{ "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. 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Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MULTIVITAMIN /00097801/", "drugdosageform": "TABLET" }, { "drugcharacterization": "2", "medicinalproduct": "NIACIN", "drugdosageform": "TABLET", "openfda": { "application_number": [ "ANDA204178", "ANDA090892", "ANDA040378", "ANDA203899", "ANDA203578", "ANDA209236", "ANDA200484", "ANDA201273", "ANDA204934" ], "brand_name": [ "NIACIN", "NIACOR" ], "generic_name": [ "NIACIN" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Lupin Pharmaceuticals, Inc.", "Avondale Pharmaceuticals, LLC", "Chartwell RX, LLC", "Lannett Company, Inc.", "Aurobindo Pharma Limited", "Redmont Pharmaceuticals, LLC", "Emerald Therapeutics, LLC", "Sun Pharmaceutical Industries, Inc.", "Macleods Pharmaceuticals Limited" ], "product_ndc": [ "65162-322", "68180-222", "68180-221", "68180-223", "71740-001", "62135-497", "62135-498", "65162-321", "65162-323", "62175-320", "62175-322", "59651-018", "59651-019", "59651-020", "71741-020", "72919-420", "47335-539", "47335-614", "47335-613", "33342-187", "33342-189" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NIACIN" ], "rxcui": [ "1098143", "1098134", "1098141", "198024", "311944" ], "spl_id": [ "b75c66ae-a08b-439c-b526-7897a38bc3a8", "309a40e8-333f-478a-8a94-beff7f3ca5b2", "800ff22d-b10c-4cc8-920f-217a4d23563d", "456edffe-25de-6095-e063-6294a90a7d57", "0b4acd9a-d32e-4727-a9c3-3754a375840c", "7e9530d1-a940-42e8-b754-0d4089b39db1", "8539231f-47da-402e-b05d-16c45cc3670c", "984e26b5-be06-4b88-b13b-7488fcb46516", "f80225f4-fe62-4807-8369-7cf33e0161dd", "bc18daa3-5321-43bd-9d00-dabd9adac571", "2b583ae0-4d24-bd44-e063-6394a90a0ced" ], "spl_set_id": [ "7250313b-b2ef-4736-bd25-2f29c2ac0eb9", "92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9", "bf287412-160b-403f-8eb4-57f29a475902", "568c3a99-b6e8-48b4-bb68-867bbcefa027", "6e604319-e164-4056-ab80-b78b98c519c7", "d7b66e13-00ed-48a9-a54a-8e474cc31d54", 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"47335-613-18", "33342-187-10", "33342-187-11", "33342-189-10", "33342-189-11" ], "nui": [ "N0000175594", "M0014839" ], "pharm_class_epc": [ "Nicotinic Acid [EPC]" ], "pharm_class_cs": [ "Nicotinic Acids [CS]" ], "unii": [ "2679MF687A" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZYRTEC", "drugdosageform": "CHEWABLE TABLET", "openfda": { "application_number": [ "NDA021621" ], "brand_name": [ "ZYRTEC" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-753" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE" ], "rxcui": [ "1014674", "1020022" ], "spl_id": [ "506ace58-15cc-77b4-e063-6394a90a0813" ], "spl_set_id": [ "dc613bd5-70fd-1d9b-e053-2995a90a41cd" ], "package_ndc": [ "50580-753-24" ], "unii": [ "64O047KTOA" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10004640", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140611", "fulfillexpeditecriteria": "2", "companynumb": "US-INCYTE CORPORATION-2014IN000386", "duplicate": "1", "reportduplicate": { "duplicatesource": "INCYTE", "duplicatenumb": "US-INCYTE CORPORATION-2014IN000386" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "76", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypertension", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Increased