TOMUM HAIR GROWTH TREATMENT FOR MEN MINOXIDIL UNSCENTED", "GOOD SENSE HAIR REGROWTH TREATMENT", "BOSLEY MAN 5 MINOXIDIL TOPICAL SOLUTION", "KERANIQUE 2% HAIR REGROWTH TREATMENT FOR WOMEN", "TAGOQHIA 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "5% MINOXIDIL HAIR REGROWTH TREATMENT", "5% MINOXIDIL(FOR MEN)", "NUVARRA MENS MINOXIDIL HAIR REGROWTH TREATMENT", "HERS HAIR REGROWTH TREATMENT", "KIRKLAND SIGNATURE MINOXIDIL", "MINOXIDIL (FOR WOMEN)", "5%MINOXIDIL HAIR GROWTH SPRAYS SERUM", "5% MINOXIDIL WITH BIOTIN", "BOSLEY MINOXIDIL TOPICAL SOLUTION 2 FOR WOMEN", "MINOXIDIL HAIR GROWTH SERUM", "SANTO REMEDIO WOMENS HAIR REGROWTH TREATMENT MINOXIDIL UNSCENTED", "ETADERM MENS MINOXIDIL HAIR REGROWTH TREATMENT EXTRA STRENGTH", "TNEGHC 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "BEHATMH 5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN", "MINOXIDIL 5 PERCENT (FOR WOMEN)", "REGENIVADE HAIR GROWTH FOAM", "HAIR GROWTH SOLUTION", "CLEVARIEL MINOXIDIL HAIR GROWTH SERUM", "EQUATE HAIR REGROWTH TREATMENT", "THE ROOT OF GOODNESS HEALTHY GROWTH HAIR REGROWTH SYSTEM FOR WOMEN 3 STEP SYSTEM", "5%MINOXIDIL TOPICAL AEROSOL(FOR MEN)", "HAIR CHAMPU", "REGROWTHX HAIR REGROWTH TREATMENT MINOXIDIL", "DR. BOSLEY MINOXIDIL (FOR MEN) HAIR REGROWTH TREATMENT", "HAIR REGROWTH TREATMENT FOR MEN", "IBEALEE 5% MINOXIDIL HAIR REGROWTH SOLUTION", "FETE HEALTH HAIR REGROWTH TREATMENT FOR WOMEN", "HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN", "5%MINOXIDIL HAIR GROWTH SERUM", "LILIVERA HAIR REGROWTH KIT", "BOSLEY MINOXIDIL TOPICAL SOLUTION 5 (FOR MEN)", "MENS ROGAINE EXTRA STRENGTH UNSCENTED", "AMRWRIR 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "AROMATICA HAIR CHAMPU", "AROMATICA HAIR LEAVE IN ROMERO CON MINOXIDIL", "WOMENS MINOXIDIL HAIR GROWTH SYSTEM", "BERKLEY AND JENSEN MINOXIDIL", "HAPPY HEAD WOMENS HAIR REGROWTH TREATMENT", "CYPKEB 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "HAIR GROWTH SERUM ROLL-ON", "DS LABS SPECTRAL UHP MEN S EXTRA STRENGTH HAIR REGROWTH TREATMENT", "JOHNSON FOAM", "HAIR TREATMENT", "ELEVATE HAIR REGROWTH TREATMENT 5 MINOXIDIL SOLUTION", "MINOXIDIL HAIR REGROWTH KIT", "GROWELL MENS HAIR REGROWTH TREATMENT 5 MINOXIDIL", "ESALON HAIR REGROWTH TREATMENT WOMENS MINOXIDIL", "OCVWJKD 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "TRZSFR 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "WOMENS MINOGROW HAIR REGROWTH TREATMENT MINOXIDIL", "INTELLIGENT MENS MINOXIDIL EXTRA STRENGTH 5 MINOXIDIL", "HAIRFX HAIR GROWTH FOAM", "LEADER MINOXIDIL", "SOTI HAIR GROWTH SERUM", "HAIR-REGEN HAIR GROWTH TREATMENT", "SIDINOX 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "AROMATICA HAIR GOTA DE BRILLO ROMERO CON MINOXIDIL", "RDVHDLW 5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN", "IBEALEE 5-IN-1 5% MINOXIDIL HAIR REGROWTH SOLUTION", "TAGOQHIA MINOXIDIL HAIR THICKENING SERUM", "FOLLICLY MINOXIDIL HAIR REGROWTH TREATMENT", "KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN", "SOLUCION CAPILAR CRECEPELO", "5% MINOXIDIL HAIR GROWTH FOAM", "VENANOCI MINOXIDIL", "5% MINOXIDIL AND 5% ROSEMARY FOR HAIR CARE", "UP AND UP HAIR REGROWTH TREATMENT FOR MEN", "PROBLIVA MENS EXTRA STRENGTH MINOXIDIL", "REGOXIDINE (FOR MEN)", "HAPPY HEAD MENS EXTRA STRENGTH MINOXIDIL", "BLIYEOGZ 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "ROOTVIVE MENS HAIR REGROWTH TREATMENT EXTRA STRENGTH MINOXIDIL", "KEEPS MINOXIDIL TOPICAL", "MENS EXTRA STRENGTH MINOXIDIL HAIR GROWTH TREATMENT", "EZBIORT 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "NALIOPI 5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION", "COLORSMITH HAIR REGROWTH TREATMENT MENS MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH", "MINOXIDIL 5% (FOR WOMEN)", "PSALMONICA HAIR GROWTH SERUM", "MINOXIDIL FOR MEN", "CAROLS DAUGHTER HAIR REGROWTH TREATMENT", "HAIR BEARDGROWTH FOAM", "TAGOQHA 5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "UP AND UP HAIR REGROWTH TREATMENT FOR WOMEN", "MENS ROGAINE MINOXIDIL UNSCENTED FORMULA", "5% MINOXIDIL HAIR GROWTH SPRAYS SERUM", "SUAVECITO 5% MINOXIDIL SOLUTION", "MINOXIDIL TOPICAL" ], "generic_name": [ "MINOXIDIL", "MINOXIDIL FOAM 5% (WOMENS)" ], "manufacturer_name": [ "Guangdong Aimu Biological Technology Co., Ltd", "Clarity Cosmetics Inc.", "Shenzhen Ctrip Technology Co., Ltd.", "Shenzhen Xinxin Yunhai Technology Co., Ltd.", "CVS Pharmacy", "SCIENTIFIC HAIR RESEARCH, LLC", "WR Group, Inc.", "Hims Inc", "YIWUYIZHOUTRADINGCO.,LTD", "SANTO REMEDIO LLC", "Guangzhou Borderless Technology Co., Ltd.", "Guangzhou Xinhongda Trading Service Co., Ltd.", "Guangzhou Jianyuan Biological Technology.Co.,Ltd", "INNOVUS PHARMACEUTICALS, INC.", "Opus Meds LLC", "LABORATORIO MK SRL", "Veloce Trading Co., Limited", "Kroger Company", "Sam's West Inc", "Rite Aid Corporation", "VAPOR PRO SHOPPE, LLC", "Shenzhen Huayuan Hengsheng Technology Co., Ltd.", "Putian Licheng District Zhijiancheng Trading Co., Ltd.", "Shenzhen Earth Surface Trading Co., Ltd.", "Amazon.com Services LLC", "Roman Health Ventures Inc.", "Scientific Hair Research, LLC", "Cozesmo", "Salonceuticals, Inc.", "Safeway", "Walgreen Company", "Shenzhen Shandian Jingling Technology Co., Ltd.", "Yiwu Pu Feather Trading Co., LTD", "Publix Super Markets Inc", "RESTORATION HOLDINGS, LLC", "Aurohealth LLC", "CARDINAL HEALTH 110, LLC. 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"2736944", "2736946", "2736948" ], "spl_id": [ "5176eed4-f8f8-4f88-a079-11f16864f40a" ], "spl_set_id": [ "27f15fac-7d98-4114-a2ec-92494a91da98" ], "package_ndc": [ "0169-1715-30", "0169-1715-90", "0169-1704-30", "0169-1709-30", "0169-4303-01", "0169-4303-13", "0169-4303-90", "0169-4303-93", "0169-4303-30", "0169-4303-99", "0169-4307-01", "0169-4307-13", "0169-4307-30", "0169-4314-01", "0169-4314-13", "0169-4314-30", "0169-4815-30", "0169-4815-90", "0169-4804-30", "0169-4809-30" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "53AXN4NNHX" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Blood cholesterol increased", "actiondrug": "6", "drugadditional": "4", 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"0378-0218-01", "0378-0218-10", "0378-0231-01", "0378-0231-10", "0378-0757-01", "0378-0757-10", "68382-022-16", "68382-022-01", "68382-022-10", "68382-022-40", "68382-022-24", "68382-023-16", "68382-023-01", "68382-023-10", "68382-023-02", "68382-023-40", "68382-023-24", "68382-024-16", "68382-024-01", "68382-024-10", "68382-024-40", "0093-0787-01", "0093-0787-10", "0093-0752-01", "0093-0752-10", "0093-0753-01", "0093-0753-05" ], "nui": [ "N0000000161", "N0000175556" ], "pharm_class_moa": [ "Adrenergic beta-Antagonists [MoA]" ], "pharm_class_epc": [ "beta-Adrenergic Blocker [EPC]" ], "unii": [ "50VV3VW0TI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BUPROPION", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Depression", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "BUPROPION" }, "openfda": { "application_number": [ "ANDA201567" ], "brand_name": [ "BUPROPION" ], "generic_name": [ "BUPROPION" ], "manufacturer_name": [ "Zydus Pharmaceuticals USA Inc.", "Zydus Lifesciences Limited" ], "product_ndc": [ "68382-353", "68382-354", "65841-780", "65841-836" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BUPROPION HYDROCHLORIDE" ], "rxcui": [ "993541", "993557" ], "spl_id": [ "00be046c-e051-4430-a967-3a0d4611da22", "6c831525-a7c2-4ef1-b1b9-c7e8cb807ded" ], "spl_set_id": [ "8d937ca3-3351-40f1-8192-348ba0c68162", "78d34aad-9d4f-48c4-91eb-536e31c6b6c9" ], "package_ndc": [ "68382-354-06", "68382-354-16", "68382-354-05", "68382-354-10", "68382-353-06", "68382-353-16", "68382-353-05", "68382-353-10", "65841-780-06", "65841-780-16", "65841-780-05", "65841-780-10", "65841-836-06", "65841-836-16", "65841-836-05", "65841-836-10" ], "unii": [ "ZG7E5POY8O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TRAZODONE", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Insomnia", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "LOSARTAN", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Hypertension", "drugstartdateformat": "610", "drugstartdate": "202106", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "LOSARTAN" }, "openfda": { "application_number": [ "ANDA215959" ], "brand_name": [ "LOSARTAN POTASSIUM" ], "generic_name": [ "LOSARTAN" ], "manufacturer_name": [ "Granules Pharmaceuticals Inc.", "Granules India Ltd" ], "product_ndc": [ "70010-741", "70010-742", "70010-743", "62207-741", "62207-742", "62207-743" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOSARTAN POTASSIUM" ], "rxcui": [ "979480", "979485", "979492" ], "spl_id": [ "451da3de-077d-522d-e063-6394a90a3537", "39e0a359-f9d7-c3fb-e063-6394a90a86a8" ], "spl_set_id": [ "ca012edc-923d-4ada-a261-db82b71b3c4f", "f9953f51-f30a-952d-e053-6394a90abf5f" ], "package_ndc": [ "70010-741-03", "70010-741-09", "70010-741-10", "70010-742-03", "70010-742-09", "70010-742-10", "70010-743-03", "70010-743-09", "70010-743-10", "62207-741-54", "62207-741-49", "62207-742-54", "62207-742-49", "62207-743-54", "62207-743-49" ], "unii": [ "3ST302B24A" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PANTOPRAZOLE", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Dyspepsia", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "openfda": { "application_number": [ "ANDA202882", "ANDA205119", "ANDA077619" ], "brand_name": [ "PANTOPRAZOLE SODIUM", "PANTOPRAZOLE" ], "generic_name": [ "PANTOPRAZOLE" ], "manufacturer_name": [ "XLCare Pharmaceuticals Inc.", "Quallent Pharmaceuticals Health LLC", "Amneal Pharmaceuticals LLC", "Camber Pharmaceuticals, Inc.", "NorthStar RxLLC", "Dr.Reddy's Laboratories Limited" ], "product_ndc": [ "72865-229", "72865-230", "82009-010", "82009-011", "65162-636", "65162-637", "31722-712", "31722-713", "72603-177", "72603-178", "55111-332", "55111-333" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PANTOPRAZOLE SODIUM" ], "rxcui": [ "251872", "314200" ], "spl_id": [ "f26fc428-a419-1008-e053-2a95a90a83fc", "48430767-cec0-15e0-e063-6394a90ac032", "940df77d-5373-4196-946e-19271ac91087", "48f42a12-2eac-e5dd-e063-6294a90aa92d", "57338853-6995-de1e-62ca-be5505c8d656", "c0575fc6-20c4-12a6-10b7-1af65cac1ee0" ], "spl_set_id": [ "17468dbf-84b6-4c53-9ad5-341350d2cfab", "643eb498-d916-4fb7-9281-32895575ab36", "f3ded82a-cf0d-4844-944a-75f9f9215ff0", "9daa1483-5a36-44db-9e0d-904d100da262", "82f0103a-2b97-d210-6d7d-c627d60ad694", "564709e8-358f-c185-4ecb-b3849c3fe59c" ], "package_ndc": [ "72865-229-90", "72865-230-90", "72865-230-10", "82009-010-90", "82009-011-90", "82009-011-10", "65162-636-03", "65162-636-09", "65162-637-03", "65162-637-09", "65162-637-50", "65162-637-11", "31722-712-90", "31722-712-32", "31722-712-31", "31722-713-90", "31722-713-32", "31722-713-31", "31722-713-10", "72603-177-01", "72603-178-01", "55111-332-30", "55111-332-90", "55111-332-01", "55111-332-05", "55111-332-10", "55111-332-79", "55111-332-81", "55111-332-78", "55111-333-30", "55111-333-90", "55111-333-01", "55111-333-05", "55111-333-10", "55111-333-79", "55111-333-81", "55111-333-78" ], "unii": [ "6871619Q5X" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEVOTHYROXINE", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Hypothyroidism", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "LEVOTHYROXINE" } }, { "drugcharacterization": "2", "medicinalproduct": "VASCEPA", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Blood triglycerides increased", "drugstartdateformat": "610", "drugstartdate": "202106", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "ICOSAPENT ETHYL" }, "openfda": { "application_number": [ "NDA202057" ], "brand_name": [ "VASCEPA" ], "generic_name": [ "ICOSAPENT ETHYL" ], "manufacturer_name": [ "Amarin Pharma Inc." ], "product_ndc": [ "52937-001", "52937-101", "52937-003", "52937-005" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ICOSAPENT ETHYL" ], "rxcui": [ "1304979", "1304985", "1811180", "1811182" ], "spl_id": [ "86b35fe3-d1cf-478e-849b-2ea0c87bda33" ], "spl_set_id": [ "9c1a2828-1583-4414-ab22-a60480e8e508" ], "package_ndc": [ "52937-001-04", "52937-001-20", "52937-001-21", "52937-101-08", "52937-003-40", "52937-003-16", "52937-005-20" ], "unii": [ "6GC8A4PAYH" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Diabetes mellitus", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "UNSPECIFIED INGREDIENT", "drugbatchnumb": "Unknown", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Diabetes mellitus", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "UNSPECIFIED INGREDIENT" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20151101" } } }, { "safetyreportversion": "10", "safetyreportid": "13393462", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20220721", "reporttype": "1", "serious": "2", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20170331", "receiptdateformat": "102", "receiptdate": "20220527", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2017135988", "duplicate": "1", "reportduplicate": { "duplicatesource": "Pfizer", "duplicatenumb": "US-PFIZER INC-2017136603" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "66", "patientonsetageunit": "801", "patientweight": "69.4", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Product use issue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Depression", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Migraine", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "SOMAVERT", "drugauthorizationnumb": "21106", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "10 MG, WEEKLY", "drugdosageform": "Powder and solvent for solution for injection", "drugindication": "Acromegaly", "drugstartdateformat": "610", "drugstartdate": "201012", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "PEGVISOMANT" }, "openfda": { 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"drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, 1X/DAY", "drugdosageform": "Powder and solvent for solution for injection", "drugindication": "Gigantism", "drugstartdateformat": "102", "drugstartdate": "20101220", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "PEGVISOMANT" }, "openfda": { "application_number": [ "BLA021106" ], "brand_name": [ "SOMAVERT" ], "generic_name": [ "PEGVISOMANT" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC" ], "product_ndc": [ "0009-7166", "0009-7168", "0009-7188", "0009-7199", "0009-7200" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "403806", "403807", "403808", "404457", "404458", "404459", "1549323", "1549452", "1549454", "1549456" ], "spl_id": [ "36dc9264-0f75-4059-ac68-65fa4bfcdcc2" ], "spl_set_id": [ "3cbb485b-6df1-49ce-8747-592b395b1988" ], "package_ndc": [ "0009-7166-01", "0009-7166-30", "0009-5175-02", "0009-5936-01", "0009-7168-01", "0009-7168-30", "0009-5177-02", "0009-7188-01", "0009-7188-30", "0009-5179-02", "0009-7199-01", "0009-7199-30", "0009-5201-04", "0009-7200-01", "0009-7200-30", "0009-5376-04" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SOMAVERT", "drugauthorizationnumb": "21106", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, 1X/DAY", "drugdosageform": "Powder and solvent for solution for injection", "drugstartdateformat": "102", "drugstartdate": "20161010", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "PEGVISOMANT" }, "openfda": { "application_number": [ "BLA021106" ], "brand_name": [ "SOMAVERT" ], "generic_name": [ "PEGVISOMANT" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC" ], "product_ndc": [ "0009-7166", "0009-7168", "0009-7188", "0009-7199", "0009-7200" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "403806", "403807", "403808", "404457", "404458", "404459", "1549323", "1549452", "1549454", "1549456" ], "spl_id": [ "36dc9264-0f75-4059-ac68-65fa4bfcdcc2" ], "spl_set_id": [ "3cbb485b-6df1-49ce-8747-592b395b1988" ], "package_ndc": [ "0009-7166-01", "0009-7166-30", "0009-5175-02", "0009-5936-01", "0009-7168-01", "0009-7168-30", "0009-5177-02", "0009-7188-01", "0009-7188-30", "0009-5179-02", "0009-7199-01", "0009-7199-30", "0009-5201-04", "0009-7200-01", "0009-7200-30", "0009-5376-04" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SOMAVERT", "drugauthorizationnumb": "21106", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, DAILY", "drugdosageform": "Powder and solvent for solution for injection", "drugstartdateformat": "102", "drugstartdate": "20161207", "drugenddateformat": "610", "drugenddate": "201707", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "PEGVISOMANT" }, "openfda": { "application_number": [ "BLA021106" ], "brand_name": [ "SOMAVERT" ], "generic_name": [ "PEGVISOMANT" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC" ], "product_ndc": [ "0009-7166", "0009-7168", "0009-7188", "0009-7199", "0009-7200" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "403806", "403807", "403808", "404457", "404458", "404459", "1549323", "1549452", "1549454", "1549456" ], "spl_id": [ "36dc9264-0f75-4059-ac68-65fa4bfcdcc2" ], "spl_set_id": [ "3cbb485b-6df1-49ce-8747-592b395b1988" ], "package_ndc": [ "0009-7166-01", "0009-7166-30", "0009-5175-02", "0009-5936-01", "0009-7168-01", "0009-7168-30", "0009-5177-02", "0009-7188-01", "0009-7188-30", "0009-5179-02", "0009-7199-01", "0009-7199-30", "0009-5201-04", "0009-7200-01", "0009-7200-30", "0009-5376-04" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SOMAVERT", "drugauthorizationnumb": "21106", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "20 MG, 2X/WEEK", "drugdosageform": "Powder and solvent for solution for injection", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "PEGVISOMANT" }, "openfda": { "application_number": [ "BLA021106" ], "brand_name": [ "SOMAVERT" ], "generic_name": [ "PEGVISOMANT" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC" ], "product_ndc": [ "0009-7166", "0009-7168", "0009-7188", "0009-7199", "0009-7200" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "403806", "403807", "403808", "404457", "404458", "404459", "1549323", "1549452", "1549454", "1549456" ], "spl_id": [ "36dc9264-0f75-4059-ac68-65fa4bfcdcc2" ], "spl_set_id": [ "3cbb485b-6df1-49ce-8747-592b395b1988" ], "package_ndc": [ "0009-7166-01", "0009-7166-30", "0009-5175-02", "0009-5936-01", "0009-7168-01", "0009-7168-30", "0009-5177-02", "0009-7188-01", "0009-7188-30", "0009-5179-02", "0009-7199-01", "0009-7199-30", "0009-5201-04", "0009-7200-01", "0009-7200-30", "0009-5376-04" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SANDOSTATIN", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "30 MG, MONTHLY", "drugadministrationroute": "030", "drugindication": "Acromegaly", "drugstartdateformat": "102", "drugstartdate": "20160309", "drugenddateformat": "102", "drugenddate": "20161010", "drugtreatmentduration": "216", "drugtreatmentdurationunit": "804", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA019667" ], "brand_name": [ "SANDOSTATIN" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0180", "0078-0181", "0078-0182" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "OCTREOTIDE ACETATE" ], "rxcui": [ "207194", "207198", "207200", "312068", "312069", "312070" ], "spl_id": [ "3f1a424d-05a3-40d6-8127-44948e411611" ], "spl_set_id": [ "4e2c9856-1836-49f0-9472-4dbeeb408f39" ], "package_ndc": [ "0078-0180-61", "0078-0180-01", "0078-0181-61", "0078-0181-01", "0078-0182-61", "0078-0182-01" ], "unii": [ "75R0U2568I" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RYBELSUS", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "003", "drugdosagetext": "3 MG", "drugindication": "Diabetes mellitus", "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "openfda": { "application_number": [ "NDA213051" ], "brand_name": [ "RYBELSUS" ], "generic_name": [ "ORAL SEMAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk Pharmaceutical Industries, LP" ], "product_ndc": [ "0169-4303", "0169-1715", "0169-1704", "0169-1709", "0169-4307", "0169-4314", "0169-4815", "0169-4804", "0169-4809" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SEMAGLUTIDE" ], "rxcui": [ "2200644", "2200650", "2200652", "2200654", "2200656", "2200658", "2707547", "2707549", "2707551", "2707553", "2707555", "2707557", "2736944", "2736946", "2736948" ], "spl_id": [ "5176eed4-f8f8-4f88-a079-11f16864f40a" ], "spl_set_id": [ "27f15fac-7d98-4114-a2ec-92494a91da98" ], "package_ndc": [ "0169-1715-30", "0169-1715-90", "0169-1704-30", "0169-1709-30", "0169-4303-01", "0169-4303-13", "0169-4303-90", "0169-4303-93", "0169-4303-30", "0169-4303-99", "0169-4307-01", "0169-4307-13", "0169-4307-30", "0169-4314-01", "0169-4314-13", "0169-4314-30", "0169-4815-30", "0169-4815-90", "0169-4804-30", "0169-4809-30" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "53AXN4NNHX" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20101220" } } }, { "safetyreportversion": "5", "safetyreportid": "14586923", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20250115", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20180301", "receiptdateformat": "102", "receiptdate": "20241011", "fulfillexpeditecriteria": "1", "companynumb": "CA-TAKEDA-2018TUS004911", "primarysource": { "reportercountry": "CA", "qualification": "5" }, "sender": { "sendertype": "1", "senderorganization": "TAKEDA" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "50", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Osteonecrosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Musculoskeletal stiffness", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Bone scan abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Arthralgia", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugbatchnumb": "11386721", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MILLIGRAM", "drugdosageform": "Powder for solution for infusion", "drugadministrationroute": "042", "drugindication": "Crohn^s disease", "drugstartdateformat": "102", "drugstartdate": "20180124", "actiondrug": "4", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugbatchnumb": "12737543", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "4", "drugintervaldosagedefinition": "803", "drugdosagetext": "300 MILLIGRAM, Q4WEEKS", "drugdosageform": "Powder for solution for infusion", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20180921", "actiondrug": "4", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METOPROLOL", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MILLIGRAM, QD", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "METOPROLOL" }, "openfda": { "application_number": [ "ANDA078950", "ANDA091045", "ANDA202871", "ANDA090317" ], "brand_name": [ "METOPROLOL", "METOPROLOL TARTRATE" ], "generic_name": [ "METOPROLOL TARTRATE", "METOPROLOL", "METOPROLOL TARTRATE INJECTION" ], "manufacturer_name": [ "Baxter Healthcare Corporation", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Oneosource Specialty Pharma Limited", "Alembic Pharmaceuticals Limited" ], "product_ndc": [ "36000-033", "63323-660", "62332-112", "62332-113", "62332-114", "65219-665", "83270-177", "46708-290", "46708-291", "46708-292" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "METOPROLOL TARTRATE" ], "rxcui": [ "866508", "866511", "866514", "866924" ], "spl_id": [ "5d975af3-d078-4130-9448-ed77123f1aac", "4066607a-15cb-42ac-999e-5254907dda5a", "c7738f42-299e-4bea-af50-778e069352f0", "ccb1a15e-c943-4042-ae46-550bdabfc96b", "571d8a14-0118-d00c-e063-6394a90a2769", "f31d2aef-f902-4984-803c-5bdb015e9253" ], "spl_set_id": [ 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"2200658", "2707547", "2707549", "2707551", "2707553", "2707555", "2707557", "2736944", "2736946", "2736948" ], "spl_id": [ "5176eed4-f8f8-4f88-a079-11f16864f40a" ], "spl_set_id": [ "27f15fac-7d98-4114-a2ec-92494a91da98" ], "package_ndc": [ "0169-1715-30", "0169-1715-90", "0169-1704-30", "0169-1709-30", "0169-4303-01", "0169-4303-13", "0169-4303-90", "0169-4303-93", "0169-4303-30", "0169-4303-99", "0169-4307-01", "0169-4307-13", "0169-4307-30", "0169-4314-01", "0169-4314-13", "0169-4314-30", "0169-4815-30", "0169-4815-90", "0169-4804-30", "0169-4809-30" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "53AXN4NNHX" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20180206" } } }, { "safetyreportversion": "6", "safetyreportid": "14706699", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20240410", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20180402", "receiptdateformat": "102", "receiptdate": "20240308", "fulfillexpeditecriteria": "1", "companynumb": "US-SHIRE-US201812324", "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "56", "patientonsetageunit": "801", "patientweight": "201", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "26.1", "reactionmeddrapt": "Influenza", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "26.1", "reactionmeddrapt": "Hereditary angioedema", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "26.