{ "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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Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LOPERAMIDE" }, { "drugcharacterization": "2", "medicinalproduct": "IBUPROFEN", "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA074916", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA071333", "NDA020603", "ANDA076460", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", "ANDA071334", "ANDA209178", "ANDA071935", 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International, Inc.", "Retail Business Services, LLC", "Geri-Care Pharmaceutical Corp", "Dolgencorp Inc", "Cumberland Pharmaceuticals Inc.", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "FSA Store Inc. (Caring Mills)", "Spirit Pharmaceuticals LLC", "WR Group, Inc.", "BETTER LIVING BRANDS, LLC", "Rugby Laboratories, Inc.", "HART Health", "Henry Schein Inc.", "MARKSANS PHARMA LIMITED", "Topco Associates, LLC", "WALGREENS", "Publix Super Markets Inc", "SOLA Pharmaceuticals, LLC", "Meijer Distribution Inc", "Best Choice (Valu Merchandisers Company)", "TOPCO ASSOCIATES LLC", "Trifecta Pharmaceuticals USA LLC", "AMERISOURCE BERGEN", "RITE AID", "PAI Holdings, LLC dba PAI Pharma", "TOP CARE (Topco Associates LLC)", "Marc Glassman, Inc.", "Chain Drug Consortium", "RITE AID CORPORATION", "HEB", "Amneal Pharmaceuticals LLC", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "Pharmaceutical Associates, Inc.", "Amneal Pharmaceuticals NY LLC", "KROGER COMPANY", "Lil' Drug Store Products, Inc.", "PURACAP PHARMACEUTICAL LLC", "Thompson Safety", "FSA Store Inc. (Caring Mill)", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "Cardinal Health 110, LLC. DBA Leader", "Lidl US LLC", "BluePoint Laboratories", "WALMART INC.", "BETTER LIVING BRANDS LLC.", "Sam's West, Inc", "MARC GLASSMAN, INC.", "Strides Pharma Inc", "Chalkboard Health", "TIME CAP LABORATORIES, INC", "Family Dollar Services, Inc.", "BJWC (Berkley & Jensen / BJ's)", "Costco Wholesale Company", "Safeway", "RETAIL BUSINESS SERVICES,LLC.", "Discount Drug Mart", "Basic Drugs, Inc.", "Padagis Israel Pharmaceuticals Ltd", "Strides Pharma Science Limited", "AiPing Pharmaceutical, Inc.", "DEMOULAS SUPERMARKETS INC.", "ARMY AND AIR FORCE EXCHANGE SERVICE", "Belmora LLC", "The Kroger Co.", "WALGREEN CO.", "Puro Pharma Inc.", "Aurobindo Pharma Limited", "Melaleuca, Inc", "Costco Wholesale", "P & L Development, LLC", "Albertsons Companies", "Discount Drug Mart, Inc", "PROSTAT FIRST AID", "Wildman Business Group", "Unishield", "MEIJER DISTRIBUTION INC.", "Granules Pharmaceuticals Inc.", "TARGET CORPORATION", "Ascend Laboratories, LLC", "Safeway, Inc.", "CVS Pharmacy. Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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(see also WAL-MART INC)", "Cardinal Health (Leader) 70000", "Topco Associates LLC", "TOPCO ASSOCIATES LLC", "RUGBY LABORATORIES", "Retail Business Services, LLC.", "Meijer, Inc", "CVS Pharmacy, Inc.", "WALGREENS CO.", "Reliable 1 Laboratires LLC", "Care One (Retail Business Services, LLC.)", "TopCo", "RELIABLE 1 LABORATORIES", "UNITED NATURAL FOODS, INC. DBA UNFI", "CVS Pharmacy", "Good Sense (Geiss, Destin & Dunn, Inc.)", "Amerisource Bergen", "Meijer", "Marc Glassman, Inc.", "AARNA USA Inc.", "Safeway, Inc." ], "product_ndc": [ "55319-555", "53041-100", "0536-1421", "0904-7206", "69452-542", "53345-032", "72559-019", "80136-859", "83324-133", "85828-722", "80513-112", "56062-657", "67091-361", "62372-630", "82179-007", "49035-583", "79481-0608", "0363-9942", "70692-813", "69842-979", "0113-0657", "0113-0428", "84126-378", "70000-0051", "62011-0189", "11673-066", "69618-033", "11822-6080", "68163-700", "73581-301", "83059-0096", "83059-0118", "70677-1067", "0363-9888", "11673-610", "55910-797", "0067-6283", "11673-550", "0363-8970", "41520-983", "62011-0419", "84324-015", "80513-117", "55319-134", "77333-812", "36800-197", "53345-009", "11673-548", "59726-897", "79903-020", "84324-014", "59726-773", "68016-811", "37808-692", "51316-904", "53943-134", "35916-1939", "11673-549", "72288-657", "68016-670", "54738-518", "35916-1938", 