appetite", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Weight 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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", "71141-176", "53329-196", "41415-177", "36800-779", "41226-699", "50580-490", "85786-102", "41250-959", "87438-0001", "63941-303", "70677-0117", "37808-120", "54257-473", "69732-001", "69842-750", "51824-061", "0121-0941", "0121-1882", "0121-2823", "41250-590", "83324-081", "70000-0674", "58602-171", "0363-9538", "53943-103", "41163-045", "50580-576", "0363-7008", "60687-751", "49580-0821", "57896-148", "0904-7445", "49483-342", "11822-4450", "41250-946", "50580-783", "41250-501", "50580-177", "45802-732", "70000-0036", "70000-0709", "70000-0410", "58602-172", "11673-133", "30142-818", "52343-555", "50580-495", "21130-223", "63941-519", "55910-738", "55758-439", "51316-695", "35916-0183", "83324-071", "50580-170", "55910-251", "49035-175", "82673-098", "11822-0766", "42507-804", "72036-092", "46122-764", "0904-7014", "50804-826", "58602-748", "36800-632", "51376-130", "52412-901", "69729-118", "49580-3278", "67091-135", "50580-937", "72288-698", "69842-445", "0363-6555", "50580-139", 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[ "Benzodiazepines [CS]" ], "unii": [ "YU55MQ3IZY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN", "drugstructuredosagenumb": "81", "drugstructuredosageunit": "003", "drugdosagetext": "81 MG, QD", "drugadministrationroute": "048", "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", 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ANTACID", "EXTRA STRENGTH SMOOTH PEPPERMINT ANTACID", "REGULAR STRENGTH ANTACID REGULAR STRENGTH ANTACID", "EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR", "EXTRA STRENGTH SUGAR FREE ANTACID", "KOSHER MEDS ANTACID", "ANTACID EXTRA STRENGTH", "KIDS ANTACID", "PUBLIX EXTRA STRENGTH ASSORTED BERRY", "KROGER ULTRA STRENGTH ASSORTED FRUIT", "DG HEALTH EXTRA STRENGTH ASSORTED FRUITS ANTACID", "ANTACID EXTRA STRENGTH ASSORTED BERRY", "TUMS ULTRA", "MGC HEALTH CALCIUM CARBONATE ANTACID ASSORTED BERRIES", "XPECT ANTACID", "HYVEE ULTRA STRENGTH ANTACID SOFT CHEWS CHERRY", "ULTRA STRENGTH ANTACID ASSORTED FRUIT", "GUARDIAN EXTRA STRENGTH ANTACID", "CHILDRENS STOMACH RELIEF ANTACID", "CAREONE EXTRA STRENGTH ASSORTED FRUITS", "ULTRA STRENGTH ANTACID TROPICAL FRUIT FLAVOR", "TUMS CHEWY BITES PEPPERMINT", "ALKA-SELTZER COOL ACTION EXTRA STRENGTH RELIEFCHEWS MINT", "WALGREENS EXTRA STRENGTH SMOOTH ANTACID", "RUGBY EXTRA STRENGTH ANTACID", "BASIC CARE ANTACID FRUIT CHEWS", "RITE AID PHARMACY EXTRA 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"MGC HEALTH CALCIUM CARBONATE ANTACID ASSORTED FRUITS", "HEARTBURN AND GAS FRUIT CHEWS", "ALKA-SELTZER EXTRA STRENGTH HEARTBURN RELIEFCHEWS", "CALCIUM ANTACID", "ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE", "MCKESSON ANTACID CALCIUM CARBONATE", "CALCIUM CARBONATE ANTACID ASSORTED BERRIES", "MIXED BERRY ANTACID AND ANTI-GAS CHEWS", "EXCHANGE SELECT ULTRA STRENGTH ANTACID ASSORTED FRUIT", "ALKA-SELTZER COOL ACTION HEARTBURN RELIEF MINT", "RITE AID EXTRA STRENGTH ASSORTED FRUIT", "TUMEEZ ORGANIC APPLE", "TUMEEZ ORGANIC GRAPE", "TUMEEZ VARIETY PACK", "TOPCARE ULTRA STRENGTH ANTACID PEPPERMINT", "ANTACID