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LANADELUMAB", "drugauthorizationnumb": "761090", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugdosagetext": "300 MILLIGRAM, Q2WEEKS", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Hereditary angioedema", "drugstartdateformat": "102", "drugstartdate": "20210519", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "LANADELUMAB" } }, { "drugcharacterization": "1", "medicinalproduct": "LANADELUMAB", "drugauthorizationnumb": "761090", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugdosagetext": "300 MILLIGRAM, Q2WEEKS", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Immune system disorder", "drugstartdateformat": "102", "drugstartdate": "20210910", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "LANADELUMAB" } }, { "drugcharacterization": "1", "medicinalproduct": "CINRYZE", "drugauthorizationnumb": "11838", "drugstructuredosagenumb": "1500", "drugstructuredosageunit": "025", "drugdosagetext": "1500 INTERNATIONAL UNIT", "drugdosageform": "Powder and solvent for solution for injection", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "20140614", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "HUMAN C1-ESTERASE INHIBITOR" } }, { "drugcharacterization": "1", "medicinalproduct": "CINRYZE", "drugauthorizationnumb": "11838", "drugstructuredosagenumb": "1500", "drugstructuredosageunit": "025", "drugdosagetext": "1500 INTERNATIONAL UNIT", "drugdosageform": "Powder and solvent for solution for injection", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "20140614", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "HUMAN C1-ESTERASE INHIBITOR" } }, { "drugcharacterization": "1", "medicinalproduct": "CINRYZE", "drugauthorizationnumb": "11838", "drugstructuredosagenumb": "1500", "drugstructuredosageunit": "025", "drugdosagetext": "1500 INTERNATIONAL UNIT", "drugdosageform": "Powder and solvent for solution for injection", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": 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"42543-714", "67877-276", "31722-758", "31722-759", "72205-199" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CLOPIDOGREL BISULFATE", "CLOPIDOGREL" ], "rxcui": [ "309362", "213169", "749196", "749198" ], "spl_id": [ "dbf6d86e-5d4f-40da-a933-b928843053b7", "a9df5ba4-ab12-4f72-9264-a1f7f377e35b", "360ed8dd-4f92-46fc-b31b-abe0d75e9bb3", "3cbfb162-4652-4a90-9afa-489e743fc16a", "05355b6d-3802-4542-bda2-cd6a17e57266", "ed60a9e7-49f4-469c-bb7a-08e1bb6057e2", "175ba166-6dc4-41d9-a75e-853cb6d47aeb", "9e3256b5-2032-4615-967d-449d49b09921", "ff58c1f3-4875-4d10-aca7-c622af163cef", "936a8707-dc3c-ebe4-6a66-0f726988c764", "4b480542-0dd3-4694-9d43-d5fdcdd64a0f", "21dbc638-2bc8-4ad0-bacd-e79907affc2b", "04d99965-cea0-8e7d-e063-6394a90ab281", "0b4edca9-12af-4534-baad-4fa5c1cc9ac8" ], "spl_set_id": [ "d176de1d-b1b3-4aa9-b783-d53f65a79e50", "bc747f6d-f52c-4dcb-bda5-2d0a9f954147", "0d010775-1160-4b2e-a928-563a02edd191", "ae07b785-b522-41c6-b27c-24c4d5cd814d", 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"drugindication": "Angina pectoris", "drugstartdateformat": "102", "drugstartdate": "20220824", "activesubstance": { "activesubstancename": "ASPIRIN" }, "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL 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Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LANSOPRAZOLE", "drugadministrationroute": "048", "drugindication": "Abdominal discomfort", "drugstartdateformat": "102", "drugstartdate": "20220824", "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "openfda": { "application_number": [ "ANDA207394", "ANDA202319", "NDA208025", "ANDA091269", "ANDA203187", "ANDA207167", "ANDA210465", "ANDA203083", "ANDA202194", "ANDA203957", "NDA020406", "NDA021428", "ANDA203203", "ANDA208671", "ANDA202396", "ANDA200816", "ANDA090763", "ANDA205868", "ANDA077255", "ANDA208784" ], "brand_name": [ "LANSOPRAZOLE", "BASIC CARE LANSOPRAZOLE", "EQUATE LANSOPRAZOLE DELAYED RELEASE", "EQUATE LANSOPRAZOLE", "PREVACID 24 HR", "BERKLEY AND JENSEN LANSOPRAZOLE", "TOPCARE LANSOPRAZOLE", "CAREONE ACID REDUCER", "GOOD SENSE LANSOPRAZOLE", "UP AND UP LANSOPRAZOLE", "PREVACID", "PREVACID SOLUTAB", "DG HEALTH LANSOPRAZOLE", "KIRKLAND SIGNATURE 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"reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infusion site swelling", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infusion site erythema", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthma", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypersensitivity", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemorrhage", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HUMAN IMMUNOGLOBULIN G\\HYALURONIDASE RECOMBINANT HUMAN", "drugauthorizationnumb": "125402", "drugstructuredosagenumb": "37.5", "drugstructuredosageunit": "002", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "4", "drugintervaldosagedefinition": "803", "drugdosagetext": "37.5 GRAM, Q4WEEKS", "drugdosageform": "Solution for infusion", "drugindication": "Immunodeficiency common variable", "drugstartdateformat": 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"drugdosagetext": "UNK", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "openfda": { "application_number": [ "M013", "ANDA211544", "ANDA075077", "part343", "ANDA215486", "NDA019872", "ANDA070607", "M013.50", "ANDA207229", "ANDA078569", "M012", "ANDA216617", "ANDA070608", "ANDA213255", "ANDA219215", "ANDA219096", "ANDA204052", "ANDA214331", "NDA204957", "NDA018337", "M", "ANDA215403", "ANDA202605", "NDA204767", "ANDA216592", "ANDA076200", "NDA206968", "ANDA210969" ], "brand_name": [ "AMAZON BASIC CARE ACETAMINOPHEN", "PAIN RELIEF", "MAXIMUM STRENGTH NON-ASPIRIN 100", "MAXIMUM STRENGTH NON-ASPIRIN 250", "INFANTS PAIN FEVER", "TOPCARE PAIN RELIEF", "ACETAMINOPHEN", "PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE", "PAIN RELIEVER EXTRA STRENGTH", "8 HOUR ARTHRITIS PAIN", "PAIN RELIEVER", "CHILDRENS PAIN AND FEVER", "TOPCARE CHILDRENS PAIN AND FEVER", "TOPCARE 8 HR ARTHRITIS PAIN RELIEF", "APAP", "FOSTER AND THRIVE PAIN RELIEVER", "DYE FREE INFANTS PAIN AND FEVER", "CHILDRENS TYLENOL", "GENEXA ACETAMINOPHEN EXTRA STRENGTH", "ARTHRITIS PAIN RELIEVER", "MEDLINE", "ARTHRITIS PAIN RELIEF", "TYLENOL EXTRA STRENGTH", "DR SIMI PAIN RELIEF 100", "EXTRA STRENGTH ACETAMINOPHEN", "EXTRA STRENGTH PAIN RELIEF", "INFANTS PAIN RELIEVER", "HEB", "ACETAMINOPHEN EXTRA STRENGTH", "CAREALL ACETAMINOPHEN", "PAIN AND FEVER", "PAIN RELIEF EXTRA STRENGTH", "LEADER INFANTS PAIN AND FEVER", "CHILDRENS ACETAMINOPHEN", "TYLENOL 8 HR MUSCLE ACHES AND PAIN", "CHILDRENS CHEWABLE ACETAMINOPHEN", "PAIN RELIEF CHILDRENS", "TYLENOL 8 HR ARTHRITIS PAIN", "PAIN RELIEF REGULAR STRENGTH", "TYLENOL FOR CHILDREN PLUS ADULTS", "ACETAMINOPHEN FOR CHILDREN", "INFANTS PAIN AND FEVER", "UP AND UP ACETAMINOPHEN INFANTS", "TYLENOL REGULAR STRENGTH", "CHILDRENS PAIN RELIEF", "DG HEALTH CHILDRENS PAIN AND FEVER", "RAPIDOL 500 EXTRA STRENGTH", "CVS CHILDRENS PAIN PLUS FEVER RELIEF", "CHILDRENS PAIN AND FEVER RELIEF", "INFANTS FEVER REDUCER AND PAIN RELIEVER", "GOOD NEIGHBOR PHARMACY INFANTS PAIN AND FEVER", "CHILDREN ACETAMINOPHEN ORAL SOLUTION", "ACETAMINOPHEN REGULAR STRENGTH", "PEDIACARE CHILDRENS GRAPE", "NEO-LUBRINA", "ACETAMINOPHEN EASY TABS EXTRA STRENGTH", "GOOD NEIGHBOR PHARMACY PAIN RELIEF", "CHILDRENS PAIN RELIEVER", "EQUATE PAIN RELIEVER", "NIGHTTIME COLD AND FLU RELIEF", "CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER", "AMAZON BASICS ACETAMINOPHEN", "FOSTER AND THRIVE INFANTS PAIN AND FEVER", "TOPCARE INFANTS PAIN AND FEVER", "SIGNATURE CARE CHILDRENS PAIN RELIEF", "CABINET PAIN RELIEVER AND FEVER REDUCER REFILL ACETAMINOPHEN", "CVS ACETAMINOPHEN", "PANADOL EXTRA STRENGTH", "BASIC CARE CHILDRENS PAIN AND FEVER", "8HR MUSCLE ACHES AND PAIN", "MEDIQUE EXTRA STRENGTH APAP", "MEDI-FIRST EXTRA STRENGTH NON-ASPIRIN", "MEDI-FIRST PLUS EXTRA STRENGTH NON-ASPIRIN", "EXTRA STRENGTH PAIN RELIEVER", "BASIC CARE INFANTS PAIN AND FEVER", "GOOD SENSE PAIN RELIEF", "PAIN RELIEF ACETAMINOPHEN 325 MG", "REVASOL ACETAMINOPHEN SUSPENSION", "MEDIQUE APAP EXTRA STRENGTH", "MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH", "MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH", "ACETAMINOPHEN 500 MG", "EQUATE PAIN AND FEVER INFANTS", "REGULAR STRENGTH PAIN RELIEVER", "DYE FREE CHILDRENS ACETAMINOPHEN", "EQUATE 8HR ARTHRITIS PAIN RELIEF", "8 HOUR PAIN RELIEF", "EQUATE PAIN RELIEVER ACETAMINOPHEN FOR ADULTS 250 MG", "M-PAP", "INFANTS PAIN RELIEF", "ACETAMINOPHEN 325MG", "REVASOL ACETAMINOPHEN SUSPENSION DYE FREE", "DURALGINA EXTRA STRENGTH", "KINDERFARMS INFANTS PAIN AND FEVER", "DYE FREE PAIN RELIEVER CHILDRENS", "ULINE ACETAMINOPHEN EXTRA STRENGTH", "PAIN RELIEF FEVER REDUCER CHILDREN", "BACTIMICINA CHILDRENS PAIN AND FEVER", "DOLO- NEUROBION ACETAMINOPHEN 500MG", "MEMBERS MARK ARTHRITIS PAIN", "MEJORALITO CHILDREN", "LIL DRUG STORE CHILDRENS PAIN AND FEVER", "KIDS PAIN AND FEVER", "BASIC CARE ACETAMINOPHEN", "ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER", "PAIN AND FEVER CHILDRENS", "REGULAR STRENGTH ACETAMINOPHEN", "EQUALINE ACETAMINOPHEN", "PANADOL", "CHILDRENS PAIN RELIEVER AND FEVER REDUCER GRAPE", "LLORENS CARE CHILDREN ACETAMINOPHEN", "LEADER CHILDRENS PAIN AND FEVER", "INFANTS TYLENOL", "VICKS PAINQUIL LIQUICAPS PAIN RELIEVER", "GERICARE LIQUID PAIN RELIEF", "NITE-TIME COLD/FLU MEDICINE CHERRY", "AUROPHEN REGULAR STRENGTH", "FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574", "REXALL PAIN RELIEF", "MEIJER CHILDRENS PAIN AND FEVER REDUCER", "EIGHT HOUR PAIN RELIEF", "DOLO-NEUROBION", "CHILDRENS PAIN AND FEVER DISSOLVE PACKS", "MOMMYS BLISS INFANTS PAIN AND FEVER", "8HR ARTHRITIS PAIN", "GOOD NEIGHBOR PHARMACY CHILDRENS PAIN AND FEVER", "REGULAR STRENGTH PAIN RELIEF", "MIDOL LONG LASTING RELIEF", "PAIN RELIEVER CHILDRENS", "8 HR ARTHRITIS PAIN", "KIRKLAND SIGNATURE ACETAMINOPHEN ADULT EXTRA STRENGTH", "ACETAMINOPHEN GELCAPS", "WALGREENCHILDRENS PAIN FEVER", "COUNTERACT PAIN", "KROGER CHILDREN PAIN PLUS FEVER CHEWABLES", "FEVERALL", "DRX CHOICE REGULAR STRENGTH", "ACETAMINOPHEN EXTENDED-RELEASE", "GOOD SENSE CHILDRENS PAIN AND FEVER", "NOTTS - EXTRA STRENGTH 500 MG", "ROBITUSSIN DIRECT SORE THROAT PAIN", "TOPCARE 8 HOUR PAIN RELIEF", "ARTHRITIS PAIN", "CHEWABLE ACETAMINOPHEN CHILDRENS", "ACETAMINOPHEN CAPLETS", "TEMP X", "MEJORALITO", "FEVERALL CHILDRENS", "FEVER REDUCING CHILDRENS", "JUNIOR ACETAMINOPHEN AGES 6-11", "GENEXA ACETAMINOPHEN PM EXTRA