{ "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": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 48643 } }, "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", "ANDA040433", "ANDA205318", "ANDA217117", "NDA017584", "ANDA206463", "NDA020612", "ANDA080407", "NDA207962", "part348", "ANDA080198", "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%", "STUD 100 MALE GENITAL DESENSITIZER", "DISCOUNT DRUG MART PAIN RELIEF PATCHES", "THERACARE LIDOCAINE PAIN RELIEF", "PAINLESS TATTOO 2", "DOLLAR GENERAL PAIN RELIEVING PATCH WITH LIDOCAINE", "VBBV NUMBING", "BIG TOE JOINT PAIN RELIEF PATCH", "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", "ACOLYE NUMBING CREAM ANORECTAL(HEMORRHOIDAL) CREAM", "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", "DEALMED BURN", "LIDOCAINE PAIN RELIEF GEL -PATCH", "ZCAINE FAST ACTING ANESTHETIC", "CARELAND PAIN RELIEF PATCH PLUS", "FOSTER AND THRIVE", "DR. 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SCHOLLS BLISTER PAIN RELIEF COMPLETE KIT", "NUMB FAST HEMORRHOIDAL", "FLANAX BACK PAIN RELIEF", "MAXIMUM STRENGTH PAIN RELIEF LIDOCAINE PATCH", "RECTAEASE HEMORRHOID RELIEF CREAM", "CURIST LIDOCAINE MAXIMUM STRENGTH", "LMX4", "HONEST MED LIDOCAINE PAIN RELIEF PATCH", "BUNNIES BUM HEMORRHOIDAL NUMBING", "ADELLINA NUMBING CREAM", "VBBV ANORECTAL(HEMORRHOIDAL) CREAMS", "DESERT HARVEST RELEVEUM", "PLUM SMOOTH PLUMB NUMB GELEE", "SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX", "MEIJER LIDOCAINE PAIN RELIEF PATCH ASSORTMENT MEDIUM", "SYNTHERMA PLUS", "LIDOXRYL", "MYDERM MEDICAL 5 LIDOCAINE NUMBING ROLL-ON", "THERACARE PAIN RELIEF 4% LIDOCAINE", "PROLAYED", "ANIEVALC", "THERA CARE PAIN THERAPY", "XESSO STRAWBERRY REAR COMFORT GLIDE 4% LIDOCAINE", "THERACARE PAIN RELIEVING PATCH WITH LIDOCAINE", "ASPERCREME WITH LIDOCAINE DRY", "BIOFREEZE ULTRAFLEX", "PAIN RELIEF PATCH 4% LIDOCAINE", "VBBV TATTOO NUMBING", "LIDOCAINE KNEE PAIN RELIEF GEL-PATCH", "LIDOCAINE ANORECTAL", "ASSIELF NUMBING TOPICAL ANORECTAL", "MAXIMUM STRENGTH 4% LIDOCAINE PATCH GOOD NEIGHBOR PHARMACY", "GOOD NEIGHBOR PAIN RELIEF PATCH WITH LIDOCAINE 4%", "THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH", "BURN EASE COOLING", "LEADER BURN RELIEF", "PAIN RELIEF PATCH LIDOCAINE", "PAIN RELIEVEING GEL-PATCH", "THERACARE FLEXIBLE PAIN RELIEVING", "ASPERCREME WITH LIDOCAINE", "MEIJER LIDOCAINE PAIN RELIEF PATCH ASSORTMENT LARGE", "AMAZON BASICS PAIN RELIEF PATCH WITH 4% LIDOCAINE", "GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK", "ASSURED BIKINI SMOOTH CREAM", "BACTINE MAX LIDOCAINE ROLL-ON 2.5OZ", "BLOOP FISSURE HEALING ANORECTAL TOPICAL", "TATTOO NUMBING CREAM", "LIDOCAINE ROLL-ON", "ADELLINA LIDOCAINE NUMBING CREAM TOPICAL ANORECTAL