{ "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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"212549", "212575", "308135", "308136" ], "spl_id": [ "643fa1a0-53d9-4ce8-bc04-44285b006997", "3714a872-b6c6-4d74-88d2-add8a895e311" ], "spl_set_id": [ "7367289c-b0b0-466a-83e2-558e2985c29f", "abd6a2ca-40c2-485c-bc53-db1c652505ed" ], "package_ndc": [ "58151-353-77", "58151-354-77", "58151-354-88", "58151-354-30", "58151-355-77", "58151-355-88", "0069-1520-68", "0069-1530-68", "0069-1530-41", "0069-1530-72", "0069-1540-68", "0069-1540-41" ], "unii": [ "864V2Q084H" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140110" } } }, { "safetyreportversion": "1", "safetyreportid": "10004126", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-TEVA-465544ISR", "duplicate": "1", 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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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Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Strides Pharma Inc.", "Pioneer Life Sciences, LLC", "Wal-Mart Stores Inc", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Grocery Outlet, Inc.", "Randob Labs., Ltd.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Amneal Pharmaceuticals of New York LLC", "Winco Foods, LLC", "Walgreens", "Pharmadel LLC", "RETAIL BUSINESS SERVICES , LLC.", "PureTek Corporation", "CHAIN DRUG MARKETING ASSOCIATION INC", "Lil Drug Store Products, Inc", "H E B", "Live Betr LLC", "Softgel Healthcare Private Limited", "United Natural Foods, Inc. dba UNFI", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Granules India Limited", "Guardian Drug Company", "WINCO FOODS, LLC", "NorthStar Rx LLC", "Major Pharmaceuticals", "Topco Associates LLC", "Dolgencorp, LLC", "Allegiant Health", "Walgreen Company", "Care One (American Sales Company)", "L.N.K. 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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EXTRA STRENGTH", "PEPTO GAS PLUS BLOATING", "CARDINAL HEALTH INFANTS GAS RELIEF", "GAS RELIEF - CHERRY FLAVOR", "SIMETHICONE 80 MG", "GAS RELIEF EXTRA STRENGTH", "MAXIMUM STRENGTH GAS RELIEF", "UP AND UP EXTRA STRENGTH GAS RELIEF CHEWABLES EXTRA STRENGTH", "GAS-X MAXIMUM STRENGTH SOFTGELS", "GAS RELIEF SIMETHICONE 180MG SOFTGEL", "FAMILY WELLNESS EXTRA STRENGTH GAS RELIEF CHERRY", "SIMETHICONE 80MG", "TARGET GAS RELIEF CHEWS MIXED BERRY AND STRAWBERRY", "GAS RELIEF SIMETHICONE 125MG SOFTGEL", "GAS RELIEF ULTRA STRENGTH", "PREMIER VALUE EXTRA STRENGTH", "EXTRA STRENGTH GAS RELIEF CHERRY", "GAS RELIEF ANTI-GAS", "EXTRA STRENGTH GAS RELIEF CHERRY FLAVOR", "BASIC CARE GAS RELIEF", "PREMIER VALUE INFANTS GAS RELIEF", "QUALITY CHOICE INFANTS DYE FREE GAS RELIEF", "MAXIMUM STRENGTH GAS RELIEF SOFTGEL", "BEST CHOICE EXTRA STRENGTH", "TEENY TUMMY GAS RELIEF DROPS", "ANTI-GAS ULTRA STRENGTH", "INFANT GAS RELIEF", "EXTRA STRENGTH SIMETHICONE", "PHAZYME ULTIMATE", "CURIST GAS RELIEF", "QUALITY CHOICE MAXIMUM STRENGTH GAS RELIEF SOFTGEL", "HEB GAS RELIEF EXTRA STRENGTH PEPPERMINT", "QUITA COLICOS GAS RELIEF DROPS", "GAS-AID DROPS FOR INFANTS", "FEVIA GAS CONTROL", "INFANTS GAS RELIEF DROPS", "LEADER GAS RELIEF", "QC GAS RELIEF MINT FLAVOR", "CVS HEALTH GAS RELIEF SOFTGEL", "HEB ANTI GAS EXTRA STRENGTH", "MYLANTA GAS", "QUALITY CHOICE GAS RELIEF EXTRA STRENGTH SOFTGELS", "SIMETHICONE GAS RELIEF", "ANTI-GAS", "FOSTER AND THRIVE INFANTS GAS RELIEF", "CARE ONE GAS RELIEF", "MEIJER EXTRA STRENGTH GAS RELIEF", "MEIJER INFANTS GAS RELIEF DROPS", "AMAZON EXTRA STRENGTH", "ANTI-GAS STRIP", "GAS-X EXTRA STRENGTH SOFTGELS", "WALGREENS INFANTS DYE FREE GAS RELIEF", "RUGBY GAS RELIEF", "MEIJER EXTRA STRENGTH GAS RELIEF SOFTGEL", "EXTRA STRENGTH GAS RELIEF CHERRY CREME", "CVS HEALTH ANTI GAS", "WINCO FOODS GAS RELIEF EXTRA STRENGTH SOFTGELS", "MYLANTA GAS MINIS MINT FLAVOR", "GAS-X EXTRA STRENGTH", "PUBLIX EXTRA STRENGTH", "MEIJER ULTRA STRENGTH GAS RELIEF SOFTGEL", "MYLICON