STRENGTH", "CAREALL ACETAMINOPHEN EXTRA STRENGTH", "CHILDREN PAIN AND FEVER RELIVER", "GREEN GUARD MAXIMUM NON-ASPIRIN", "CETAFEN EXTRA", "CHILDRENS ACETAMINOPHEN ORAL LIQUID GRAPE FLAVOR", "PAIN RELIEF CHILDRENS DYE FREE", "MEJORALITO CHILDREN CHILDREN", "DR. SANA PAIN AND FEVER FOR CHILDREN", "CAREONE INFANTS ACETAMINOPHEN", "MEDIQUE APAP", "MEDI-FIRST NON-ASPIRIN", "MEDI-FIRST PLUS NON-ASPIRIN", "DOVER AMINOFEN", "DOVER AMINOPHEN", "MEDI FIRST PLUS NON-ASPIRIN", "EQUALINE CHILDRENS ACETAMINOPHEN", "GOOD SENSE PAIN RELIEF ARTHRITIS PAIN", "UP AND UP CHILDRENS ACETAMINOPHEN", "MAJOR EXTRA STRENGTH ACETAMINOPHEN LIQUID", "UP AND UP INFANTS ACETAMINOPHEN", "ACETAMINOPHEN GELCAPS EXTRA STRENGTH", "CAREONE CHILDRENS ACETAMINOPHEN", "GENEXA KIDS PAIN AND FEVER", "FOSTER AND THRIVE CHILDRENS PAIN AND FEVER", "ACETAMINOPHEN 325 MG", "CHILDREN ACETAMINOPHEN", "365 WHOLE FOODS MARKET ACETAMINOPHEN", "CAREONE 8 HOUR PAIN RELIEF", "PAIN AND FEVER CHEWABLES CHILDRENS", "NOTTS - MUSCLE ACHES AND PAIN", "CIRCLE K PAIN RELIEVER EXTRA STRENGTH", "EXTRA STRENGTH PAIN RELEIF", "ACETAMINOPHEN SOLUTION", "NEO-LUBRINA CHILDREN", "LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER", "PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH", "EQUATE PAIN AND FEVER CHILDRENS", "PAIN RELIEVER FEVER REDUCER CHILDRENS", "ACETAMINOPHEN (RED)", "CHILDRENS PAIN AND FEVER, GRAPE FLAVOR", "DESENFRIOL-ITO PLUS", "TYLENOL 8HR", "CHILDRENS ACETAMINOPHEN ORAL SUSPENSION", "DURALGINA", "MAJOR ACETAMINOPHEN", "MOMMYS BLISS CHILDRENS PAIN AND FEVER", "DG HEALTH PAIN RELIEF", "CHILDRENS FEVER REDUCER AND PAIN RELIEVER", "LIQUID ACETAMINOPHEN", "GENEXA INFANTS PAIN AND FEVER", "TYLENOL EXTRA STRENGTH, TRAVEL BASIX", "TYLENOL EXTRA STRENGTH, CVP HEALTH", "PHARBETOL", "8HR ARTHRITIS PAIN RELIEF", "SIGNATURE CARE PAIN RELIEF", "PARRY-500MG ACETAMINOPHEN", "ACETAMINOPHEN 650MG", "PAIN RELIEF EXTRA STRENGTH, NON-ASPIRIN", "CHILDRENS PAIN AND FEVER CHERRY FLAVOR", "GOOD SENSE PAIN AND FEVER INFANTS", "RUGBY INFANTS ACETAMINOPHEN", "PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH", "8HR PAIN RELIEF", "DOLO - NEUROBION ACETAMINOPHEN MAX EXTENDED-RELEASE 650 MG", "PARENTS CHOICE INFANTS PAIN AND FEVER", "VICKS PAINQUIL PAIN RELIEVER", "FEVERALL JR. STRENGTH", "DR KIDS PAIN AND FEVER", "DG HEALTH 8 HOUR PAIN RELIEF", "AUROPHEN EXTRA STRENGTH FOR ADULTS", "CAREALL NON ASPIRIN EXTRA STRENGTH", "EXTRA STRENGTH MINI SOFTGELS PAIN RELIEVER", "MEDI-FIRST EXTRA STRENGTH NON ASPIRIN", "MEDI-FIRST PLUS EXTRA STRENGTH NON ASPIRIN", "MEMBERS MARK ACETAMINOPHEN", "ONESSIP ACETAMINOPHEN", "GOOD SENSE PAIN AND FEVER", "SAFETYNADOL", "CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER", "MAX RELIEF JUNIOR", "EQUATE PAIN RELIEF", "LEADER ACETAMINOPHEN", "RAPIDOL", "FEVERALL INFANTS", "ATAMEL FORTE", "KOSHER MEDS CHILDRENS PAIN AND FEVER", "EXTRA STRENGTH NO-PAIN", "MUSCLE ACHES AND PAINS ACETAMINOPHEN EXTENDED RELEASE", "GREEN GUARD MAXIMUM STRENGTH NON-ASPIRIN", "TEMPERAL-ITO", "EXCEDRIN RAPID RELIEF", "PUREGEN LABS ACETAMINOPHEN", "HENRY SCHEIN ACETAMINOPHEN", "8 HR PAIN RELIEF", "ED APAP", "INFANTS PAIN AND FEVER CHERRY FLAVOR", "PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH", "WELBY ACETAMINOPHEN", "MEDIQUE AT HOME APAP", "PAIN RELIEF 8 HR", "THOMPSON EXTRA STRENGTH NON-ASPIRIN", "CROCIN MAX", "ADWE CHILDRENS PAIN FEVER", "TOPCARE PAIN AND FEVER", "GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEF", "CHILDRENS CHEWABLES", "MCKESSON ACETAMINOPHEN 325", "CHILDRENS PAIN PLUS FEVER RELIEF", "RUGBY CHILDRENS ACETAMINOPHEN", "EQUATE INFANTS PAIN AND FEVER", "EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY", "FAST ACTING PEDIA CRAE", "DOLEX CHILDREN PAIN AND FEVER", "DIRECT SAFETY ASPIRIN FREE", "SIGNATURE CARE INFANTS PAIN RELIEF", "RUGBY REGULAR STRENGTH ACETAMINOPHEN", "WALGREEN CHILDRENS PAIN PLUS FEVER", "CHILDRENS ACETAMINOPHEN DYE FREE GRAPE", "CHILDRENS PAIN RELIEF AND FEVER REDUCER ORAL SUSPENSION CHERRY", "UNISHIELD EXTRA STRENGTH NON-ASPIRIN", "UNISHIELD EXTRA STRENGTH NON ASPIRIN", "GENEXA CHILDRENS ACETAMINOPHEN", "RIGHT REMEDIES PAIN RELIEF EXTRA STRENGTH CAPLET", "DG HEALTH 8 HR ARTHRITIS PAIN RELIEF", "VITAPIRENA", "PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH", "GOODNOW PAIN RELIEF", "GOOD SENSE INFANTS PAIN AND FEVER", "GOOD NEIGHBOR PHARMACY PAIN AND FEVER CHILDRENS", "EQUATE MENSTRUAL PAIN RELIEF", "LEADER 8HR ARTHRITIS PAIN RELIEF", "MAPAP EXTRA STRENGTH", "MANTRA PAIN GEL RASPBERRY", "RINGL", "BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER", "DYE FREE PAIN AND FEVER CHILDRENS", "RAPID RELEASE PAIN RELIEF", "NON-ASPIRIN CHILDRENS", "APHEN", "CHILDREN PAIN AND FEVER RELIEVER", "CHILDRENS PAIN RELIEVER AND FEVER REDUCER CHERRY", "DR. COCOA FOR CHILDREN PAIN AND FEVER", "KINDERFARMS CHILDRENS PAIN AND FEVER", "GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN", "CETAFEN", "ARTHRITIS PAIN ACETAMINOPHEN", "BERKLEY AND JENSEN PAIN RELIEF", "PHARBETOL REGULAR STRENGTH", "BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN", "XPECT ACETAMINOPHEN", "TYLENOL EXTRA STRENGTH CAPLET", "DYE FREEINFANTS PAIN AND FEVER", "EQUATE CHILDRENS PAIN AND FEVER", "CAREONE ACETAMINOPHEN", "ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH", "CHILDRENS MAPAP", "DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE", "8 HR ARTHRITIS PAIN RELIEF", "PAIN RELIEVER DYE FREE", "RESFRIOL-ITO CHILDREN", "FOSTER AND THRIVE RAPID RELEASE PAIN RELIEF", "ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG", "BERKLEY AND JENSEN ACETAMINOPHEN", "CHILDRENS PAIN AND FEVER DYE FREE", "8 HR MUSCLE ACHES AND PAIN", "8HR MUSCLE ACHES AND PAIN RELIEF", "NITE-TIME COLD/FLU MEDICINE", "DR SIMI PAIN RELIEF", "GESTEIRA", "CARE ONE ARTHRITIS PAIN RELIEF", "LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER" ], "generic_name": [ "ACETAMINOPHEN", "ACETAMINOPHEN 500MG", "ACETAMINOPHEN TABLET EXTENDED RELEASE", "PAIN RELIEVER" ], "manufacturer_name": [ "Amazon.com Services LLC", "Meijer, Inc.", "JHK Inc dba American Safety & First Aid", "H E B", "Sixarp, LLC", "PAI Holdings, LLC dba PAI Pharma", "HYVEE INC", "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "L.N.K. International, Inc.", "AMERISOURCE BERGEN", "WALMART INC. (see also Equate)", "Walgreen Company", "Kroger Company", "AptaPharma Inc.", "Topco Associates LLC", "Granules USA, Inc", "Advance Pharmaceutical Inc.", "Meijer Distribution Inc", "Strategic Sourcing Services LLC", "FAMILY DOLLAR SERVICES INC", "Kenvue Brands LLC", "Genexa Inc.", "WALGREENS", "LIDL US LLC", "Medline Industries, LP", "PUBLIX SUPERMARKETS, INC", "KROGER COMPANY", "Farmacias De Similares TX LLC", "Pinnacle RX LLC", "VALU MERCHANDISERS COMPANY", "HEB", "Magno-Humphries, Inc.", "Hi-Tech Nutraceuticals, LLC", "CVS PHARMACY", "New World Imports, Inc", "Chain Drug Marketing Association", "Cardinal Health 110, LLC. dba Leader", "Aurohealth LLC", "DISCOUNT DRUG MART", "United Natural Foods, Inc. dba UNFI", "American Health Packaging", "P & L Development, LLC", "GERI-CARE PHARMACEUTICAL CORP", "Major Pharmaceuticals", "TIME CAP LABORATORIES, INC", "Rite Aid Corporation", "Meijer", "Padagis Israel Pharmaceuticals Ltd", "LEADER/ Cardinal Health 110, Inc.", "Target Corporation", "Acetris Pharma Holdings, LLC", "Better Living Brands, LLC", "Valu Merchandisers Company", "Dolgencorp Inc", "Pharmadel LLC", "Softgel Healthcare Pvt Ltd", "Chain Drug Marketing Association, Inc.", "Dolgencorp, LLC", "Wal-Mart Stores Inc", "KinderFarms, LLC", "HyVee Inc", "HARRIS TEETER", "Amerisource Bergen", "MAJOR PHARMACEUTICALS", "GoodSense", "TOPCO ASSOCIATES LLC", "BLESSINGS INTERNATIONAL", "OPMX Chula Vista", "WinCo Foods, LLC", "COSTCO WHOLESALE CORPORATION", "Grocery Outlet, Inc.", "CVS Pharmacy", "BJWC (Berkley & Jensen / BJ's)", "Wildman Business Group", "WALMART INC.", "Dr. Reddy's Laboratories Inc.", "Bi-Mart", "Walgreens", "Allegiant Health", "TIME CAP LABORATORIES, INC.", "Athlete's Needs, Inc.", "Safeway", "ARMY AND AIR FORCE EXCHANGE SERVICE", "PUBLIX SUPER MARKETS INC", "MEIJER, INC.", "Cabinet Health P.B.C.", "Family Dollar, Inc.", "STRATEGIC SOURCING SERVICES LLC", "WAL-MART STORES INC", "Haleon US Holdings LLC", "WALGREEN CO.", "CVS HEALTH CORP", "CVS PHARMACY INC", "FSA STORE INC.", "Unifirst First Aid Corporation", "AAA Pharmaceutical, Inc.", "INGLES MARKETS, INC.", "L. Perrigo Company", "NUVICARE LLC", "Rnv LLC", "Shield Pharmaceuticals Corp", "CVS Pharmacy, Inc.", "Geri-Care Pharmaceutical Corp", "Strategic Sourcing Services, LLC", "Granules USA, Inc.", "Richmond Pharmaceuticals, Inc.", "Granules Pharmaceuticals Inc.", "MARC GLASSMAN, INC.", "Walmart Inc", "Method Pharmaceuticals, LLC", "Publix Super Markets Inc", "CVS PHARMACY, INC.", "Marlex Pharmaceuticals Inc", "Harris Teeter", "Menper Distributors, Inc.", "Safeway, Inc.", "Uline", "Ellywell, LLC", "DLC Laboratories, Inc.", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "BENARD INDUSTRIES INC", "Camber Pharmaceuticals, Inc.", "WALMART INC", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Sam's West Inc", "OPMX LLC", "Lil' Drug Store Products, Inc.", "CARDINAL HEALTH", "DOLGENCORP, LLC", "SAFEWAY", "Rising Pharma Holdings, Inc.", "DeMoulas Market Basket", "Salado Sales, Inc.", "Llorens Pharmaceutical International Division, Inc.", "Topco Associates, LLC", "The Procter & Gamble Manufacturing Company", "CVS PHARMACY, INC", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services, Inc.", "MEIJER DISTRIBUTION INC", "TIME CAP LABS INC", "WALGREENS CO.", "Mom Enterprises, LLC.", "Mylan Institutional LLC", "Reliable 1 Laboratories LLC", "Belmora LLC", "Bayer HealthCare LLC.", "Sagent Pharmaceuticals", "Costco Wholesale Company", "Caplin Steriles Limited", "WALGREEN COMPANY", "Family Dollar (FAMILY WELLNESS)", "Civica, Inc.", "AMERICAN SALES COMPANY", "TARGET CORPORATION", "Demoulas Super Markets, Inc", "Oncor Pharmaceuticals", "Melaleuca, Inc.", "Sun Pharmaceutical Industries, Inc.", "Raritan Pharmaceuticals Inc.", "FOODHOLD U.S.A., LLC", "VIVUNT PHARMA LLC", "Baxter Healthcare Corporation", "SAM'S WEST INC", "Sandoz Inc", "Cardinal Health 110, LLC. DBA Leader", "Breeden Brothers, LLC", "B. Braun Medical Inc.", "Family Dollar Services Inc", "MEIJER", "QUALITY CHOICE (Chain Drug Marketing Association)", "Chain Drug Consortium", "AARNA USA INC.", "HART Health", "GADAL Laboratories, Inc", "CVS PHARMACY iNC", "CHAIN DRUG MARKETING ASSOCIATION INC", "Rugby Laboratories", "Retail Business Services, LLC", "Discount Drug Mart", "Kroger", "AMERIFOODS TRADING COMPANY", "WG Critical Care, LLC", "American Sales Company", "Genexa, Inc.", "Pioneer Life Sciences, LLC", "Whole Foods Market, INC.", "Shield Pharmaceuticals Corp.", "Solupharm Pharmazeutische Erzeugnisse GmbH", "Walmart", "Marc Glassman, Inc.", "Orelli Inc.", "Patrin Pharma, Inc.", "CHAIN DRUG CONSORTIUM", "BETTER LIVING BRANDS LLC.", "Medtech Products Inc.", "Acme United Corporation", "PuraCap Pharmaceutical LLC", "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Menper Distributors Inc.", "RITE AID", "Granules India Limited", "RETAIL BUSINESS SERVICES , LLC.", "Walmart Inc.", "Prostat First Aid", "Hikma Pharmaceuticals USA Inc.", "LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION", "BluePoint Laboratories", "LEADER/ Cardinal Health 110, Inc", "Family Dollar Stores, LLC", "Pharbest Pharmaceuticals, Inc.