{ "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": 54080 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10006453", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140311", "receiptdateformat": "102", "receiptdate": "20140318", "fulfillexpeditecriteria": "1", "companynumb": "AUR-APL-2014-02353", "duplicate": "1", "reportduplicate": { "duplicatesource": "AUROBINDO", "duplicatenumb": "AUR-APL-2014-02353" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "44", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Anaphylactoid reaction" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LIDOCAINE", "drugauthorizationnumb": "203040", "drugadministrationroute": "058", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "505G(a)(3)", "M017", "M015", "ANDA088586", "ANDA040911", "ANDA206297", "ANDA206498", "ANDA200675", "M016", "ANDA088390", "ANDA088389", "ANDA211469", "ANDA086724", "ANDA210958", "ANDA217117", "NDA017584", "ANDA206463", "NDA020612", "ANDA080407", "NDA207962", "part348", "ANDA080198", "ANDA040433", "NDA215029", "ANDA211697", "M", "ANDA212695" ], "brand_name": [ "LIDOCAINE PAIN RELIEF GEL-PATCH", "BLACK COBRA TATTOO NUMBINGSPRAY 4% LIDOCAINE", "PAIN RELIEF", "AIPATCH NUMBING PAIN RELIEF", "INVIGOR OH", "UNIVERSAL PAIN RELIEF", "LIDOCAINE", "LIDOCAINE 5%", "DISCOUNT DRUG MART PAIN RELIEF PATCHES", "THERACARE LIDOCAINE PAIN RELIEF", "PAINLESS TATTOO 2", "DOLLAR GENERAL PAIN RELIEVING PATCH WITH LIDOCAINE", "CORALITE ODOR FREE PAIN RELIEF", "PAIN RELIEF PATCHES", "KY DURATION FOR HIM", "PAIN RELIEVING LIDOCAINE PATCH", "NUMB MASTER", "NUMB 520", "PAIN RELIEVING GEL-PATCH", "ELEMAR PATCH", "WALMART EQUATE ALOE SUNBURN RELIEF COOLING", "MAXIMUM STRENGTH LIDOCAINE PATCH", "RUGBY PAIN RELIEF PATCHES", "CVS HEMORRHOIDAL LIDOCAINE 5 RAPID PAIN RELIEF WITH 10 FINGER COTS", "HUNTER BEACH 4%", "MAXOCAINE TOPICAL ANESTHETIC ANORECTAL", "CVS 9083 MAXIMUM STRENGTH LIDOCAINE 4 PAIN RELIEF PATCH 1CT LARGE", "CVS PAIN RELIEF LIDOCAINE XL", "MEIJER PAIN RELIEF PATCHES", "ASPERCREME WITH LIDOCAINE XL", "ASPERCREME LIDOCAINE XL", "PAIN RELIEF 4% LIDOCAINE", "PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE", "DYNAMO DELAY SAMPLE BOTTLE", "NATURAL SEAL ITCH RELIEF FOR KIDS", "LIDOCAINE PAIN RELIEF GEL -PATCH", "ZCAINE FAST ACTING ANESTHETIC", "CARELAND PAIN RELIEF PATCH PLUS", "FOSTER AND THRIVE", "DR. 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