INFANTS GAS 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"SIMETHICONE INFANT GAS RELIEF DROPS", "DISCOUNT DRUGMART GAS RELIEF EXTRA STRENGTH SOFTGELS" ], "generic_name": [ "SIMETHICONE", "TARGET BERRY BLAST ANTACID HBG CHEW" ], "manufacturer_name": [ "Family Dollar (FAMILY WELLNESS)", "Guardian Drug Company", "Rugby Laboratories, Inc.", "Major Pharmaceuticals", "BIONPHARMA INC.", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.", "Little Pharma, Inc.", "Heartland Pharma Co.", "Chain Drug Marketing Association Inc.", "Grocery Outlet, Inc.", "Advanced Rx LLC", "Publix Super Markets Inc", "WINCO FOODS, LLC", "Infirst Healthcare", "Mollec Inc", "Wal-Mart Stores Inc", "Meijer Distribution, Inc.", "Walgreen Co.", "Strive Pharmaceuticals Inc.", "CVS PHARMACY", "L. 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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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IBUPROFEN", "IBUPROFEN CA", "DYE-FREE IBUPROFEN 200", "IBUPROFEN 100", "IBUPROFEN 250", "INFANTS IBUPROFEN", "IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER", "CARE ONE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION, BUBBLE GUM", "GREEN GUARD IBUPROFEN RELIEF", "KIRKLAND SIGNATURE IBUPROFEN IB", "PEDIACARE CHILDRENS IBUPROFEN BERRY", "GOOD SENSE IBUPROFEN INFANTS", "INFANTS ADVIL", "CIRCLE K IBUPROFEN", "IBUPROFEN INFANTS DROPS", "CVS IBUPROFEN", "SIGNATURE CARE IBUPROFEN", "PARENTS CHOICE INFANTS IBUPROFEN", "LEADER INFANTS IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS", "TOPCARE INFANTS IBUPROFEN", "GOODNOW PAIN RELIEF", "CHILDRENS IBUPROFEN 100 DYE FREE", "FLEX-PRIN", "PAIN RELIEF - IBUPROFEN 200 MG", "DIRECT SAFETY IBUPROFEN", "IBUPROFEN, LIL DRUG STORE", "MEDIQUE AT HOME IPRIN", "IBUPROFEN FAST RELIEF MEDICINE FOR PAIN", "MIGRAINE RELIEF", "LIL DRUG STORE IBUPROFEN", "MCKESSON IBUPROFEN 200 MG", "IBUWIN FORTE", "IBUPROFEN 200", "DG HEALTH CHILDRENS IBUPROFEN", "IBUPROFEN, CIRCLE K, 50CT", "IBUPROFEN, CASEYS, 50CT", "IBUPROFEN, LIL DRUG STORE, 50CT", "IBUPROFEN, LIL DRUG STORE, 24CT", "MOTRIN IB, TRAVEL BASIX", "MOTRIN IB, CVP HEALTH", "365 WHOLE FOODS MARKET IBUPROFEN", "CAREALL IBUPROFEN", "GOOD SENSE INFANTS IBUPROFEN", "VALUMEDS IBUPROFEN", "DOLEX CHILDREN", "IBUPROFEN DYE-FREE", "MOTRIN IB MIGRAINE", "FAST PAIN RELIEF", "FOSTER AND THRIVE INFANTS IBUPROFEN" ], "generic_name": [ "IBUPROFEN", "IBUPROFEN CAPSULES 200 MG", "IBUPROFEN TABLETS USP, 200MG", "IBUPROFEN TABLET, FILM COATED", "IBUPROFEN ORAL", "IBUPROFEN 200MG", "IBUPFROFEN", "IBUPROFEN TABLET, FILM-COATED", "IBUPROFEN 200 MG", "IBUPROFEN CAPSULE" ], "manufacturer_name": [ "DOLGENCORP INC", "American Sales Company", "Strive Pharmaceuticals Inc.", "Rite Aid Corporation", "Dolgencorp, Inc.", "HyVee Inc", "Best Choice", "Harris Teeter", "Kroger Company", "Cardinal Health 110, LLC. dba Leader", "PuraCap Pharmaceutical LLC", "NUVICARE LLC", "Geritrex LLC", "L. Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Strides Pharma Inc.", "Pioneer Life Sciences, LLC", "Wal-Mart Stores Inc", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Grocery Outlet, Inc.", "Randob Labs., Ltd.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Amneal Pharmaceuticals of New York LLC", "Winco Foods, LLC", "Walgreens", "Pharmadel LLC", "RETAIL BUSINESS SERVICES , LLC.", "PureTek Corporation", "CHAIN DRUG MARKETING ASSOCIATION INC", "Lil Drug Store Products, Inc", "H E B", "Live Betr LLC", "Softgel Healthcare Private Limited", "United Natural Foods, Inc. dba UNFI", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Granules India Limited", "Guardian Drug Company", "WINCO FOODS, LLC", "NorthStar Rx LLC", "Major Pharmaceuticals", "Topco Associates LLC", "Dolgencorp, LLC", "Allegiant Health", "Walgreen Company", "Care One (American Sales Company)", "L.N.K. 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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