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Velocity Pharma LLC", "Better Living Brands LLC", "MDC PHARMACEUTICALS LIMITED", "Forreal Pharmaceuticals, LLC", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "CalmCo LLC", "Best Choice (Valu Merchandisers Company)", "Meijer Distribution, Inc.", "TopCo Associates LLC", "BETTER LIVING BRANDS, LLC", "MEDWISE LIFESCIENCES INC.", "Westminster Pharmaceuticals, LLC", "Sinew Pharma Inc.", "FSA Store Inc.", "Genomma Lab USA, Inc.", "Akron Pharma Inc.", "Mollec Inc", "Safrel Pharmaceuticals, LLC.", "Advanced Rx LLC", "Henry Schein, Inc.", "Health Pharma USA LLC", "DOLGENCORP, INC.", "EDWARDS PHARMACEUTICALS, INC.", "FAMILY DOLLAR", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Aldi, Inc", "Fresenius Kabi USA, LLC", "Thompson", "CVS Pharmacy,Inc.", "RARITAN PHARMACEUTICALS INC", "McKesson Medical-Surgical, Inc.", "CVS Pharmacy, Inc", "Randob Labs., Ltd.", "Conney Safety Products, LLC", "RUGBY LABORATORIES", "FSA Store Inc. (Caring Mills)", "Puro Pharma Inc.", "THE KROGER CO", "Unishield", "Strive Pharmaceuticals Inc.", "RAONBIO CORP", "Trifecta Pharmaceuticals USA LLC", "Gobrands, Inc", "CVS", "MOREMED INC.", "RETAIL BUSINESS SERVICES,LLC.", "Sato Pharmaceutical Co., Ltd.", "BETTER LIVING BRANDS LLC", "WINCO FOODS, LLC", "Asclemed USA, Inc.", "Infirst Healthcare Inc.", "McKesson", "BJWC", "AmeriSource Bergen", "Cintas Corporation", "Jones Healthcare Group - Packaging Services, Inc", "Aurex Laboratories Limited Liability Company", "HHH Pharmaceuticals", "Advagen Pharma Limited", "MARKSANS PHARMA LIMITED", "UNFI", "Gland Pharma Limited", "Eugia US LLC" ], "product_ndc": [ "72288-405", "79481-0302", "73598-1122", "73598-1124", "59640-766", "59368-210", "0121-2094", "42507-404", "52412-906", "50844-519", "46122-629", "79903-172", "0363-1502", "30142-561", "76281-526", "36800-202", "69848-008", "36800-455", "17714-013", "41250-148", "70677-1138", "55319-206", "50580-579", "69676-0059", "0363-9781", 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Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ESTRADIOL", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "ESTRADIOL" }, "openfda": { "application_number": [ "NDA020538", "ANDA217882", "ANDA206241", "NDA020908", "ANDA075182", "NDA020375", "ANDA205256", "ANDA210264", "ANDA217610", "ANDA212313", "ANDA210194", "ANDA206685", "ANDA086069", "ANDA216524", "NDA203752", "ANDA211783", "ANDA216055", "ANDA211396", "NDA021166", "ANDA216160", "ANDA217334", "ANDA040275", "ANDA216550", "ANDA218507", "ANDA211293", "NDA020472", "NDA022014", "ANDA218214", "NDA021813", "ANDA202985", "ANDA209767", "NDA022038", "ANDA040197", "ANDA201675", "ANDA206388", "ANDA204379", "ANDA208788" ], "brand_name": [ "VIVELLE-DOT", "ESTRADIOL", "VAGIFEM", "MENOSTAR", "YUVAFEM", "ESTRADIOL VAGINAL INSERTS", "ESTRADIOL VAGINAL CREAM", "ESTRADIOL VAGINAL", 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"SLEEP-AID DIPHENHYDRAMINE HCL", "NIGHTTIME SLEEP-AID SOFTGEL", "CIRCLE K ALLERGY ANTIHISTAMINE", "EQUATE ALLERGY RELIEF", "CVS DYE-FREE CHILDRENS ALLERGY", "WAL DRYL CHILDRENS ALLERGY", "VICKS ZZZQUIL FREE AND CLEAR NIGHTTIME SLEEP-AID", "LEADER NIGHTTIME SLEEP-AID", "CHILDRENS ALLERGY RELIEF DYE FREE BUBBLE GUM", "NYT TIME SLEEP CAPS", "VICKS ZZZQUIL NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCL FREE OF", "VALUMEDS ALLERGY RELIEF ANTIHISTAMINE DIPHENHYDRAMINE HCL", "BENADRYL ALLERGY LIQUI-GELS", "BENADRYL ALLERGY EXTRA STRENGTH LIQUI-GELS", "BENADRYL EXTRA STRENGTH ITCH STOPPING", "BETR SLEEP AID", "DYE FREE WAL SLEEP Z", "NIGHTTIME SLEEPAID", "SLEEP AID NIGHTTIME", "QUALITY CHOICE NIGHTTIME SLEEP-AID", "DIPHENHYDRAMINE", "HARRIS TEETER ALLERGY RELIEF", "ZZZQUIL NIGHTTIME SLEEP-AID", "GOOD NEIGHBOR ALLERGY RELIEF", "EQUATE NIGHTTIME SLEEP-AID", "QUALITY CHOICE ALLERGY RELIEF", "WALGREEN ITCH RELIEF GEL", "TARGET DYE FREE CHILDRENS ALLERGY RELIEF", "SLEEPAID SOFTGELS", "FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF", "DORMMY-LON", "KROGER ALLERGY RELIEF", "GOOD SENSE ALLERGY RELIEF", "NIGHTTIME SLEEP AID MAXIMUM STRENGTH", "VICKS NYQUIL KIDS FREE OF ARTIFICIAL DYES AND SUGAR COLD AND COUGH PLUS RUNNY NOSE", "GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY", "NIGHTTIME SLEEP-AID", "EQUATE NIGHTTIME SLEEP AID", "CHILDRENS BENADRYL CHEWABLES", "GOODMEDS ALLERGY RELIEF DIPHENHYDRAMINE HCL", "MEIJER NIGHTTIME SLEEP AID CAPLET", "NIGHTIME SLEEP AID", "GOOD REMEDIES ALLERGY RELIEF SOFTGEL", "CVS DIPHENHYDRAMINE HYDROCHLORIDE", "DG HEALTH ALLERGY CHILDRENS", "WINCO FOODS CHILDRENS ALLERGY RELIEF DYE FREE", "ALLERGY RELIEF DIPHENHYDRAMINE HCL 25MG SOFTGEL", "DYE FREE ALLERGY CHILDRENS", "RIGHT REMEDIES ALLERGY RELIEF", "BERKLEY AND JENSEN ALLERGY RELIEF", "ADWE DYE-FREE CHILDRENS ALLERGY", "BENADRYL ALLERGY ULTRATAB", "RIGHT REMEDIES MAXIMUM STRENGTH NIGHTTIME SLEEP-AID SOFTGEL", "TOPCARE CHILDRENS ALLERGY", "SOMINEX", "QUALITY CHOICE CHILDRENS ALLERGY RELIEF DYE FREE", "INSTARELIEF NIGHTTIME SLEEP AID", "DISCOUNT DRUGMART ALLERGY RELIEF", "JET-ASLEEP DOUBLE STRENGTH NIGHT TIME SLEEP AID", "ALLERGY RELIEF CAPLET", "M-DRYL", "BENADRYL ALLERGY EXTRA STRENGTH", "MEIJER NIGHTTIME SLEEP AID SOFTGEL", "DIMETANE", "CHILDRENS ALLERGY DYE FREE WAL DRYL", "XPECT EXTRA STRENGTH ITCH RELIEF", "ALLERGY RELIEF DYE-FREE SOFTGEL", "TECNU CALAGEL", "KROGER DYE FREE CHILDRENS ALLERGY RELIEF", "DYE FREE WAL DRYL ALLERGY CHILDRENS", "CABINET ALLERGY RELIEF REFILL DIPHENHYDRAMINE HCI", "CHILDRENS BENADRYL DYE-FREE ALLERGY", "CHILDRENS DYE FREE ALLERGY", "BACTIMICINA CHILDRENS ALLERGY", "KROGER NIGHTTIME SLEEP AID CAPLET", "SOMNITABS", "RITE AID NIGHTTIME SLEEP AID NON HABIT FORMING", "KROGER NIGHTTIME SLEEP-AID", "ALLERGY RELIEF DIPHENHYDRAMINE HCL", "CHILDRENS BENADRYL ALLERGY" ], "generic_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE", "DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED" ], "manufacturer_name": [ "Target Corporation", "Epic Pharma, LLC", "QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)", "Meijer Distribution Inc", "Discount Drug Mart", "DISCOUNT DRUG MART", "Lil' Drug Store Products, Inc.", "Chain Drug Marketing Association", "VIVUNT PHARMA LLC", "Topco Associates LLC", "Cabinet Health P.B.C.", "American Health Packaging", "KinderFarms, LLC", "TIME CAP LABORATORIES, INC", "Unifirst First Aid Corporation", "WALGREENS", "Prodose, Inc.", "CVS Pharmacy,Inc.", "CVS Pharmacy, Inc", "MEIJER DISTRIBUTION INC", "American Sales Company", "TopCo Associates LLC", "Natco Pharma USA LLC", "Strive Pharmaceuticals Inc.", "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "Kenvue Brands LLC", "Softgel Healthcare Pvt Ltd", "HYVEE INC", "United Natural Foods, Inc. dba UNFI", "PUBLIX SUPER MARKETS INC", "TOPCO ASSOCIATES LLC", "Marc Glassman, Inc.", "Shield Pharmaceuticals Corp", "KROGER COMPANY", "H E B", "TARGET CORPORATION", "Foundation Consumer Healthcare", "PAI Holdings, LLC dba PAI Pharma", "WALGREEN COMPANY", "Walgreen Company", "Major Pharmaceuticals", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "WAL-MART STORES INC.", "Walgreens", "CVS Pharmacy, Inc.", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Advance Pharmaceutical Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Amerisource Bergen", "DeMoulas Market Basket", "Meijer, Inc.", "HEB", "Chain Drug Consortium", "VALU MERCHANDISERS COMPANY", "Hikma Pharmaceuticals USA Inc.", "Dolgencorp Inc", "Walmart Inc.", "Cabinet Health, Inc", "Aldi Inc", "FOODHOLD U.S.A., LLC", "New World Imports, Inc", "L. Perrigo Company", "Armas Pharmaceuticals Inc.", "Safeway, Inc.", "Rising Pharma Holdings, Inc.", "Wal-Mart Stores Inc", "Velocity Pharma LLC", "Force Factor Brands LLC", "Vivunt Pharma LLC", "The Procter & Gamble Manufacturing Company", "Raritan Pharmaceuticals Inc", "Safetec of America, Inc.", "Sagent Pharmaceuticals", "Amazon.com Services LLC", "P & L Development, LLC", "Oncor Pharmaceuticals", "Cardinal Health 110, LLC. DBA Leader", "CVS PHARMACY, INC", "CVS PHARMACY", "SOFTGEL HEALTHCARE PRIVATE LIMITED", "AMZ789 LLC", "CARDINAL HEALTH", "FSA Store Inc. (Caring Mills)", "Richmond Pharmaceuticals, Inc.", "BJWC (Berkley & Jensen / BJ's)", "Simpex Pharma Pvt. Ltd", "AMERIFOODS TRADING COMPANY", "Fresenius Kabi USA, LLC", "Live Betr LLC", "WALGREEN CO.", "Company name: Topco Associates, LLC", "Chain Drug Marketing Association, Inc.", "Harris Teeter", "AAA Pharmaceutical, Inc.", "AmerisourceBergen Drug Corp", "WALMART INC.", "Chattem, Inc.", "RETAIL BUSINESS SERVICES , LLC.", "Kroger Company", "PIONEER LIFE SCIENCES, LLC", "LEADER/ Cardinal Health 110, Inc.", "Camber Pharmaceuticals, Inc.", "Strategic Sourcing Services LLC", "Haendel Farma, S.A. de C.V.", "THE KROGER CO", "Micro Labs Limited", "Best Choice (Valu Merchandisers Company)", "Grocery Outlet, Inc.", "BETTER LIVING BRANDS LLC.", "Bi-Mart", "Health Pharma USA LLC", "CVS Pharmacy", "Dolgencorp, LLC", "WINCO FOODS, LLC", "Pioneer Life Sciences, LLC", "QUALITY CHOICE (Chain Drug Marketing Association)", "Demoulas Super Markets, Inc", "Strive Pharmaceuticals Inc", "BJWC", "RARITAN PHARMACEUTICALS INC", "Jones Healthcare Group - Packaging Services, Inc", "Richmond Pharmaceuticals Inc.", "Avenacy, LLC", "FSA STORE INC.", "Time-Cap Labs, Inc", "DOLGENCORP, LLC", "Medtech Products Inc.", "DXM Pharmacuetical, Inc.", "Gland Pharma Limited", "Discount Drug Mart, Inc", "Bell Pharmaceuticals, Inc.", "Method Pharmaceuticals, LLC", "AptaPharma Inc.", "NUVICARE LLC", "Cintas Corporation", "Tec Laboratories Inc.", "Redmont Pharmaceuticals, LLC", "SAM'S WEST INC", "Strategic Sourcing Services, LLC", "Publix Super Markets Inc", "DLC Laboratories, Inc.", "The Kroger Co.", "HARRIS TEETER", "RITE AID CORPORATION", "TWIN MED LLC" ], "product_ndc": [ "11673-186", "42806-649", "83324-336", "41250-379", "53943-505", "53943-191", "66715-6406", "66715-9706", "66715-6506", "63868-492", "82706-019", "76162-438", "82725-4201", "60687-829", "82673-109", "49483-061", "63868-087", "47682-167", "47682-184", "0363-0100", "68210-4160", "59779-793", "51316-835", "41250-853", "41520-431", "36800-909", "69339-151", "69339-152", "70692-785", "53345-005", "50580-573", "35916-0470", "42507-290", 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ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW DOSE MINIPRIN ENTERIC SAFETY COATED", "ASPIRIN DELAYED RELEASE", "GOOD NEIGHBOR PHARMACY ASPIRIN", "LEADER ASPIRIN", "CHEWABLE LOW DOSE ASPIRIN", "CIRCLE K ASPIRIN 325", "LOW DOSE ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 81MG ENTERIC COATED", "CHILDRENS ASPIRIN", "CVS EFFERVESCENT PAIN RELIEVER", "BASIC CARE ASPIRIN", "SIGNATURE SELECT EFFERVESCENT PAIN RELIEF", "TRI-BUFFERED ASPIRIN", "ASPIRIN ENTERIC COATED, REGULAR STRENGTH", "ASPIRIN LOW DOSE CHEWABLE", "ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 325 MG", "MEDIQUE AT HOME ASPIRIN", "REGULAR STRENGTH ENTERIC COATED ASPIRIN", "DYE-FREE ASPIRIN 81", "PUBLIX FAST RELIEF EFFERVESCENT - ORIGINAL FLAVOR", "BEST CHOICE EFFERVESCENT PAIN RELIEVER 36", "ASPIRIN 81 MG", "BAYER ASPIRIN ORIGINAL, TRAVEL BASIX", "BAYER ASPIRIN ORIGINAL, CVP HEALTH", "BAYER", "QUALITY CHOICE EFFERVESCENT PAIN RELIEF", "MEDLINE", "ASPI-COR", "UNISHIELD ASPIRIN", "FAMILY WELLNESS PAIN RELIEVER", "ASPIRINA CAPLETS", "ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN", "EQUATE ASPIRIN CHEWABLE", "GOOD SENSE ASPIRIN", "BAYER ASPIRIN REGIMEN ENTERIC COATED", "RUGBY ASPIRIN", "ASPIRIN NSAID", "RIGHT REMEDIES LOW DOSE ASPIRIN 81MG", "ASPIRIN 50 CT", "SUNMARK ASPIRIN", "ASPIRIN PAIN RELIEF", "DIRECT SAFETY ASPIRIN", "ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE", "FIRST AID DIRECT CHEWABLE ASPIRIN", "FOSTER AND THRIVE ASPIRIN", "ENTERIC COATED ASPIRIN REGULAR STRENGTH", "LIL DRUG STORE ASPIRIN 325", "DOLLAR GENERAL EFFERVESCENT PAIN RELIEVER", "ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN LOW DOSE CHEWABLE ORANGE", "ADULT LOW DOSE PAIN RELIEVER", "ASPIRIN PAIN RELIVER", "DG HEALTH ASPIRIN", "LOW DOSE CHEWABLE ASPIRIN", "ASPIRIN REGIMEN", "GREEN GUARD CHEWABLE ASPIRIN 81 MG", "ECOTRIN REGULAR STRENGTH", "GENCARE-ASPIRIN LOW DOSE PAIN RELIEVER (NSAID)", "ASPIRIN LOW DOSE ENTERIC COATED", "PHYSICIANS