CHILDRENS", "AMAZON ULTRA STRENGTH ANTACID", "ASSORTED FRUIT ANTACID CHEWS", "RITE AID EXTRA STRENGTH ASSORTED FRUITS", "HEB ANTACID CALCIUM ASSORTED BERRY", "EXTRA STRENGTH NATURAL ANTACID", "UNISHIELD ANTACID", "CHILDRENS TUMMY RELIEF", "GUARDIAN ULTRA STRENGTH ANTACID ASSORTED FRUIT", "BI-MART EXTRA STRENGTH ANTACID ASSORTED BERRY", "PHYSICIANSCARE ANTACID", "CVS NATURALS", "DG HEALTH ULTRA STRENGTH ASSORTED BERRY ANTACID", "PUBLIX ULTRA STRENGTH ASSORTED FRUIT", "GUARDIAN REGULAR STRENGTH ALKUMS", "ANTACID RELIEF", "EXTRA STRENGTH ANTACID SMOOTH DISSOLVE ASSORTED FRUIT", "EXTRA STRENGTH SMOOTH", "DG HEALTH REGULAR STRENGTH ANTACID", "EQU ULTRA STRENGTH ANTACID ASSORTED FRUIT 171AF", "REGULAR STRENGTH ANTACID ASSORTED FRUIT", "RITE AID EXTRA STRENGTH TROPICAL FRUIT", "TOPCARE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "ASSORTED FRUIT ANTACID FLAVOR CHEWS", "TOPCARE CHERRY ANTACID SOFT CHEWS", "FW EXTRA STRENGTH AF SMOOTH ANTACID", "LEADER ULTRA STRENGTH ANTACID", "REGULAR STRENGTH ASSORTED FRUIT", "MGC HEALTH ANTACID SOFT CHEWS CHERRY FLAVOR", "ANTACID FLAVOR CHEW", "NOVA ANTACID", "BI-MART ULTRA STRENGTH ANTACID ASSORTED FRUIT", "ALKUMS ANTACID", "EXTRA STRENGTH SMOOTH ANTACID ASSORTED BERRIES", "CVS PHARMACY ASSORTED FRUIT ANTACID", "MEIJER EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS", "WONDERBELLY MAXIMUM STRENGTH ANTACID - SWEET MINT", "GDC EXTRA STRENGTH ALKUMS ANTACID 127AF", "CHILDRENS ANTACID EXTRA STRENGTH", "BI-MART EXTRA STRENGTH ANTACID ASSORTED FRUIT", "GOODSENSE ULTRA STRENGTH ANTACID PEPPERMINT", "EQUATE WILD BERRY ANTACID CHEWS", "TOPCARE EXTRA STRENGTH ANTACID EXTRA STRENGTH ANTACID ASSORTED BERRY", "GOODSENSE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "TUMS NATURALS", "WINCO FOODS ANTACID EXTRA STRENGTH", "EXTRA STRENGTH ASSORTED FRUIT ANTACID", "PEPTO KIDS", "TUMS CHEWY BITES BERRY SHAKE", "EXTRA STRENGTH ASSORTED BERRY", "BASIC CARE BERRY ANTACID HBG", "EQUATE ULTRA STREGTH ANTACID", "GUARDIAN EXTRA STRENGTH ASSORTED BERRY ANTACID EXTRA STRENGTH ASSORTED BERRY ANTACID", "KIRKLAND ULTRA STREGTH ANTACID 171AB", "CVS ORANGE CREAM ANTACID CHEWS", "EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT", "QUALITY CHOICE ULTRA STRENGTH ASSORTED FRUIT", "QUALITY CHOICE EXTRA STRENGTH ASSORTED FRUIT", "GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT", "ALKA-SELTZER HEARTBURN RELIEFCHEWS", "RITE AID WILD BERRY ANTACID CHEWS", "FAMILY WELLNESS ANTACID RELIEF CHEWS", "TUMS CHEWY BITES ORANGE AND CREAM ES", "WALGREENS CHERRY BERRY LIME ANTACID HBG 54CT", "EXCHANGE SELECT EXTRA STRENGTH ANTACID ASSORTED BERRIES", "TUMS EXTRA STRENGTH SUGAR-FREE", "EQUALINE ULTRA STRENGTH ANTACID ASSORTED BERRY ULTRA STRENGTH ASSORTED FRUIT ANTACID", "EXTRA STRENGTH ASSORTED BERRY ANTACID", "ANTACID FLAVOR CHEWS", "KROGER EXTRA STRENGTH ASSORTED FRUIT", "CITRUS FLAVORED ANTACID", "TARGET ANTACID - ANTI-GAS RELIEF CHEWS", "FAMILY WELLNESS EXTRA STRENGTH ANTACID EXTRA STRENGTH ASSORTED FRUIT ANTACID", "CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH", "HEB ULTRA STRENGTH ASSORTED FRUITS", "EQUQLINE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "TOPCARE CHERRY BERRY LIME ANTACID HBG", "ULTRA STRENGTH ASSORTED FRUIT ANTACID", "AMAZON BASICS CHERRY ANTACID SC", "ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS", "CVS