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"product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIMETHICONE", "DIMETHICONE, UNSPECIFIED", "CALCIUM CARBONATE", "DIMETHACHLON" ], "rxcui": [ "198852", "314221", "252294", "314216", "412111", "198857", "809376", "2737528", "2262288", "2119393", "1741562", "1492387", "2477951", "2478331", "705156", "210299", "210295", "860055", "1537320", "2595235", "2716712", "352091" ], "spl_id": [ "b50ee474-656d-4aa4-93ae-85383f2a32ce", "7686d6a2-1def-4f14-abe2-fff152289471", "e7743400-e4a5-4817-983f-9ab81f4363a2", "449e7aee-627d-4f29-b671-1787d287ca4f", "4d7a9507-6f3d-6d15-e063-6294a90a0160", "2767f3c0-877c-60b0-e063-6394a90a8ebd", "2d566593-1510-ac0d-e063-6294a90a2f22", "b0ac7b12-53b4-4835-9094-2908645650dd", "90e2b49f-a358-4228-9b0c-130ebafd5640", "4db0a517-b466-216f-e063-6394a90aece0", "20e14e77-6853-f7d1-e063-6294a90a4487", "27f708bb-3d63-48c8-b621-e23e759f1300", "44f5b560-ba85-68eb-e063-6294a90a6f9c", "0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c", 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"65f0f72b-691f-4cbb-a5d7-7579a133f457", "0a2dc386-15b3-45a3-91d7-80b9cf202c03", "8940ec64-b0cd-4f10-bc19-251146c9e552", "634b55ef-9667-46f7-9b3e-d41f4b7b819b", "b1dd7657-05bd-4062-89f1-9e11f0042f3e" ], "spl_set_id": [ "41ac0dc1-0a71-4c69-8e25-ba838f5f16a3", "e6712877-ace0-441c-99a9-adf567c0b9a2", "db84d0ea-5c15-47f5-bbe2-8d455e75695e", "4cbc05f6-4b31-4a5f-e063-6394a90a676c", "cdd4fd12-e214-43a6-b560-d56fc0d87190", "2117af8a-723f-4e2f-98a6-83ad2c423751", "5c603ad0-9023-44cc-955c-3988d5dcf0d3", "c6436212-9246-4e29-8540-9af992b667eb", "971e5f30-55c2-4193-9dd8-b43a1862b92a", "a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6", "9c37fd25-2143-410c-8d89-d39aa5c7b453", "697e0e52-c01b-4b53-9994-f79c46eb6b4f", "3bb870d8-128d-75ea-e063-6394a90a707b", "2fb653d6-e2b2-4969-831b-c0dc37b9c0cc", "617e44f8-df80-4764-85b9-be0fb6da8db3", "ce0183b3-4410-466a-b57d-cd360d461b7c", "efb7dc02-f0c9-4537-9e23-b641c428068c", "cd8d188a-fa5d-4580-bcb1-ac8617118cbb", "e559c6c8-2973-77fb-e053-2995a90af43d", "064c6841-3ed2-417f-a77c-a730785b6036", "b1e35c97-2157-454e-967f-53a4300827de", "ccf5b124-083d-4465-a666-c1bc6e84d630", "8b1cdee5-3368-40e4-90bf-31a64df1f38a", "ef300a08-8212-40a9-847a-1b62348896dd", "acff4ff3-4435-4995-a117-dbfcdf72334a", "7e10c47d-1036-47c1-a0ed-6929636366c2" ], "package_ndc": [ "70069-005-01", "70069-005-10", "70069-172-01", "70069-172-10", "70069-172-25", "70710-1663-1", "70710-1663-7", "70710-1664-1", "70710-1664-6", "70710-1664-7", "70710-1665-1", "70710-1665-5", "55150-364-01", "55150-364-10", "55150-364-25", "87188-111-01", "87188-111-90", "87188-112-01", "87188-113-01", "68001-542-59", "68001-542-60", "69680-112-01", "69680-112-25", "69680-112-10", "69680-113-10", "69680-113-99", "69680-121-05", "69680-121-30", "69680-121-10", "68001-640-59", "68001-640-60", "71288-303-91", "71288-303-92", "45802-491-84", "0143-9621-01", "0143-9621-25", "0143-9620-01", "0143-9620-10", "0143-9619-01", "0143-9619-10", "71288-300-01", "71288-300-02", "71288-301-10", "71288-301-11", "71288-302-30", "49884-270-82", "49884-270-52", "85551-120-30", "0517-0031-01", "0517-0031-25", "0517-0032-01", "0517-0032-25", "0517-0130-01", "70069-171-05", "70069-171-10", "72603-650-01", "72603-650-25", "43386-237-70", "43386-237-60", "68083-449-25", "68083-561-25", "68083-562-01", "70512-840-01", "70512-840-25", "71288-300-91", "71288-300-92", "70756-635-10", "70756-635-25", "70756-636-25", "70756-636-10", "70756-637-05", "70756-637-88", "70756-637-10", "71288-303-01", "71288-303-02", "63323-044-41", "63323-044-44", "70771-1688-1", "70771-1688-7", "70771-1689-1", "70771-1689-6", "70771-1689-7", "70771-1690-1", "70771-1690-5", "63323-044-00", "63323-044-01", "25021-502-01" ], "nui": [ "M0022794", "N0000175951" ], "pharm_class_cs": [ "Vitamin B 12 [CS]" ], "pharm_class_epc": [ "Vitamin B12 [EPC]" ], "unii": [ "P6YC3EG204" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201203" } } }, { "safetyreportversion": "1", "safetyreportid": "10006834", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140311", "receiptdateformat": "102", "receiptdate": "20140311", "fulfillexpeditecriteria": "1", "companynumb": "20140116", "duplicate": "1", "reportduplicate": { "duplicatesource": "LUITPOLD", "duplicatenumb": "20140116" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "69", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Kounis syndrome" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Acute myocardial infarction" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "EPINEPHRINE INJECTION, USP (1071-25) 1 MG/ML", "drugstructuredosagenumb": "0.3", "drugstructuredosageunit": "003", "drugadministrationroute": "030", "drugindication": "ANAPHYLACTIC REACTION", "drugadditional": "1" }, { "drugcharacterization": "1", "medicinalproduct": "ASPIRIN", "drugdosagetext": "VARIABLE DOSING", "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 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Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DIPHENHYDRAMINE,50 MG" }, { "drugcharacterization": "2", "medicinalproduct": "FAMOTIDINE", "openfda": { "application_number": [ "ANDA218003", "ANDA077351", "ANDA075400", "ANDA206531", "ANDA215767", "ANDA215043", "ANDA217543", "ANDA078916", "ANDA075511", "ANDA091020", "ANDA206530", "ANDA075488", "ANDA075486", "ANDA201995", "ANDA217669", "ANDA217137", "ANDA215766", "ANDA215822", "ANDA075622", "ANDA075651", "ANDA215689", "ANDA075813", "ANDA090440", "ANDA217982", "ANDA217400", "ANDA216441", "ANDA077367", "NDA020325", "ANDA201695", "ANDA217529", "ANDA075805", "ANDA215630", "ANDA219863", "ANDA075591", "ANDA078642", "ANDA078641", "ANDA217330", "ANDA216400", "ANDA216427", "ANDA217605", "ANDA217655", "ANDA075718", "ANDA218181", "ANDA075709", "ANDA216030", "M001", "ANDA217842", "ANDA075302", "ANDA219091", "ANDA075786", "NDA219935" ], "brand_name": [ "FAMOTIDINE", "ACID RELIEF", "ACID 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Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALBUTEROL NEBULIZER" }, { "drugcharacterization": "2", "medicinalproduct": "METHYLPREDNISOLONE,125 MG" } ] } }, { "safetyreportversion": "1", "safetyreportid": "10006933", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessdisabling": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientweight": "105.24", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dizziness" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vertigo" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Diarrhoea" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pruritus generalised" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Gastrooesophageal reflux disease" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Condition aggravated" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "FAMOTIDINE", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 PILL ONCE DAILY TAKEN BY MOUTH", "drugadministrationroute": "048", "drugindication": "GASTROOESOPHAGEAL REFLUX DISEASE", "drugstartdateformat": "102", "drugstartdate": "20140211", "drugenddateformat": "102", "drugenddate": "20140311", "drugadditional": "2", "openfda": { "application_number": [ "ANDA218003", "ANDA077351", "ANDA075400", "ANDA206531", "ANDA215767", "ANDA215043", "ANDA217543", 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