CARE ASPIRIN", "ASPIRIN 325", "BAYER LOW DOSE", "MARKET BASKET EFFERVESCENT PAIN RELIEF", "BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE", "WINCO FOODS EFFERVESCENT PAIN RELIEF", "MEIJER LOW DOSE ASPIRIN", "ASPIRIN LOW STRENGTH", "LOW STRENGTH CHEWABLE ASPIRIN", "MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN", "PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN 81MG ADULT LOW DOSE", "ECOTRIN", "EXTRA STRENGTH ASPIRIN", "LOW DOSE ASPIRIN 81MG", "NOBLEAID PAIN RELIEVER", "COATED ASPIRIN", "TOPCARE EFFERVESCENT PAIN RELIEF", "ASPIRIN 325 MG EC", "XPECT CHEWABLE ASPIRIN", "MCKESSON ASPIRIN", "GOOD SENSE EFFERVESCENT PAIN RELIEF", "MEIJER EFFERVESCENT PAIN RELIEF", "ASPIRIN CHEWABLE", "PAIN RELIEF ASPIRIN", "UP AND UP CHEWABLE ASPIRIN", "REGULAR STRENGTH ASPIRIN 325 MG", "ST. JOSEPH LOW DOSE ASPIRIN", "CARDIASPIRIN PROTECT", "ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN", "MEDIQUE PRODUCTS ASPIRIN", "MEDI-FIRST ASPIRIN", "MEDI-FIRST PLUS ASPIRIN", "EQUALINE EFFERVESCENT PAIN RELIEVER", "ASPIRIN ENTERIC COATED LOW DOSE", "ADULT LOW STRENGTH ASPIRIN", "THOMPSON ASPIRIN", "LOW DOSE ASPIRIUN", "ULINE ASPIRIN" ], "generic_name": [ "ASPIRIN", "ASPIRIN 81 MG", "ASPIRIN 325 MG" ], "manufacturer_name": [ "Unifirst First Aid Corporation", "Health Pharma USA LLC", "Topco Associates, LLC", "Walgreen Company", "CHAIN DRUG MARKETING ASSOCIATION INC", "Advanced Rx LLC", "H E B", "Chain Drug Marketing Association, Inc.", "Discount Drug Mart Inc", "STRATEGIC SOURCING SERVICES LLC", "L.N.K. International, Inc.", "Grocery Outlet", "Rising Pharma Holdings, Inc.", "HARRIS TEETER", "BETTER LIVING BRANDS LLC.", "Bi-Mart", "Trifecta Pharmaceuticals USA LLC", "Marc Glassman, Inc.", "Care One (Retail Business Services, LLC.)", "Geritrex LLC", "Cardinal Health 110, LLC. DBA Leader", "DISCOUNT DRUG MART", "Genomma Lab USA", "Wisdrug AG", "Wal-Mart Stores Inc", "Advance Pharmaceutical Inc.", "P & L Development, LLC", "H. E. BUTT GROCERY COMPANY", "Rite Aid Corporation", "Richmond Pharmaceuticals, Inc.", "Valu Merchandisers Company", "Magno-Humphries, Inc.", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Time-Cap Labs, Inc", "Bayer HealthCare LLC.", "Allegiant Health", "Amerisource Bergen", "Bellegrove Medical Supply, Inc.", "Padagis US LLC", "United Natural Foods, Inc. dba UNFI", "PROSTAT FIRST AID", "HYVEE INC", "Topco Associates LLC", "COSTCO WHOLESALE CORPORATION", "Geri-Care Pharmaceutical Corp", "Pharmadel LLC", "Better Living Brands LLC", "New World Imports, Inc", "MAJOR PHARMACEUTICALS", "Publix Super Markets Inc", "CARDINAL HEALTH, INC.", "FOODHOLD U.S.A., LLC", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "VALU MERCHANDISERS COMPANY", "Geiss, Destin & Dunn Inc.", "MARC GLASSMAN, INC.", "Cardinal Health 110, LLC. dba Leader", "ARMY AND AIR FORCE EXCHANGE SERVICE", "TARGET CORPORATION", "Meijer Distribution, Inc.", "RMT HEALTH LLC", "Lil Drug Store Products, Inc", "DOLGENCORP, LLC", "Cardinal Health 107, LLC", "HART Health", "CVS PHARMACY", "Amazon.com Services LLC", "Safeway Inc.", "AAA Pharmaceutical, Inc.", "Major Pharmaceuticals", "Better Living Brands, LLC", "Publix Supermarkets, Inc.", "Hi-Tech Nutraceuticals, LLC", "WALGREENS", "PUBLIX SUPER MARKETS INC.", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Lil' Drug Store Products, Inc.", "RETAIL BUSINESS SERVICES , LLC.", "SAM'S WEST INC", "BJWC (Berkley & Jensen / BJ's)", "Medline Industries, LP", "Unishield", "Chain Drug Marketing Association", "Lidl US LLC", "Akron Pharma Inc.", "FAMILY WELLNESS SERVICES, INC.", "Kroger Company", "Topco Associates", "CVS Pharmacy", "L. Perrigo Company", "Rugby Laboratories", "Gendose Pharmaceuticals, LLC", "Hy-Vee", "Reliable 1 Laboratories LLC", "TOP CARE (Topco Associates LLC)", "TIME CAP LABORATORIES, INC", "Strive Pharmaceuticals Inc.", "HyVee Inc", "Strategic Sourcing Services LLC", "BETTER LIVING BRANDS, LLC", "JHK Inc dba American Safety & First Aid", "Meijer", "Direct Safety", "Salado Sales, Inc.", "Cintas Corp", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services Inc", "Dolgencorp, Inc", "Pinnacle RX LLC", "GOODSENSE", "Health Pharma USA, LLC", "TWIN MED LLC", "Pioneer Life Sciences, LLC", "Meijer Distribution Inc", "Dolgencorp, LLC", "Marlex Pharmaceuticals Inc.", "Sam's West Inc", "WinCo Foods, LLC", "Unifirst First Aid Corporaiton", "Safeway", "Medtech Products Inc.", "Lodaat LLC", "Acme United Corporation", "McKesson Medical-Surgical, Inc.", "DEMOULAS SUPER MARKETS, INC.", "Winco Foods, LLC", "Meijer, Inc.", "Richmond Pharmaceuticals, Inc", "Famora Inc.", "PUBLIX SUPER MARKETS INC", "FSA STORE INC.", "Pharbest Pharmaceuticals, Inc.", "Discount Drug Mart", "Dr. Wayne's", "H-E-B", "TopCare", "HHH Pharmaceuticals", "Athlete's Needs Inc", "Noble Otc LLC", "TOPCO ASSOCIATES LLC", "Cintas Corporation", "McKesson Medical-Surgical", "AMERIFOODS TRADING COMPANY", "TIME CAP LABS INC", "Perrigo Direct, Inc.", "Walmart Inc.", "Target Corporation", "Kroger", "HEB", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "Foundation Consumer Healthcare", "Aarkish Pharmaceuticals NJ Inc.", "OPMX LLC", "Foundation Consumer Healthcare LLC", "INVAHEALTH INC", "UNITED NATURAL FOODS, INC. DBA UNFI", "NUVICARE LLC", "Thompson", "FSA Store Inc.", "ULINE", "Wildman Business Group" ], "product_ndc": [ "47682-456", "71679-302", "36800-545", "0363-0587", "63868-898", "80513-289", "37808-157", "83324-075", "53943-431", "70677-1121", "50844-600", "83324-058", "85828-372", "57237-302", "72036-252", "21130-428", "37835-571", "69396-173", "68998-146", "72476-263", "54162-940", "70000-0147", "53943-081", "50066-610", "87580-001", "49035-467", "17714-009", "59726-065", "37808-861", "70000-0253", "11822-0600", "54738-128", "63941-249", "54257-274", "83324-090", "49483-382", "0280-2090", "69168-318", "46122-691", "59961-616", "59961-620", "0574-7034", "17714-010", "41163-563", "58228-0071", "0363-0218", "42507-605", "36800-274", "57237-349", "63981-563", "57896-981", "55758-363", "21130-051", "51824-077", "0904-6783", "11822-6910", "56062-274", "17714-121", "70000-0014", "41520-157", "49035-563", "55910-765", "0280-2000", "49483-330", "49483-349", "63941-081", "24385-278", 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"Product used for unknown indication", "activesubstance": { "activesubstancename": "LIDOCAINE" }, "openfda": { "application_number": [ "505G(a)(3)", "M017", "M015", "ANDA088586", "ANDA216484", "ANDA040911", "ANDA206297", "ANDA206498", "ANDA200675", "M016", "ANDA088390", "ANDA088389", "ANDA211469", "ANDA086724", "ANDA210958", "ANDA205318", "ANDA217117", "NDA017584", "ANDA206463", "NDA020612", "ANDA080407", "NDA207962", "part348", "ANDA080198", "ANDA040433", "NDA215029", "ANDA211697", "M", "ANDA212695" ], "brand_name": [ "LIDOCAINE PAIN RELIEF GEL-PATCH", "BLACK COBRA TATTOO NUMBINGSPRAY 4% LIDOCAINE", "PAIN RELIEF", "AIPATCH NUMBING PAIN RELIEF", "INVIGOR OH", "UNIVERSAL PAIN RELIEF", "LIDOCAINE", "LIDOCAINE 5%", "STUD 100 MALE GENITAL DESENSITIZER", "DISCOUNT DRUG MART PAIN RELIEF PATCHES", "THERACARE LIDOCAINE PAIN RELIEF", "PAINLESS TATTOO 2", "DOLLAR GENERAL PAIN RELIEVING PATCH WITH LIDOCAINE", "VBBV NUMBING", "CORALITE ODOR FREE PAIN RELIEF", "PAIN RELIEF PATCHES", "KY DURATION 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NUMB", "RECTOPROTECT", "LIDOCORE", "CVS PAIN RELIEF", "LIDOXI", "LIDOCAINE 4% PATCH", "4 LIDOCAINE TOPICAL ANESTHETIC", "CURIST HEMORRHOID FISSURE RELIEF", "MAXIMUM STRENGTH 4% LIDOCAINE PATCH", "LIDOCAINE PATCH", "GNIBY LIDOCAINE ANORECTAL HEMORRHOIDAL NUMBING", "LMR PLUS", "CARELAND X-LARGE LIDOCAINE 4 PAIN RELIEVING", "MEIJER LIDOCAINE PAIN RELIEF PATCH ASSORTMENT SMALL", "GREENCAINE BLAST", "BIKINI ZONE MEDICATED GEL", "NUMB25", "NUMBING CREAM", "ADELLINA LIDOCAINE NUMBING CREAM ANORECTAL(HEMORRHOIDAL) CREAM", "GOODSENSE PAIN RELIEF", "ASPERCREME WITH LIDOCAINE ESSENTIAL OILS ROSEMARY MINT", "PAIN PATCH PERFECTO 24 HOURS LIDOCAINE 4 % PATCH", "MAXIMUM STRENGTH HEMORRHOIDAL RELIEF", "OCEAN POTION SUNCARE ICE PLUS PAIN RELIEVING SOOTHING", "BURN RELIEF", "NUMBING", "PUREGEN LABS PAIN RELIEF 4 LIDOCAINE", "WALGREENS LIDOCAINE KNEE AND ELBOW", "SIGNATURE CARE ALOE VERA GEL WITH LIDOCAINE", "LIDOCAINE PAIN RELIEVING GEL-PATCH", "PAIN RELIEVING", "LIDOCAINE PAIN RELIEF PATCH", "MYDERM", "ALIVIO", "OTC RESCUE LIDOCAINE PAIN RELIEF PATCH", "5% SIGNATURE NUMB CREAM", "NUMB AND NUMBER ANORECTAL CREAM", "FOOT AND LEG PAIN RELIEF", "MYDERM ALOE AND LIDOCAINE", "NUMB FAST HEMORRHOIDAL", "FLANAX BACK PAIN RELIEF", "MAXIMUM STRENGTH PAIN RELIEF LIDOCAINE PATCH", "RECTAEASE HEMORRHOID RELIEF CREAM", "CURIST LIDOCAINE MAXIMUM STRENGTH", "LMX4", "HONEST MED LIDOCAINE PAIN RELIEF PATCH", "BUNNIES BUM HEMORRHOIDAL NUMBING", "ADELLINA NUMBING CREAM", "VBBV ANORECTAL(HEMORRHOIDAL) CREAMS", "DESERT HARVEST RELEVEUM", "PLUM SMOOTH PLUMB NUMB GELEE", "SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX", "MEIJER LIDOCAINE PAIN RELIEF PATCH ASSORTMENT MEDIUM", "SYNTHERMA PLUS", "LIDOXRYL", "MYDERM MEDICAL 5 LIDOCAINE NUMBING ROLL-ON", "THERACARE PAIN RELIEF 4% LIDOCAINE", "PROLAYED", "THERA CARE PAIN THERAPY", "XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE", "THERACARE PAIN RELIEVING PATCH WITH LIDOCAINE", "ASPERCREME WITH LIDOCAINE DRY", "BIOFREEZE ULTRAFLEX", "PAIN RELIEF PATCH 4% LIDOCAINE", "VBBV TATTOO NUMBING", "LIDOCAINE KNEE PAIN RELIEF GEL-PATCH", "LIDOCAINE ANORECTAL", "ASSIELF NUMBING TOPICAL ANORECTAL", "MAXIMUM STRENGTH 4% LIDOCAINE PATCH GOOD NEIGHBOR PHARMACY", "GOOD NEIGHBOR PAIN RELIEF PATCH WITH LIDOCAINE 4%", "THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH", "BURN EASE COOLING", "LEADER BURN RELIEF", "PAIN RELIEF PATCH LIDOCAINE", "PAIN RELIEVEING GEL-PATCH", "THERACARE FLEXIBLE PAIN RELIEVING", "ASPERCREME WITH LIDOCAINE", "MEIJER LIDOCAINE PAIN RELIEF PATCH ASSORTMENT LARGE", "AMAZON BASICS PAIN RELIEF PATCH WITH 4% LIDOCAINE", "GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK", "ASSURED BIKINI SMOOTH CREAM", "BACTINE MAX LIDOCAINE ROLL-ON 2.5OZ", "BLOOP FISSURE HEALING ANORECTAL TOPICAL", "TATTOO NUMBING CREAM", "LIDOCAINE ROLL-ON", "ADELLINA LIDOCAINE NUMBING CREAM TOPICAL ANORECTAL CREAM", "HEALCOME LIDOCAINE NUMBING CREAM", "HEMPVANA ULTRA STRENGTH PAIN RELIEF - OVERNIGHT", "EJAGUARD", "EQUATE PAIN RELIEVING CREAM LIDOCAINE", "CARELAND KINESIOLOGY DUAL ACTION PAIN RELIEVING TAPE", "BACTINE MAX ANTIBIOTIC AND LIDOCAINE MAX PAIN RELIEF", "CARELAND LIDOCAINE PAIN RELIEVING", "JO FOR HIM PROLONGER WITH LIDOCAINE", "MEIJER LIDOCAINE PAIN RELIEF BACK AND LARGE AREAS", "WALGREENS SUNBURN RELIEF", "LIDOCAINE NUMBING CREAM", "CURIST LIDOCAINE PATCH MAXIMUM STRENGTH", "BURN", "CVS HEALTH XL LIDOCAINE PAIN RELIEF", "MEIJER PAIN RELIEF CREAM", "LIDOTRODE", "BLACK COBRA TATTOO NUMBING CREAM 4% LIDOCAINE", "PAIN RELIEF GEL-PATCH", "CVS PAIN-RELIEVING", "HUSH ANESTHETIC", "ALBERTSONS PAIN RELIEF PATCH", "RITE AID LIDOCAINE PATCH XLARGE", "BUNNIES BUM ANORECTAL NUMBING", "LIDOCAINE PAIN RELIEF PATCHES", "RELIEVE A PAIN", "PROSTAT FIRST AID BURN EASE, 0.9G", "WALGREENS LIDOCAINE BACK", "ZENSA", "PAIN AND ITCH RELIEF 4% LIDOCAINE", "MEDLOT PAIN RELIEF GEL PATCH", "QUALITY CHOICE LIDOCAINE PAIN RELIEF PATCH", "LIDOCAINE CREAM, 4%", "AUVON PAIN RELIEF ROLL-ON", "LIDOCAINE PAIN RELIEF PATCH 5 CT", "FAST FREEZE LIDOCAINE", "LMX5", "QUICK NUMB", "TYLENOL PRECISE PAIN RELIEVING LIDOCAINE 4%", "LEADER PAIN RELIEF PATCHES", "PAIN RELIEF GEL-ROLL ON", "PAIN FREE IV", "HEALTHWISE MAXIMUM PAIN RELIEF", "HEMAWAY", "HEMRID ANORECTAL CREAM", "HEMORRHOID PAIN RELIEF", "WELMATE LIDOCAINE PAIN RELIEVING PATCH", "DCSILY NUMBING CREAM", "SALONPAS LIDOCAINE PAIN RELIEVING", "CURIST HEMORRHOID RELIEF", "ARTHCAL 4% LIDOCAINE GEL PATCHES", "LIDOCAINE PAIN-RELIEVING PATCH", "LIDOCAINE 