PHARMACY ASSORTED BERRY ANTACID", "ALKA-SELTZER HEARTBURN RELIEF PEPPERMINT", "MARC GLASSMAN EXTRA STRENGTH", "PUBLIX REGULAR STRENGTH PEPPERMINT FLAVOR", "QUALITY CHOICE ASSORTED BERRIES EXTRA STRENGTH", "HEB WILD BERRY ANTACID CHEWS", "TARGET WILD BERRY ANTACID CHEWS 60CT", "MINT ANTACID 100", "MINT ANTACID 250", "CHERRY ANTACID", "MEDIQUE ALCALAK", "MEDI-FIRST ANTACID", "MEDI-FIRST PLUS ANTACID", "QUALITY CHOICE", "FOSTER AND THRIVE EXTRA STRENGTH SUGAR FREE ANTACID ORANGE", "MEIJER ULTRA STRENGTH ANTACID ASSORTED FRUIT", "TOPCARE ULTRA STRENGTH ANTACID ASSORTED BERRY", "BI-MART ULTRA STRENGTH ANTACID PEPPERMINT", "CALCIUM CARBONATE CHEWABLE ANTACID", "GOODSENSE REGULAR STRENGTH ANTACID", "BEST CHOICE REGULAR STRENGTH", "TARGET BERRY LIME HBG CHEWS", "TUMS CHEWY BITES VANILLA AND MINT", "DG HEALTH EXTRA STRENGTH ANTACID", "TOPCARE EXTRA STRENGTH ANTACID ASSORTED FRUIT EXTRA STRENGTH ANTACID ASSORTED FRUIT", "CALCIUM CARBONATE 1250 MG", "MEIJER EXTRA STRENGTH WINTERGREEN FLAVOR", "FAMILY WELLNESS ULTRA STREGTH ANTACID 171AB", "EXTRA STRENGTH ANTACID ORANGE CREAM SUGAR FREE", "R COS", "CALCIUM CARBONATE 10 GR (648 MG)", "HEB EXTRA STREGTH ANTACID", "KROGER EXTRA STRENGTH ASSORTED BERRY", "PUBLIX REGULAR STRENGTH ASSORTED FRUIT", "BEST CHOICE EXTRA STRENGTH ASSORTED BERRY", "GENEXA KIDS TUMMY RELIEF", "EXCHANGE SELECT ANTACID TROPICAL FRUIT", "MEIJER REGULAR STRENGTH ASSORTED FRUIT", "HEB ANTACID EXTRA STRENGTH ASSORTED BERRY", "THOMPSON ANTACID", "TUMS CHEWY DELIGHTS", "MEIJER EXTRA STRENGTH ANTACID", "GOODSENSE REGULAR STRENGTH ANTACID PEPPERMINT", "ULTRA STRENGTH ANTACID PEPPERMINT", "FOSTER AND THRIVE REGULAR STRENGTH ANTACID PEPPERMINT", "HEB REGULAR STRENGTH PEPPERMINT FLAVOR", "CHERRY ANTACID RELIEF CHEW", "GUARDIAN EXTRA STRENGTH SMOOTH ALKUM ANTACID 173BF", "HEB EXTRA STRENGTH TROPICAL FRUIT", "FAMILY WELLNESS ULTRA STRENGTH ASSORTED FRUIT ANTACID ULTRA STRENGTH ASSORTED FRUIT ANTACID", "TOPCARE ANTACID CALCIUM REGULAR STRENGTH", "MARC GLASSMAN ULTRA STRENGTH", "BM CALCIUM CARBONATE (CALC CARB)", "KROGER EXTRA STRENGTH SMOOTH ANTACID ASSORTED BERRY", "ANTACID- CALCIUM CARBONATE", "TUMS EX", "FOSTER AND THRIVE EXTRA STRENGTH ANTACID 127AF EXTRA STRENGTH ANTACID ASSORTED FRUIT", "HEB REGULAR STRENGTH ASSORTED FRUIT", "TUMS REGULAR STRENGTH", "GOOD SENSE ANTACID SOFT CHEW", "BEST CHOICE ASSORTED FRUIT", "QUALITY CHOICE REGULAR STRENGTH PEPPERMINT FLAVOR" ], "generic_name": [ "CALCIUM CARBONATE", "ANTACID" ], "manufacturer_name": [ "WINCO FOODS, LLC", "Retail Business Services, LLC.", "Kroger", "HART Health", "Grocery Outlet, Inc.", "Rite Aid", "KROGER COMPANY", "Seaip co., Ltd", "Family Dollar Services, Inc.", "CVS Pharmacy", "Meijer", "TARGET CORPORATION", "Topco Associates LLC", "Hyvee Inc", "Meijer Distribution Inc", "Unifirst First Aid Corporation", "CHAIN DRUG MARKETING ASSOCIATION", "MEIJER DISTRIBUTION INC", "MEIJER DISTRIBUTION INC.", "Good Sense (Geiss, Destin & Dunn, Inc.)", "Xiamen Kang Zhongyuan Biotechnology Co., Ltd.", "BETTER LIVING BRANDS LLC", "Target", "SAFEWAY", "CARDINAL HEALTH 110, LLC.", "Harris Teeter, LLC", "RARITAN PHARMACEUTICALS INC", "UNITED 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DBA UNFI", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Humco