{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 5028 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10542955", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150529", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20141024", "receiptdateformat": "102", "receiptdate": "20141024", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "12", "patientonsetageunit": "801", "patientweight": "44", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Eye swelling" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Eye disorder" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ADAPALENE.", "drugseparatedosagenumb": "-1", "drugintervaldosageunitnumb": "-1", "drugintervaldosagedefinition": "812", "drugdosagetext": "CREAM, AS NEEDED, APPLIED TO A SURFACE, USUALLY THE SKIN", "drugindication": "ACNE", "drugstartdateformat": "102", "drugstartdate": "20141022", "drugenddateformat": "102", "drugenddate": "20141023", "drugadditional": "2", "activesubstance": { "activesubstancename": "ADAPALENE" }, "openfda": { "application_number": [ "ANDA090824", "ANDA091314", "ANDA090962", "ANDA215940", "NDA021753", "NDA020748", "ANDA201000", "NDA020380", "ANDA213508", "ANDA208322", "ANDA204593" ], "brand_name": [ "ADAPALENE", "NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT", "DIFFERIN", "EFFACLAR", "PANOXYL", "PROACTIV MD ADAPALENE ACNE TREATMENT", "CURIST ACNE RELIEF", "NEUTROGENA EVENLY CLEAR RETINOID ADAPALENE GEL 0.1% ACNE TREATMENT" ], "generic_name": [ "ADAPALENE", "ADAPLANE 0.1%" ], "manufacturer_name": [ "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "TOP CARE (Topco Associates LLC)", "Walgreens", "P & L Development, LLC", "LOreal USA Products Inc", "Sun Pharmaceutical Industries, Inc.", "MEIJER, INC.", "Wal-Mart Stores Inc", "Safeway, Inc.", "Target Corporation", "GLENMARK THERAPEUTICS INC., USA", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Mayne Pharma Commercial LLC.", "Kenvue Brands LLC", "GALDERMA LABORATORIES, L.P", "CVS PHARMACY, INC", "Actavis Pharma, Inc.", "Galderma Laboratories, L.P.", "YYBA CORP", "AMERISOURCE BERGEN", "YYBA Corp", "CROWN LABORATORIES", "Topco Associates", "CVS Pharmacy", "Padagis Israel Pharmaceuticals Ltd", "Alchemee, LLC", "Cardinal Health", "Meijer Distribution Inc.", "Alembic Pharmaceuticals Inc.", "Acne Free, LLC", "RUGBY LABORATORIES, INC.", "Alembic Pharmaceuticals Limited", "RITE AID", "CALL INC. (dba Rochester Pharmaceuticals)", "The Kroger Co.", "Little Pharma, Inc." ], "product_ndc": [ "0168-0424", "36800-088", "0363-1401", "59726-888", "49967-354", "51672-2150", "41250-288", "79903-338", "21130-708", "82442-105", "72657-158", "55910-880", "68308-666", "69968-0826", "0299-5915", "51316-114", "49967-591", "0472-0126", "0299-4910", "59726-114", "73581-214", "46122-768", "49967-592", "0363-4110", "73581-019", "0299-5918", "0316-0143", "76162-114", "69842-088", "45802-453", "11410-958", "21130-754", "70000-0666", "79481-1140", "73581-215", "62332-549", "80861-115", "0536-1412", "0316-0284", "46708-549", "51672-1377", "11822-0062", "49908-118", "30142-725", "73581-216", "0363-0888", "72559-015", "69968-0945" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "ADAPALENE" ], "rxcui": [ "313852", "307731", "722111", "284420", "153183", "722113", "798061" ], "spl_id": [ "3704e230-6ad8-448d-a4bf-a86c449837b9", 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"0363-1401-05", "59726-888-05", "49967-354-02", "49967-354-01", "51672-2150-1", "51672-2150-6", "41250-288-05", "79903-338-05", "21130-708-05", "82442-105-01", "72657-158-17", "72657-158-55", "55910-880-05", "68308-666-45", "68308-666-25", "69968-0826-1", "0299-5915-45", "51316-114-16", "51316-114-05", "49967-591-02", "49967-591-01", "0472-0126-45", "0299-4910-45", "0299-4910-15", "0299-4910-00", "0299-4910-10", "0299-4910-40", "59726-114-05", "73581-214-06", "46122-768-36", "49967-592-02", "49967-592-01", "0363-4110-16", "0363-4110-05", "73581-019-06", "0299-5918-45", "0299-5918-25", "0299-5918-15", "0299-5918-02", "0316-0143-15", "76162-114-05", "69842-088-16", "69842-088-05", "45802-453-84", "11410-958-45", "11410-958-15", "21130-754-05", "70000-0666-1", "70000-0666-2", "79481-1140-5", "73581-215-45", "62332-549-15", "62332-549-45", "62332-549-46", "72657-158-15", "72657-158-45", "80861-115-01", "0536-1412-20", "0536-1412-26", "0316-0284-15", "46708-549-15", "46708-549-45", "46708-549-46", "51672-1377-6", "51672-1377-9", "11822-0062-1", "49908-118-00", "49908-118-14", "30142-725-05", "73581-216-45", "0363-0888-05", "0363-0888-16", "72559-015-13", "72559-015-17", "69968-0945-2" ], "nui": [ "N0000175607", "M0018962" ], "pharm_class_epc": [ "Retinoid [EPC]" ], "pharm_class_cs": [ "Retinoids [CS]" ], "unii": [ "1L4806J2QF" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20141023" } } } ] }