4 PERCENT", "ZTLIDO", "NUMB PLUS MAXIMUM STRENGTH ANORECTAL", "DR. SCHOLLS BLISTER PAIN RELIEF COMPLETE", "DR REAL NUMB TOPICAL ANORECTAL", "DR. CARE NUMBING CREAM", "FL BURN EASE, 0.9G", "CURIST LIDOCAINE NUMBING RELIEF", "FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL", "HEMPVANA ULTRA STRENGTH PAIN RELIEF", "WALGREENS EXTRA SMALL LIDOCAINE", "NEUROCAINE", "MEDINUMB", "THE SOLUTION 2.0", "CARELAND MAX STRENGTH LIDOCAINE 4 PAIN RELIEVING", "DEEVEEANT NUMB", "RWWXII DEEP NUMBING CREAM(ANORECTAL HEMORRHOIDAL CREAM)", "WALGREENS LIDOCAINE PAIN RELIEVING PATCH ASSORTED", "STEADY FREDDY", "XESSO REAR COMFORT GLIDE", "HEMPVANA MAXIMUM STRENGTH PAIN RELIEF TOPICAL ANESTHETIC", "CVS HEALTH LIDOCAINE PAIN-RELIEVING", "MEDLINE", "5% DR.CARE NUMB CREAM", "LIDOCAINE PAIN RELIEF PATCH 6 CT", "BONICAEASEX PAIN RELIEVING LIDOCAINE", "MAXIMUM STRENGTH HEMORRHOIDAL RELIEF WITH FINGER COTS", "TOPCARE PAIN RELIEF PATCHES", "RELIVYX PLUS", "BONDLIDO", "LIDO KING LIDOCAINE 4% PAIN RELIEVING GEL-PATCH", "BIKINI ZONE MEDICATED CREME", "MUSCLE AND JOINT CARE", "SUMIFUN LIDOCAINE PAIN RELIEF GEL-PATCH", "EQUATE HEMORRHOID 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"ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER", "PAIN AND FEVER CHILDRENS", "REGULAR STRENGTH ACETAMINOPHEN", "EQUALINE ACETAMINOPHEN", "PANADOL", "CHILDRENS PAIN RELIEVER AND FEVER REDUCER GRAPE", "LLORENS CARE CHILDREN ACETAMINOPHEN", "LEADER CHILDRENS PAIN AND FEVER", "INFANTS TYLENOL", "VICKS PAINQUIL LIQUICAPS PAIN RELIEVER", "GERICARE LIQUID PAIN RELIEF", "NITE-TIME COLD/FLU MEDICINE CHERRY", "AUROPHEN REGULAR STRENGTH", "FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574", "REXALL PAIN RELIEF", "MEIJER CHILDRENS PAIN AND FEVER REDUCER", "EIGHT HOUR PAIN RELIEF", "DOLO-NEUROBION", "CHILDRENS PAIN AND FEVER DISSOLVE PACKS", "MOMMYS BLISS INFANTS PAIN AND FEVER", "8HR ARTHRITIS PAIN", "GOOD NEIGHBOR PHARMACY CHILDRENS PAIN AND FEVER", "REGULAR STRENGTH PAIN RELIEF", "MIDOL LONG LASTING RELIEF", "PAIN RELIEVER CHILDRENS", "8 HR ARTHRITIS PAIN", "KIRKLAND SIGNATURE ACETAMINOPHEN ADULT EXTRA STRENGTH", "ACETAMINOPHEN GELCAPS", "WALGREENCHILDRENS PAIN FEVER", "COUNTERACT PAIN", "KROGER CHILDREN PAIN PLUS FEVER CHEWABLES", "FEVERALL", "DRX CHOICE REGULAR STRENGTH", "ACETAMINOPHEN EXTENDED-RELEASE", "GOOD SENSE CHILDRENS PAIN AND FEVER", "NOTTS - EXTRA STRENGTH 500 MG", "ROBITUSSIN DIRECT SORE THROAT PAIN", "TOPCARE 8 HOUR PAIN RELIEF", "ARTHRITIS PAIN", "CHEWABLE ACETAMINOPHEN CHILDRENS", "ACETAMINOPHEN CAPLETS", "TEMP X", "MEJORALITO", "FEVERALL CHILDRENS", "FEVER REDUCING CHILDRENS", "JUNIOR ACETAMINOPHEN AGES 6-11", "GENEXA ACETAMINOPHEN PM EXTRA STRENGTH", "CAREALL ACETAMINOPHEN EXTRA STRENGTH", "CHILDREN PAIN AND FEVER RELIVER", "GREEN GUARD MAXIMUM NON-ASPIRIN", "CETAFEN EXTRA", "CHILDRENS ACETAMINOPHEN ORAL LIQUID GRAPE FLAVOR", "PAIN RELIEF CHILDRENS DYE FREE", "MEJORALITO CHILDREN CHILDREN", "DR. SANA PAIN AND FEVER FOR CHILDREN", "CAREONE INFANTS ACETAMINOPHEN", "MEDIQUE APAP", "MEDI-FIRST NON-ASPIRIN", "MEDI-FIRST PLUS NON-ASPIRIN", "DOVER AMINOFEN", "DOVER AMINOPHEN", "MEDI FIRST PLUS NON-ASPIRIN", "EQUALINE CHILDRENS ACETAMINOPHEN", "GOOD SENSE PAIN RELIEF ARTHRITIS PAIN", "UP AND UP CHILDRENS ACETAMINOPHEN", "MAJOR EXTRA STRENGTH ACETAMINOPHEN LIQUID", "UP AND UP INFANTS ACETAMINOPHEN", "ACETAMINOPHEN GELCAPS EXTRA STRENGTH", "CAREONE CHILDRENS ACETAMINOPHEN", "GENEXA KIDS PAIN AND FEVER", "FOSTER AND THRIVE CHILDRENS PAIN AND FEVER", "ACETAMINOPHEN 325 MG", "CHILDREN ACETAMINOPHEN", "365 WHOLE FOODS MARKET ACETAMINOPHEN", "CAREONE 8 HOUR PAIN RELIEF", "PAIN AND FEVER CHEWABLES CHILDRENS", "NOTTS - MUSCLE ACHES AND PAIN", "CIRCLE K PAIN RELIEVER EXTRA STRENGTH", "EXTRA STRENGTH PAIN RELEIF", "ACETAMINOPHEN SOLUTION", "NEO-LUBRINA CHILDREN", "LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER", "PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH", "EQUATE PAIN AND FEVER CHILDRENS", "PAIN RELIEVER FEVER REDUCER CHILDRENS", "ACETAMINOPHEN (RED)", "CHILDRENS PAIN AND FEVER, GRAPE FLAVOR", "DESENFRIOL-ITO PLUS", "TYLENOL 8HR", "CHILDRENS ACETAMINOPHEN ORAL SUSPENSION", "DURALGINA", "MAJOR ACETAMINOPHEN", "MOMMYS BLISS CHILDRENS PAIN AND FEVER", "DG HEALTH PAIN RELIEF", "CHILDRENS FEVER REDUCER AND PAIN RELIEVER", "LIQUID ACETAMINOPHEN", "GENEXA INFANTS PAIN AND FEVER", "TYLENOL EXTRA STRENGTH, TRAVEL BASIX", "TYLENOL EXTRA STRENGTH, CVP HEALTH", "PHARBETOL", "8HR ARTHRITIS PAIN RELIEF", "SIGNATURE CARE PAIN RELIEF", "PARRY-500MG ACETAMINOPHEN", "ACETAMINOPHEN 650MG", "PAIN RELIEF EXTRA STRENGTH, NON-ASPIRIN", "CHILDRENS PAIN AND FEVER CHERRY FLAVOR", "GOOD SENSE PAIN AND FEVER INFANTS", "RUGBY INFANTS ACETAMINOPHEN", "PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH", "8HR PAIN RELIEF", "DOLO - NEUROBION ACETAMINOPHEN MAX EXTENDED-RELEASE 650 MG", "PARENTS CHOICE INFANTS PAIN AND FEVER", "VICKS PAINQUIL PAIN RELIEVER", "FEVERALL JR. STRENGTH", "DR KIDS PAIN AND FEVER", "DG HEALTH 8 HOUR PAIN RELIEF", "AUROPHEN EXTRA STRENGTH FOR ADULTS", "CAREALL NON ASPIRIN EXTRA STRENGTH", "EXTRA STRENGTH MINI SOFTGELS PAIN RELIEVER", "MEDI-FIRST EXTRA STRENGTH NON ASPIRIN", "MEDI-FIRST PLUS EXTRA STRENGTH NON ASPIRIN", "MEMBERS MARK ACETAMINOPHEN", "ONESSIP ACETAMINOPHEN", "GOOD SENSE PAIN AND FEVER", "SAFETYNADOL", "CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER", "MAX RELIEF JUNIOR", "EQUATE PAIN RELIEF", "LEADER ACETAMINOPHEN", "RAPIDOL", "FEVERALL INFANTS", "ATAMEL FORTE", "KOSHER MEDS CHILDRENS PAIN AND FEVER", "EXTRA STRENGTH NO-PAIN", "MUSCLE ACHES AND PAINS ACETAMINOPHEN EXTENDED RELEASE", "GREEN GUARD MAXIMUM STRENGTH NON-ASPIRIN", "TEMPERAL-ITO", "EXCEDRIN RAPID RELIEF", "PUREGEN LABS ACETAMINOPHEN", "HENRY SCHEIN ACETAMINOPHEN", "8 HR PAIN RELIEF", "ED APAP", "INFANTS PAIN AND FEVER CHERRY FLAVOR", "PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH", "WELBY ACETAMINOPHEN", "MEDIQUE AT HOME APAP", "PAIN RELIEF 8 HR", "THOMPSON EXTRA STRENGTH NON-ASPIRIN", "CROCIN MAX", "ADWE CHILDRENS PAIN FEVER", "TOPCARE PAIN AND FEVER", "GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEF", "CHILDRENS CHEWABLES", "MCKESSON ACETAMINOPHEN 325", "CHILDRENS PAIN PLUS FEVER RELIEF", "RUGBY CHILDRENS ACETAMINOPHEN", "EQUATE INFANTS PAIN AND FEVER", "EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY", "FAST ACTING PEDIA CRAE", "DOLEX CHILDREN PAIN AND FEVER", "DIRECT SAFETY ASPIRIN FREE", "SIGNATURE CARE INFANTS PAIN RELIEF", "RUGBY REGULAR STRENGTH ACETAMINOPHEN", "WALGREEN CHILDRENS PAIN PLUS FEVER", "CHILDRENS ACETAMINOPHEN DYE FREE GRAPE", "CHILDRENS PAIN RELIEF AND FEVER REDUCER ORAL SUSPENSION CHERRY", "UNISHIELD EXTRA STRENGTH NON-ASPIRIN", "UNISHIELD EXTRA STRENGTH NON ASPIRIN", "GENEXA CHILDRENS ACETAMINOPHEN", "RIGHT REMEDIES PAIN RELIEF EXTRA STRENGTH CAPLET", "DG HEALTH 8 HR ARTHRITIS PAIN RELIEF", "VITAPIRENA", "PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH", "GOODNOW PAIN RELIEF", "GOOD SENSE INFANTS PAIN AND FEVER", "GOOD NEIGHBOR PHARMACY PAIN AND FEVER CHILDRENS", "EQUATE MENSTRUAL PAIN RELIEF", "LEADER 8HR ARTHRITIS PAIN RELIEF", "MAPAP EXTRA STRENGTH", "MANTRA PAIN GEL RASPBERRY", "RINGL", "BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER", "DYE FREE PAIN AND FEVER CHILDRENS", "RAPID RELEASE PAIN RELIEF", "NON-ASPIRIN CHILDRENS", "APHEN", "CHILDREN PAIN AND FEVER RELIEVER", "CHILDRENS PAIN RELIEVER AND FEVER REDUCER CHERRY", "DR. COCOA FOR CHILDREN PAIN AND FEVER", "KINDERFARMS CHILDRENS PAIN AND FEVER", "GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN", "CETAFEN", "ARTHRITIS PAIN ACETAMINOPHEN", "BERKLEY AND JENSEN PAIN RELIEF", "PHARBETOL REGULAR STRENGTH", "BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN", "XPECT ACETAMINOPHEN", "TYLENOL EXTRA STRENGTH CAPLET", "DYE FREEINFANTS PAIN AND FEVER", "EQUATE CHILDRENS PAIN AND FEVER", "CAREONE ACETAMINOPHEN", "ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH", "CHILDRENS MAPAP", "DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE", "8 HR ARTHRITIS PAIN RELIEF", "PAIN RELIEVER DYE FREE", "RESFRIOL-ITO CHILDREN", "FOSTER AND THRIVE RAPID RELEASE PAIN RELIEF", "ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG", "BERKLEY AND JENSEN ACETAMINOPHEN", "CHILDRENS PAIN AND FEVER DYE FREE", "8 HR MUSCLE ACHES AND PAIN", "8HR MUSCLE ACHES AND PAIN RELIEF", "NITE-TIME COLD/FLU MEDICINE", "DR SIMI PAIN RELIEF", "GESTEIRA", "CARE ONE ARTHRITIS PAIN RELIEF", "LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER" ], "generic_name": [ "ACETAMINOPHEN", "ACETAMINOPHEN 500MG", "ACETAMINOPHEN TABLET EXTENDED RELEASE", "PAIN RELIEVER" ], "manufacturer_name": [ "Amazon.com Services LLC", "Meijer, Inc.", "JHK Inc dba American Safety & First Aid", "H E B", "Sixarp, LLC", "PAI Holdings, LLC dba PAI Pharma", "HYVEE INC", "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "L.N.K. International, Inc.", "AMERISOURCE BERGEN", "WALMART INC. (see also Equate)", "Walgreen Company", "Kroger Company", "AptaPharma Inc.", "Topco Associates LLC", "Granules USA, Inc", "Advance Pharmaceutical Inc.", "Meijer Distribution Inc", "Strategic Sourcing Services LLC", "FAMILY DOLLAR SERVICES INC", "Kenvue Brands LLC", "Genexa Inc.", "WALGREENS", "LIDL US LLC", "Medline Industries, LP", "PUBLIX SUPERMARKETS, INC", "KROGER COMPANY", "Farmacias De Similares TX LLC", "Pinnacle RX LLC", "VALU MERCHANDISERS COMPANY", "HEB", "Magno-Humphries, Inc.", "Hi-Tech Nutraceuticals, LLC", "CVS PHARMACY", "New World Imports, Inc", "Chain Drug Marketing Association", "Cardinal Health 110, LLC. dba Leader", "Aurohealth LLC", "DISCOUNT DRUG MART", "United Natural Foods, Inc. dba UNFI", "American Health Packaging", "P & L Development, LLC", "GERI-CARE PHARMACEUTICAL CORP", "Major Pharmaceuticals", "TIME CAP LABORATORIES, INC", "Rite Aid Corporation", "Meijer", "Padagis Israel Pharmaceuticals Ltd", "LEADER/ Cardinal Health 110, Inc.", "Target Corporation", "Acetris Pharma Holdings, LLC", "Better Living Brands, LLC", "Valu Merchandisers Company", "Dolgencorp Inc", "Pharmadel LLC", "Softgel Healthcare Pvt Ltd", "Chain Drug Marketing Association, Inc.", "Dolgencorp, LLC", "Wal-Mart Stores Inc", "KinderFarms, LLC", "HyVee Inc", "HARRIS TEETER", "Amerisource Bergen", "MAJOR PHARMACEUTICALS", "GoodSense", "TOPCO ASSOCIATES LLC", "BLESSINGS INTERNATIONAL", "OPMX Chula Vista", "WinCo Foods, LLC", "COSTCO WHOLESALE CORPORATION", "Grocery Outlet, Inc.", "CVS Pharmacy", "BJWC (Berkley & Jensen / BJ's)", "Wildman Business Group", "WALMART INC.", "Dr. Reddy's Laboratories Inc.", "Bi-Mart", "Walgreens", "Allegiant Health", "TIME CAP LABORATORIES, INC.", "Athlete's Needs, Inc.", "Safeway", "ARMY AND AIR FORCE EXCHANGE SERVICE", "PUBLIX SUPER MARKETS INC", "MEIJER, INC.", "Cabinet Health P.B.C.", "Family Dollar, Inc.", "STRATEGIC SOURCING SERVICES LLC", "WAL-MART STORES INC", "Haleon US Holdings LLC", "WALGREEN CO.", "CVS HEALTH CORP", "CVS PHARMACY INC", "FSA STORE INC.", "Unifirst First Aid Corporation", "AAA Pharmaceutical, Inc.", "INGLES MARKETS, INC.", "L. Perrigo Company", "NUVICARE LLC", "Rnv LLC", "Shield Pharmaceuticals Corp", "CVS Pharmacy, Inc.", "Geri-Care Pharmaceutical Corp", "Strategic Sourcing Services, LLC", "Granules USA, Inc.", "Richmond Pharmaceuticals, Inc.", "Granules Pharmaceuticals Inc.", "MARC GLASSMAN, INC.", "Walmart Inc", "Method Pharmaceuticals, LLC", "Publix Super Markets Inc", "CVS PHARMACY, INC.", "Marlex Pharmaceuticals Inc", "Harris Teeter", "Menper Distributors, Inc.", "Safeway, Inc.", "Uline", "Ellywell, LLC", "DLC Laboratories, Inc.", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "BENARD INDUSTRIES INC", "Camber Pharmaceuticals, Inc.", "WALMART INC", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Sam's West Inc", "OPMX LLC", "Lil' Drug