CREAM", "LAIYINHE NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM", "HEALCOME LIDOCAINE NUMBING CREAM", "HEMPVANA ULTRA STRENGTH PAIN RELIEF - OVERNIGHT", "EJAGUARD", "EQUATE PAIN RELIEVING CREAM LIDOCAINE", "CARELAND KINESIOLOGY DUAL ACTION PAIN RELIEVING TAPE", "BACTINE MAX ANTIBIOTIC AND LIDOCAINE MAX PAIN RELIEF", "CARELAND LIDOCAINE PAIN RELIEVING", "JO FOR HIM PROLONGER WITH LIDOCAINE", "MEIJER LIDOCAINE PAIN RELIEF BACK AND LARGE AREAS", "WALGREENS SUNBURN RELIEF", "LIDOCAINE NUMBING CREAM", "CURIST LIDOCAINE PATCH MAXIMUM STRENGTH", "BURN", "CVS HEALTH XL LIDOCAINE PAIN RELIEF", "MEIJER PAIN RELIEF CREAM", "LIDOTRODE", "BLACK COBRA TATTOO NUMBING CREAM 4% LIDOCAINE", "PAIN RELIEF GEL-PATCH", "CVS PAIN-RELIEVING", "HUSH ANESTHETIC", "ALBERTSONS PAIN RELIEF PATCH", "RITE AID LIDOCAINE PATCH XLARGE", "BUNNIES BUM ANORECTAL NUMBING", "LIDOCAINE PAIN RELIEF PATCHES", "RELIEVE A PAIN", "PROSTAT FIRST AID BURN EASE, 0.9G", "WALGREENS LIDOCAINE BACK", "ZENSA", "PAIN AND ITCH RELIEF 4% LIDOCAINE", "MEDLOT PAIN RELIEF GEL PATCH", "QUALITY CHOICE LIDOCAINE PAIN RELIEF PATCH", "LIDOCAINE CREAM, 4%", "AUVON PAIN RELIEF ROLL-ON", "LIDOCAINE PAIN RELIEF", "FAST FREEZE LIDOCAINE", "LMX5", "QUICK NUMB", "TYLENOL PRECISE PAIN RELIEVING LIDOCAINE 4%", "LEADER PAIN RELIEF PATCHES", "PAIN RELIEF GEL-ROLL ON", "PAIN FREE IV", "HEALTHWISE MAXIMUM PAIN RELIEF", "HEMAWAY", "HEMRID ANORECTAL CREAM", "HEMORRHOID PAIN RELIEF", "WELMATE LIDOCAINE PAIN RELIEVING PATCH", "DCSILY NUMBING CREAM", "SALONPAS LIDOCAINE PAIN RELIEVING", "CURIST HEMORRHOID RELIEF", "ARTHCAL 4% LIDOCAINE GEL PATCHES", "LIDOCAINE PAIN-RELIEVING PATCH", "LIDOCAINE 4 PERCENT", "ZTLIDO", "NUMB PLUS MAXIMUM STRENGTH ANORECTAL", "DR. 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[ "N0000175682", "M0000897", "N0000175426", "N0000175976", "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417", "N0000175683", "M0007766" ], "pharm_class_epc": [ "Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]", "Non-Standardized Chemical Allergen [EPC]", "Ester Local Anesthetic [EPC]" ], "pharm_class_cs": [ "Amides [CS]", "Allergens [CS]", "Glycerol [CS]", "Esters [CS]" ], "pharm_class_pe": [ "Local Anesthesia [PE]", "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]" ], "unii": [ "98PI200987", "V13007Z41A", "EC2CNF7XFP", "4T6H12BN9U", "PDC6A3C0OX", "04JA59TNSJ", "30Q7KI53AK", "L7T10EIP3A", "89Y4M234ES", "19371312D4", "F5UM2KM3W7", "0619F35CGV", "046O35D44R" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CIDEX", "drugauthorizationnumb": "203040", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "1", "medicinalproduct": "PROPOFOL (PROPOFOL)", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" } ] } } ] }