{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-01-27", "results": { "skip": 0, "limit": 1, "total": 85635 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10255011", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20210716", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140624", "receiptdateformat": "102", "receiptdate": "20210415", "fulfillexpeditecriteria": "1", "companynumb": "US-BAXTER-2014BAX031884", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-BAXTER-2014BAX031884" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "78", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "24.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.0", "reactionmeddrapt": "Headache", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.0", "reactionmeddrapt": "Muscle spasms", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.0", "reactionmeddrapt": "Infusion related reaction", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.0", "reactionmeddrapt": "Back pain", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HUMAN NORMAL IMMUNOGLOBULIN; LIQUID", "drugauthorizationnumb": "125105", "drugdosagetext": "UNK", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "IMMUNODEFICIENCY COMMON VARIABLE", "drugstartdateformat": "610", "drugstartdate": "201405", "actiondrug": "4", "activesubstance": { 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RELIEF", "MIDOL LONG LASTING RELIEF", "PAIN RELIEVER CHILDRENS", "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", "CAREALL NON ASPIRIN EXTRA STRENGTH", "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", "NOTTS - MUSCLE ACHES AND PAIN", "CIRCLE K PAIN RELIEVER EXTRA STRENGTH", "EXTRA STRENGTH PAIN RELEIF", "ACETAMINOPHEN SOLUTION", "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", "TYLENOL 8HR", "CHILDRENS ACETAMINOPHEN ORAL SUSPENSION", "DURALGINA", "MAJOR ACETAMINOPHEN", "MOMMYS BLISS CHILDRENS PAIN AND FEVER", "DG HEALTH PAIN RELIEF", "ARTHRITISPAIN RELIEF", "PREMIER VALUE ARTHRITIS PAIN RELIEVER", "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", "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", "DG HEALTH 8 HOUR PAIN RELIEF", "AUROPHEN EXTRA STRENGTH FOR ADULTS", "MEDI-FIRST EXTRA STRENGTH NON ASPIRIN", "MEDI-FIRST PLUS EXTRA STRENGTH NON ASPIRIN", "MEMBERS MARK ACETAMINOPHEN", "ONESSIP ACETAMINOPHEN", "GOOD SENSE PAIN AND FEVER", "ACETAMINOPHEN - APAP ARTHRITIS", "SAFETYNADOL", "CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER", "MAX RELIEF JUNIOR", "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", "DR KIDS PAIN AND FEVER", "CROCIN MAX", "ADWE CHILDRENS PAIN FEVER", "TOPCARE PAIN AND FEVER", "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", "ARTHRITIS PAIN RELIEVER EXTENDED RELEASE", "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", "EXTRA STRENGTH MINI SOFTGELS PAIN RELIEVER", "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 NEIGHBOR PHARMACY PAIN AND FEVER CHILDRENS", "LEADER 8HR ARTHRITIS PAIN RELIEF", "MAPAP EXTRA STRENGTH", "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", "DR. COCOA FOR CHILDREN 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", "8 HR ARTHRITIS PAIN", "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", "Meijer", "Farmacias De Similares TX LLC", "VALU MERCHANDISERS COMPANY", "HEB", "Magno-Humphries, Inc.", "CVS PHARMACY", "New World Imports, Inc", "Chain Drug Marketing Association", "Cardinal Health 110, LLC. dba Leader", "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", "Padagis Israel Pharmaceuticals Ltd", "Premier Value", "LEADER/ Cardinal Health 110, Inc.", "Target Corporation", "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.", "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.", "STRATEGIC SOURCING SERVICES LLC", "WAL-MART STORES INC", "Haleon US Holdings LLC", "WALGREEN CO.", "Aurohealth LLC", "CVS HEALTH CORP", "CVS PHARMACY INC", "Chain Drug Marketing Association Inc.", "Sanvall Enterprises, Inc.", "FSA STORE INC.", "Unifirst First Aid Corporation", "AAA Pharmaceutical, Inc.", "INGLES MARKETS, INC.", "L. Perrigo Company", "Rnv LLC", "NUVICARE 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", "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", "Lil' Drug Store Products, Inc.", "CARDINAL HEALTH", "DOLGENCORP, LLC", "SAFEWAY", "Rising Pharma Holdings, Inc.", "Salado Sales, Inc.", "Llorens Pharmaceutical International Division, Inc.", "Topco Associates, LLC", "The Procter & Gamble Manufacturing Company", "Easyfast Supplements LLC", "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", "OPMX 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.", "Solupharm Pharmazeutische Erzeugnisse GmbH", "Walmart", "Marc Glassman, 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", "Chain Drug Consortium, LLC.", "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", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "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", "Fred's Inc.", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Aldi, Inc", "Fresenius Kabi USA, LLC", "Thompson", "CalmCo LLC", "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", "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 PHARMA USA LLC", "Advagen Pharma Limited", "MARKSANS PHARMA LIMITED", "UNFI", "Menper Distributors, Inc.", "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", 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"XICLO", "DICLOFENAC" ], "generic_name": [ "DICLOFENAC", "DICLOFENAC SODIUM" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Encube Ethicals, Inc.", "Strand Health Group", "Amneal Pharmaceuticals NY LLC", "Scholl's Wellness Company", "Altaire Pharmaceuticals Inc." ], "product_ndc": [ "65162-683", "21922-033", "65162-911", "83295-5500", "69238-2053", "73469-2053", "59390-149" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "TOPICAL", "TRANSDERMAL", "OPHTHALMIC" ], "substance_name": [ "DICLOFENAC SODIUM", "DICLOFENAC" ], "rxcui": [ "1487074", "857700", "2705052", "2705057", "855633", "854801" ], "spl_id": [ "1affc043-5b84-4b94-97be-90f3bd954f34", "28dafbef-5a91-4435-b48d-00137ea268b5", "6feda2fe-70b6-4dbe-a969-97857501dd1f", "463f4bb7-e16f-4966-e063-6294a90a58eb", "a723bc13-8e04-48e5-8427-5cb5e6471e4a", "3f399f7d-a801-4fce-9c3a-7e3a4d6e2507", "0561ff06-43b4-493e-93f7-b778fc829036" ], "spl_set_id": [ "45321aec-368d-4ca4-a0c5-2ce56fae74b2", "e7304b3e-530a-4519-aed0-bed4512d8925", "78873f83-cea9-44d4-8ad4-8cb9257e5c7f", "2d93a01c-40a9-8fb0-e063-6394a90a2cc6", "1084e0c3-6d75-4090-84dc-02a18e0299b9", "8dcbce69-945b-4913-a279-ee10871f6580", "5372866a-dab3-45c8-8c2a-755ca36c1791" ], "package_ndc": [ "65162-683-12", "21922-033-16", "65162-911-74", "83295-5500-1", "69238-2053-1", "73469-2053-1", "73469-2053-8", "59390-149-02", "59390-149-05" ], "unii": [ "QTG126297Q", "144O8QL0L1" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BASAGLAR", "drugdosagetext": "UNK", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA205692" ], "brand_name": [ "BASAGLAR KWIKPEN", "BASAGLAR TEMPO PEN" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-7715", "0002-8214" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "847230", "1736863", "2268064", "2268065" ], "spl_id": [ "3c2283e6-2844-44d2-a447-579b07e77c27" ], "spl_set_id": [ "0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae" ], "package_ndc": [ "0002-7715-01", "0002-7715-59", "0002-7715-63", "0002-8214-01", "0002-8214-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2014" } } } ] }