Store Products, Inc.", "CARDINAL HEALTH", "DOLGENCORP, LLC", "SAFEWAY", "Rising Pharma Holdings, Inc.", "DeMoulas Market Basket", "Salado Sales, Inc.", "Llorens Pharmaceutical International Division, Inc.", "Topco Associates, LLC", "The Procter & Gamble Manufacturing Company", "CVS PHARMACY, INC", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services, Inc.", "MEIJER DISTRIBUTION INC", "TIME CAP LABS INC", "WALGREENS CO.", "Mom Enterprises, LLC.", "Mylan Institutional LLC", "Reliable 1 Laboratories LLC", "Belmora LLC", "Bayer HealthCare LLC.", "Sagent Pharmaceuticals", "Costco Wholesale Company", "Caplin Steriles Limited", "WALGREEN COMPANY", "Family Dollar (FAMILY WELLNESS)", "Civica, Inc.", "AMERICAN SALES COMPANY", "TARGET CORPORATION", "Demoulas Super Markets, Inc", "Oncor Pharmaceuticals", "Melaleuca, Inc.", "Sun Pharmaceutical Industries, Inc.", "Raritan Pharmaceuticals Inc.", "FOODHOLD U.S.A., LLC", "VIVUNT PHARMA LLC", "Baxter Healthcare Corporation", "SAM'S WEST INC", "Sandoz Inc", "Cardinal Health 110, LLC. DBA Leader", "Breeden Brothers, LLC", "B. Braun Medical Inc.", "Family Dollar Services Inc", "MEIJER", "QUALITY CHOICE (Chain Drug Marketing Association)", "Chain Drug Consortium", "AARNA USA INC.", "HART Health", "GADAL Laboratories, Inc", "CVS PHARMACY iNC", "CHAIN DRUG MARKETING ASSOCIATION INC", "Rugby Laboratories", "Retail Business Services, LLC", "Discount Drug Mart", "Kroger", "AMERIFOODS TRADING COMPANY", "WG Critical Care, LLC", "American Sales Company", "Genexa, Inc.", "Pioneer Life Sciences, LLC", "Whole Foods Market, INC.", "Shield Pharmaceuticals Corp.", "Solupharm Pharmazeutische Erzeugnisse GmbH", "Walmart", "Marc Glassman, Inc.", "Orelli Inc.", "Patrin Pharma, Inc.", "CHAIN DRUG CONSORTIUM", "BETTER LIVING BRANDS LLC.", "Medtech Products Inc.", "Acme United Corporation", "PuraCap Pharmaceutical LLC", "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Menper Distributors Inc.", "RITE AID", "Granules India Limited", "RETAIL BUSINESS SERVICES , LLC.", "Walmart Inc.", "Prostat First Aid", "Hikma Pharmaceuticals USA Inc.", "LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION", "BluePoint Laboratories", "LEADER/ Cardinal Health 110, Inc", "Family Dollar Stores, LLC", "Pharbest Pharmaceuticals, Inc.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Velocity Pharma LLC", "Better Living Brands LLC", "MDC PHARMACEUTICALS LIMITED", "Forreal Pharmaceuticals, LLC", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "CalmCo LLC", "Best Choice (Valu Merchandisers Company)", "Meijer Distribution, Inc.", "TopCo Associates LLC", "BETTER LIVING BRANDS, LLC", "MEDWISE LIFESCIENCES INC.", "Westminster Pharmaceuticals, LLC", "Sinew Pharma Inc.", "FSA Store Inc.", "Genomma Lab USA, Inc.", "Akron Pharma Inc.", "Mollec Inc", "Safrel Pharmaceuticals, LLC.", "Advanced Rx LLC", "Henry Schein, Inc.", "Health Pharma USA LLC", "DOLGENCORP, INC.", "EDWARDS PHARMACEUTICALS, INC.", "FAMILY DOLLAR", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Aldi, Inc", "Fresenius Kabi USA, LLC", "Thompson", "CVS Pharmacy,Inc.", "RARITAN PHARMACEUTICALS INC", "McKesson Medical-Surgical, Inc.", "CVS Pharmacy, Inc", "Randob Labs., Ltd.", "Conney Safety Products, LLC", "RUGBY LABORATORIES", "FSA Store Inc. (Caring Mills)", "Puro Pharma Inc.", "THE KROGER CO", "Unishield", "Strive Pharmaceuticals Inc.", "RAONBIO CORP", "Trifecta Pharmaceuticals USA LLC", "Gobrands, Inc", "CVS", "MOREMED INC.", "RETAIL BUSINESS SERVICES,LLC.", "Sato Pharmaceutical Co., Ltd.", "BETTER LIVING BRANDS LLC", "WINCO FOODS, LLC", "Asclemed USA, Inc.", "Infirst Healthcare Inc.", "McKesson", "BJWC", "AmeriSource Bergen", "Cintas Corporation", "Jones Healthcare Group - Packaging Services, Inc", "Aurex Laboratories Limited Liability Company", "HHH Pharmaceuticals", "Advagen Pharma Limited", "MARKSANS PHARMA LIMITED", "UNFI", "Gland Pharma Limited", "Eugia US LLC" ], "product_ndc": [ "72288-405", "79481-0302", "73598-1122", "73598-1124", "59640-766", "59368-210", "0121-2094", "42507-404", "52412-906", "50844-519", "46122-629", "79903-172", "0363-1502", "30142-561", "76281-526", "36800-202", "69848-008", "36800-455", "17714-013", "41250-148", "70677-1138", "55319-206", "50580-579", "69676-0059", "0363-9781", 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"ANDA207956", "ANDA208122", "ANDA209476", "NDA018314", "505G(a)(3)", "part349", "NDA202832", "NDA021569", "M012", "NDA018800", "ANDA212248", "ANDA078177", "NDA017464", "ANDA088912", "NDA016733", "NDA018016", "NDA016677", "ANDA206171", "NDA018803", "NDA017867", "NDA018090", "NDA016366", "NDA017427", "ANDA212070", "ANDA217796", "NDA019465", "ANDA211968", "NDA019022", "ANDA088911" ], "brand_name": [ "SODIUM CHLORIDE", "CVS HEALTH STERILE SALINE MIST", "HYPERTONIC SALINE", "LICEFREEE EVERYDAY", "SALINE CLEANING", "OHTRUST ARTIFICAL EYEDROP", "AQUA MARINA", "NATRUM MURIATICUM", "STERILE SALINE MIST WALGREENS", "SALINE NASAL", "WALGREENS", "MURO 128", "CVS HEALTH STERILE SALINE MIST LIVE BETTER", "0.9SALINE", "WHWSWB 0.9% SALINE", "HYPERTONIC SALINE SOLUTION SODIUM CHLORIDE", "RESP EASE", "STERILE SALINE MIST RITE AID", "DG HEALTH STERILE SALINE MIST", "WALGREENS SODIUM CHLORIDE OPHTHALMIC 5 PERCENT HYPERTONICITY EYE", "SODIUM CHLORIDE HYPERTONICITY", "SINUCLEANSE NASAL DRIP", "D-129", "WORAFY GENTLE EYE WASH", "0.9% SODIUM CHLORIDE SALINE SOLUTION", "LICEFREEE", "SODIUM CHLORIDE NORMAL SALT", "ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT", "STERILE SALINE KIDS MIST PEDIAMEDS", "QUALITY CHOICE SALINE", "STERILE SALINE MIST MEIJER", "SINUCLEANSE STERILE SALINE MIST DAILY CARE", "WINCO FOODS SALINE NASAL RELIEF", "0.9 PERCENTSALINE", "SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION", "BASE LABORATORIES SALINE", "RHINOMEL MANUKA", "WALGREENS SALINE MIST EXTRA STRENGTH", "NATRUM MURIATICUM 6X", "FAMILY CARE SALINE", "BACTERIOSTATIC SODIUM CHLORIDE", "ANCIENT SECRETS BREATHE AGAIN", "STERILE HYPERTONIC SALINE SOLUTION 7 SODIUM CHLORIDE", "EXTRA STRENGHT SALINE MIST RITE AID", "NORMAL SALT", "HYDRA NEB", "NAT MUR", "SINUCLEANSE STERILE SALINE MIST", "SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC", "ALTACHLORE SODIUM CHLORIDE HYPERTONICITY", "STERILE SALINE KIDS MIST SINUCLEANSE BREATHE", "NAT MUR 6X", "BURBLE", "0.9%SALINE", "SODIUM CHLORIDE 1 GRAM", "SODIUM 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FORMING", "CAREONE NIGHTTIME SLEEP AID", "DIPHENHYDRAMINE HCL ORAL SOLUTION", "BENADRYL ALLERGY", "CVS HEALTH NIGHTTIME SLEEP-AID", "CAREONE ALLERGY RELIEF", "TOPCARE SLEEP AID NIGHTTIME", "SLEEP AID", "SIMPLY SLEEP", "TOPCARE ALLERGY RELIEF", "ALLERGY ANTIHISTAMINE", "MEIJER NIGHTTIME SLEEP-AID BERRY FLAVOR", "DIMETAPP COUGH AND ALLERGY", "AXIV ALLERGY RELIEF", "CHILDRENS CHEWABLE ALLERGY RELIEF", "ADULT ALLERGY RELIEF DYE FREE", "ALLERGY CHILDRENS ALLERGY", "DYE FREE CHILDRENS ALLERGY RELIEF", "GOOD REMEDIES ALLERGY RELIEF", "GOOD NEIGHBOR PHARMACY ALLERGY", "UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID", "MEIJER ALLERGY RELIEF", "PREMIER VALUE NIGHTTIME SLEEP-AID LIQUID SLEEP-AID", "CHILDRENS ALLERGY RELIEF", "DG HEALTH SLEEP AID", "WELBY ALLERGY RELIEF", "CAREALL ALLERGY RELIEF", "GOOD SENSE NIGHTTIME SLEEP AID", "DIPHENHYDRAMINE ORAL LIQUID", "DIMETAPP NIGHTTIME COLD AND COUGH", "GOOD REMEDIES NIGHTTIME SLEEP AID CAPLETS", "ALLERGY", "SOMNAPURE CLINICAL STRENGTH", "AXIV - VROZZZ", "VICKS ZZZQUIL NIGHTTIME SLEEP-AID", "NIGHTTIME SLEEP AID BERRY FLAVOR", "ITCH RELIEF", "BASIC CARE ALLERGY RELIEF", "DG HEALTH ALLERGY RELIEF", "CAREALL DIPHENHYDRAMINE", "CVS HEALTH NIGHTTIME SLEEP AID", "ZZZQUIL", "SLEEP-AID DIPHENHYDRAMINE HCL", "NIGHTTIME SLEEP-AID SOFTGEL", "CIRCLE K ALLERGY ANTIHISTAMINE", "EQUATE ALLERGY RELIEF", "CVS DYE-FREE CHILDRENS ALLERGY", "WAL DRYL CHILDRENS ALLERGY", "VICKS ZZZQUIL FREE AND CLEAR NIGHTTIME SLEEP-AID", "LEADER NIGHTTIME SLEEP-AID", "CHILDRENS ALLERGY RELIEF DYE FREE BUBBLE GUM", "NYT TIME SLEEP CAPS", "VICKS ZZZQUIL NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCL FREE OF", "VALUMEDS ALLERGY RELIEF ANTIHISTAMINE DIPHENHYDRAMINE HCL", "BENADRYL ALLERGY LIQUI-GELS", "BENADRYL ALLERGY EXTRA STRENGTH LIQUI-GELS", "BENADRYL EXTRA STRENGTH ITCH STOPPING", "BETR SLEEP AID", "DYE FREE WAL SLEEP Z", "NIGHTTIME SLEEPAID", "SLEEP AID NIGHTTIME", "QUALITY CHOICE NIGHTTIME SLEEP-AID", "DIPHENHYDRAMINE", "HARRIS TEETER ALLERGY RELIEF", "ZZZQUIL NIGHTTIME SLEEP-AID", "GOOD NEIGHBOR ALLERGY RELIEF", "EQUATE NIGHTTIME SLEEP-AID", "QUALITY CHOICE ALLERGY RELIEF", "WALGREEN ITCH RELIEF GEL", "TARGET DYE FREE CHILDRENS ALLERGY RELIEF", "SLEEPAID SOFTGELS", "FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF", "DORMMY-LON", "KROGER ALLERGY RELIEF", "GOOD SENSE ALLERGY RELIEF", "NIGHTTIME SLEEP AID MAXIMUM STRENGTH", "VICKS NYQUIL KIDS FREE OF ARTIFICIAL DYES AND SUGAR COLD AND COUGH PLUS RUNNY NOSE", "GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY", "NIGHTTIME SLEEP-AID", "EQUATE NIGHTTIME SLEEP AID", "CHILDRENS BENADRYL CHEWABLES", "GOODMEDS ALLERGY RELIEF DIPHENHYDRAMINE HCL", "MEIJER NIGHTTIME SLEEP AID CAPLET", "NIGHTIME SLEEP AID", "GOOD REMEDIES ALLERGY RELIEF SOFTGEL", "CVS DIPHENHYDRAMINE HYDROCHLORIDE", "DG HEALTH ALLERGY CHILDRENS", "WINCO FOODS CHILDRENS ALLERGY RELIEF DYE FREE", "ALLERGY RELIEF DIPHENHYDRAMINE HCL 25MG SOFTGEL", "DYE FREE ALLERGY CHILDRENS", "RIGHT REMEDIES ALLERGY RELIEF", "BERKLEY AND JENSEN ALLERGY RELIEF", "ADWE DYE-FREE CHILDRENS 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"Avenacy, LLC", "FSA STORE INC.", "Time-Cap Labs, Inc", "DOLGENCORP, LLC", "Medtech Products Inc.", "DXM Pharmacuetical, Inc.", "Gland Pharma Limited", "Discount Drug Mart, Inc", "Bell Pharmaceuticals, Inc.", "Method Pharmaceuticals, LLC", "AptaPharma Inc.", "NUVICARE LLC", "Cintas Corporation", "Tec Laboratories Inc.", "Redmont Pharmaceuticals, LLC", "SAM'S WEST INC", "Strategic Sourcing Services, LLC", "Publix Super Markets Inc", "DLC Laboratories, Inc.", "The Kroger Co.", "HARRIS TEETER", "RITE AID CORPORATION", "TWIN MED LLC" ], "product_ndc": [ "11673-186", "42806-649", "83324-336", "41250-379", "53943-505", "53943-191", "66715-6406", "66715-9706", "66715-6506", "63868-492", "82706-019", "76162-438", "82725-4201", "60687-829", "82673-109", "49483-061", "63868-087", "47682-167", "47682-184", "0363-0100", "68210-4160", "59779-793", "51316-835", "41250-853", "41520-431", "36800-909", "69339-151", "69339-152", "70692-785", "53345-005", "50580-573", "35916-0470", "42507-290", 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"activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "openfda": { "application_number": [ "NDA213051" ], "brand_name": [ "RYBELSUS" ], "generic_name": [ "ORAL SEMAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk Pharmaceutical Industries, LP" ], "product_ndc": [ "0169-4303", "0169-1715", "0169-1704", "0169-1709", "0169-4307", "0169-4314", "0169-4815", "0169-4804", "0169-4809" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SEMAGLUTIDE" ], "rxcui": [ "2200644", "2200650", "2200652", "2200654", "2200656", "2200658", "2707547", "2707549", "2707551", "2707553", "2707555", "2707557", "2736944", "2736946", "2736948" ], "spl_id": [ "5176eed4-f8f8-4f88-a079-11f16864f40a" ], "spl_set_id": [ "27f15fac-7d98-4114-a2ec-92494a91da98" ], "package_ndc": [ "0169-1715-30", "0169-1715-90", "0169-1704-30", "0169-1709-30", "0169-4303-01", "0169-4303-13", "0169-4303-90", "0169-4303-93", "0169-4303-30", "0169-4303-99", "0169-4307-01", "0169-4307-13", "0169-4307-30", "0169-4314-01", "0169-4314-13", "0169-4314-30", "0169-4815-30", "0169-4815-90", "0169-4804-30", "0169-4809-30" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "53AXN4NNHX" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20241226" } } } ] }