Holding Group, Inc.", "Leosons Overseas Corp.", "Raritan Pharmaceuticals Inc", "Chain Drug Marketing Association Inc.", "Haleon US Holdings LLC", "PNP Pharmaceuticals Inc", "Discount Drug Mart, Inc", "7-ELEVEN", "Genexa Inc.", "Meijer Distribution Inc.", "AmerisourceBergen Drug Corporation", "DeMoulas Market Basket", "WALGREEN CO", "AMERISOURCE BERGEN", "HEB", "AiPing Pharmaceutical, Inc.", "Bi-Mart", "The Procter & Gamble Manufacturing Company", "Reliable 1 Laboratories LLC", "Wal-Mart Stores,Inc.", "DOLGENCORP, LLC", "Topco Associates, LLC", "RITE AID CORPORATION", "Advance Pharmaceutical Inc.", "NPG Bio Pharmaceuticals Co.,Ltd.", "Ginger Health Company", "AKRON PHARMA INC", "PHARMACY VALUE ALLIANCE, LLC", "Allegiant Health", "Target corporation", "Walgreen Co.", "CVS", "BEST CHOICE (VALU MERCHANDISERS COMPANY)", "H E B", "VIVUNT PHARMA LLC", "BETTER LIVING BRANDS, LLC", "Topco Associates LLC.", "CARDINAL HEALTH", "PNP Pharmaceuticals Inc.", "Uline", "CARDINAL HEALTH 110, LLC. DBA LEADER", "American Sales", "Belmora, LLC", "Blessings International", "WHOLE FOODS MARKET, INC.", "Walgreen Company", "GoodSense", "PUBLIX SUPER MARKETS, INC", "Amerisource Bergen", "Mollec Inc", "Richmond Pharmaceuticals, Inc.", "Medical Group Care LLC", "Cintas Corporation", "Wal-Mart Stores,Inc.,", "Guardian Drug Company", "FOODHOLD USA", "ProStat First Aid", "Walmart Stores Inc.", "Army & Air Force Exchange Service", "CVS PHARMACY, INC.", "Bayer HealthCare LLC.", "WALGREENS CO.", "Rugby Laboratories", "Amazon.com", "Strategic Sourcing Services LLC", "Chain Drug Marketing Association, Inc.", "Walgreens", "Bestmade Natural Products", "A&Z Pharmaceutical Inc.", "CVS PHARMACY", "Cardinal Health 107, LLC", "SAM'S WEST INC", "McKesson Medical-Surgical", "Walmart Stores", "ARMY AND AIR FORCE EXCHANGE SERVICE", "BFY LLC", "LIDL US, LLC", "AMAZON.COM SERVICES LLC", "Target Corporation", "PuraCap Pharmaceutical LLC", "Unishield", "THE KROGER CO.", "Acme United Corporation", "Safeway", "Rite Aid Corporation", "Wal-Mart Stores Inc", "Walmart", "TopCo", "Trifecta Pharmaceuticals USA LLC", "MARC GLASSMAN, INC.", "Blueberri Inc.", "CVS HEALTH CORP", "CVS Pharmacy,Inc", "FAMILY DOLLAR SERVICES INC", "Procter & Gamble Manufactura S de RL de CV", "BJWC", "Wal-Mart Stores, Inc.", "PAI Holdings, LLC dba PAI Pharma", "COSTCO WHOLESALE COMPANY", "Family Dollar", "JHK DBA American Safety & First Aid", "Amazon", "WAL-MART STORES INC.", "JHK Inc dba American Safety & First Aid", "Wildman Business Group", "QUALITY CHOICE (Chain drug Marketing Assoiciation)", "Geri-Care Pharmaceutical Corp", "Cardinal Health 110, LLC.", "Walgreens Company", "CitraGen Pharmaceuticals, Inc.", "Hy-Vee Inc", "WALGREEN COMPANY", "Thompson", "H-E-B", "FSA STORE INC.", "MARC GLASSMAN, INC", "BM Private Limited", "Anhui Jiuhe Health Industry Co., Ltd", "Geiss, Destin Dunn" ], "product_ndc": [ "67091-358", "72476-132", "30142-268", "50332-0151", "85828-903", "11822-3510", "30142-300", "82585-303", 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"product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL", "TOPICAL" ], "substance_name": [ "CALCIUM CARBONATE", "DIMETHICONE" ], "rxcui": [ "308892", "308915", "313884", "1358869", "1492387", "308907", "1432465", "308906", "1538595", "1484737", "1044532", "317865", "308901", "1044524", "577040", "2281777", "2204565", "2667489", "204636", "210111", "701392", "308891", "282465", "210117", "1653049" ], "spl_id": [ "44f5a000-3118-a60e-e063-6394a90a0088", "6c4d31c9-192b-4390-92e4-948e8acb1452", "326e3775-d7fa-2fd9-e063-6294a90a059b", "1f253919-2335-4266-a415-c0aacfa2e1dc", "4d5db8d8-b7f8-7946-e063-6394a90a24f9", "3168c90f-a092-ca4d-e063-6394a90a1737", "3c3de8f2-3421-e135-e063-6294a90a7072", "4c1b0b8c-69c3-95a4-e063-6394a90afc61", "ee4aed8d-899e-4a27-9d95-b11151eec298", "456882f3-c8a2-3854-e063-6394a90a8c4b", "464108e4-9e83-2e1b-e063-6294a90a3aeb", "32057a64-7164-6dbc-e063-6394a90a2827", "43118047-20f2-d9c4-e063-6394a90afc25", "0688a639-0392-47a1-ba1f-ea2412dbebba", 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[ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_moa": [ "Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]" ], "unii": [ "U3H27498KS" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NEXIUM", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022101", "NDA021957", "NDA021153" ], "brand_name": [ "NEXIUM" ], "generic_name": [ "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-4010", "0186-5020", "0186-4020", "0186-4040", "0186-5040", "0186-4025", "0186-4050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE" ], "rxcui": [ "606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763" ], "spl_id": [ "26f66e74-b652-4b1d-bfff-62a3cc87d590" ], "spl_set_id": [ "f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RANITIDINE", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "RANITIDINE\\RANITIDINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA078192", "ANDA075294", "ANDA209859", "ANDA077824", "ANDA210243", "ANDA211289", "ANDA077405" ], "brand_name": [ "RANITIDINE", "RANITIDINE COOL MINT" ], "generic_name": [ "RANITIDINE" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Limited", "Ajanta Pharma USA Inc.", "Amneal Pharmaceuticals of New York LLC", "Granules India Ltd", "Rising Pharma Holdings, Inc.", "Pharmaceutical Associates, Inc." ], "product_ndc": [ "55111-404", "55111-131", "27241-109", "27241-110", "53746-253", "53746-254", "62207-773", "62207-774", "64980-636", "64980-637", "0121-0727", "0121-4727" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RANITIDINE HYDROCHLORIDE", "RANITIDINE" ], "rxcui": [ "198191", "312773", "198190", "198192", "198193", "705610" ], "spl_id": [ "c47f1d10-c4d9-5df4-84e8-55956b47568b", "210e3c0b-be93-aa50-550d-e383e7d5f19e", "d7fd99da-f17a-4124-9014-70bbe43d78f6", "906b462d-e4a3-4f23-8d1b-2605476c40e8", "44f2b222-ae43-eef4-e063-6394a90ab2b6", "b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe", "d56a22ea-5dab-e98a-e053-2a95a90a34c4" ], "spl_set_id": [ "00df8a42-296f-80dd-98af-ee8b30eb38cc", "12a38e29-130c-6d41-1753-acccb0b41efe", "fb67e8c7-b817-4253-a1a1-5ecdcee694cf", "b38a3332-5c54-453f-aeb7-070f830955c2", "aab81d9f-397d-49fb-8083-77a1872cc71f", "0fba6615-37c2-4ba6-b6e5-09599369a5bc", "d0da9dd6-c691-4614-99c7-531b0bf34837" ], "package_ndc": [ "55111-404-34", "55111-404-32", "55111-404-36", "55111-404-50", "55111-404-61", "55111-404-55", "55111-404-62", "55111-404-90", "55111-404-02", "55111-404-65", "55111-404-17", "55111-404-24", "55111-404-38", "55111-404-40", "55111-131-30", "55111-131-60", "55111-131-80", "55111-131-90", "55111-131-04", "55111-131-37", "55111-131-79", "55111-131-14", "55111-131-81", "55111-131-45", "27241-109-06", "27241-109-50", "27241-110-03", "27241-110-10", "53746-253-60", "53746-253-01", "53746-253-18", "53746-253-05", "53746-253-10", "53746-254-30", "53746-254-01", "53746-254-02", "62207-774-58", "62207-774-41", "62207-774-47", "62207-774-36", "62207-773-58", "62207-773-41", "62207-773-47", "62207-773-32", "62207-773-36", "64980-636-03", "64980-637-03", "0121-0727-16", "0121-4727-10" ], "unii": [ "BK76465IHM", "884KT10YB7" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201210" } } }, { "safetyreportversion": "4", "safetyreportid": "10008506", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20170428", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20170220", "fulfillexpeditecriteria": "1", "companynumb": "US-ACTELION-A-NJ2014-95868", "duplicate": "1", "reportduplicate": { "duplicatesource": "ACTELION", "duplicatenumb": "US-ACTELION-A-NJ2014-95868" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "46", "patientonsetageunit": "801", "patientagegroup": "5", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Sepsis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Coccidioidomycosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Pneumonia pseudomonal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Pancreatitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Drug dose omission", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Hepatomegaly", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Liver function test abnormal", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TRACLEER", "drugbatchnumb": "AP257284/DP047P0501", "drugauthorizationnumb": "021290", "drugstructuredosagenumb": "62.5", "drugstructuredosageunit": "003", "drugdosagetext": "62.5 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PULMONARY ARTERIAL HYPERTENSION", "actiondrug": "1", "activesubstance": { "activesubstancename": "BOSENTAN" }, "openfda": { "application_number": [ "NDA021290", "NDA209279" ], "brand_name": [ "TRACLEER" ], "generic_name": [ "BOSENTAN" ], "manufacturer_name": [ "Actelion Pharmaceuticals US, Inc." ], "product_ndc": [ "66215-101", "66215-102", "66215-232" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BOSENTAN" ], "rxcui": [ "349253", "352066", "656659", "656660", "1989081", "1989085" ], "spl_id": [ "f52a8c9c-529d-4bd8-9bfb-d91161935c20" ], "spl_set_id": [ "749e42fb-2fe0-45dd-9268-b43bb3f4081c" ], "package_ndc": [ "66215-101-06", "66215-101-03", "66215-102-06", "66215-102-03", "66215-232-14", "66215-232-56" ], "unii": [ "Q326023R30" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VENTOLIN HFA", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ALBUTEROL SULFATE" }, "openfda": { "application_number": [ "NDA020983" ], "brand_name": [ "VENTOLIN HFA" ], "generic_name": [ "ALBUTEROL SULFATE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0682" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "ALBUTEROL SULFATE" ], "rxcui": [ "801092", "801095", "859088", "2123076" ], "spl_id": [ "08d3613c-b059-4e06-b42c-591a129f1649" ], "spl_set_id": [ "d92c5d6b-ff10-4087-36a2-1cfc464cb967" ], "package_ndc": [ "0173-0682-20", "0173-0682-24" ], "unii": [ "021SEF3731" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CUBICIN", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugdosagetext": "500 MG, UNK", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "DAPTOMYCIN" } }, { "drugcharacterization": "2", "medicinalproduct": 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"55513-074-30", "55513-075-30" ], "unii": [ "1K860WSG25" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SPIRIVA", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "TIOTROPIUM BROMIDE MONOHYDRATE" }, "openfda": { "application_number": [ "NDA021395" ], "brand_name": [ "SPIRIVA HANDIHALER" ], "generic_name": [ "TIOTROPIUM BROMIDE" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0075" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "RESPIRATORY (INHALATION)" ], "substance_name": [ "TIOTROPIUM BROMIDE MONOHYDRATE" ], "rxcui": [ "485032", "580261" ], "spl_id": [ "94768574-0d3e-46f0-9f75-ab3c9f52857d" ], "spl_set_id": [ "820839ef-e53d-47e8-a3b9-d911ff92e6a9" ], "package_ndc": [ "0597-0075-41", "0597-0075-75", "0597-0075-47" ], "unii": [ "L64SXO195N" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DICLOFENAC", "drugstructuredosagenumb": "50", "drugstructuredosageunit": 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"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": "LIDOCAINE HYDROCHLORIDE JELLY", "drugrecurreadministration": "3" } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140402" } } }, { "safetyreportversion": "1", "safetyreportid": "10011255", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140314", "fulfillexpeditecriteria": "2", "companynumb": "US-DRREDDYS-USA/USA/13/0035242", "duplicate": "1", "reportduplicate": { "duplicatesource": "DR REDDYS", "duplicatenumb": "US-DRREDDYS-USA/USA/13/0035242" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "78", "patientonsetageunit": "801", "patientweight": "83.99", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Extra dose administered", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "No adverse event", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CETIRIZINE 10 MG", "drugbatchnumb": "7953913A", "drugauthorizationnumb": "078343", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "HYPERSENSITIVITY", "drugstartdateformat": "102", "drugstartdate": "20131021", "drugrecurreadministration": "3" }, { "drugcharacterization": "1", "medicinalproduct": "CETIRIZINE 10 MG", "drugbatchnumb": "7953913A", "drugauthorizationnumb": "078343", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "METOPROLOL SUCCINATE", "drugauthorizationnumb": "090617", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA203028", "ANDA203894", "ANDA213854", "NDA210428", "ANDA090617", "ANDA204161", "ANDA216916", "ANDA211143", "ANDA207206", "ANDA216509", "ANDA078889", "ANDA214110", "ANDA207465", "NDA019962", "ANDA204106", "ANDA203699", "ANDA205541" ], "brand_name": [ "METOPROLOL SUCCINATE", "KAPSPARGO", "TOPROL XL" ], "generic_name": [ "METOPROLOL SUCCINATE", "METOPROLOL SUCCINATE ER TABLETS" ], "manufacturer_name": [ "Nivagen Pharmaceuticals, Inc.", "Zydus Pharmaceuticals (USA) Inc.", "Epic Pharma, LLC", "Sun Pharmaceutical Industries, Inc.", "Quallent Pharmaceuticals Health LLC", "Actavis Pharma, Inc.", "Granules 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