{ "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": 1 } }, "results": [ { "safetyreportid": "6721407-3", "transmissiondateformat": "102", "transmissiondate": "20101027", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20100426", "receiptdateformat": "102", "receiptdate": "20091209", "fulfillexpeditecriteria": "2", "companynumb": "2009BI038639", "primarysource": { "reportercountry": "UNITED STATES", "qualification": "3" }, "sender": { "senderorganization": "FDA-Public Use" }, "receiver": null, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddrapt": "CHEST PAIN" }, { "reactionmeddrapt": "MULTIPLE SCLEROSIS RELAPSE" }, { "reactionmeddrapt": "MUSCLE SPASMS" }, { 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"openfda": { "application_number": [ "NDA020397", "NDA021447", "ANDA213798" ], "brand_name": [ "ZANAFLEX" ], "generic_name": [ "TIZANIDINE HYDROCHLORIDE" ], "manufacturer_name": [ "Covis Pharma US, Inc", "Legacy Pharma USA, Inc.", "Trifluent Pharma, LLC" ], "product_ndc": [ "70515-594", "70515-602", "70515-604", "70515-606", "83107-001", "83107-002", "83107-003", "83107-004", "73352-090" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "TIZANIDINE HYDROCHLORIDE" ], "rxcui": [ "153735", "313413", "485484", "485485", "485486", "580267", "583165", "583211", "2723708", "2723710" ], "spl_id": [ "3468e009-cfd1-f217-e063-6294a90a1429", "476ae6e6-0732-af36-e063-6394a90a7c02", "4007fbf6-8eb7-85e9-e063-6394a90a4013" ], "spl_set_id": [ "043d9e51-bfa2-4add-9058-5ece332f7e99", "60c27d35-7349-4fc6-86ad-70fffdbe3e08", "9833a1b8-f530-4a06-bc77-7d11b6e94c65" ], "package_ndc": [ "70515-602-15", "70515-604-15", "70515-606-15", "70515-594-15", "83107-001-15", "83107-002-15", "83107-003-15", "83107-004-15", "73352-090-60" ], "unii": [ "B53E3NMY5C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PHENERGAN", "openfda": { "application_number": [ "ANDA083312" ], "brand_name": [ "PHENERGAN" ], "generic_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0641-6082", "0641-6083", "0641-6084", "0641-6085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "rxcui": [ "992460", "992462", "992858", "992876" ], "spl_id": [ "a64f0625-8d56-4994-8908-13614ca7b09f", "7d6e64fc-bbf2-4ea9-b866-8115c448e687" ], "spl_set_id": [ "6f7e47cc-f823-4336-8107-f980e3049617", "481866da-a712-48a5-853f-8e84aacaab6d" ], "package_ndc": [ "0641-6082-01", "0641-6082-25", "0641-6083-01", "0641-6083-25", "0641-6084-01", "0641-6084-25", "0641-6085-01", "0641-6085-25" ], "unii": [ "R61ZEH7I1I" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LIDOCAINE", "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. NUMB", "RECTOPROTECT", "LIDOCORE", "CVS PAIN RELIEF", "LIDOXI", "LIDOCAINE 4% PATCH", "4 LIDOCAINE TOPICAL ANESTHETIC", "CURIST HEMORRHOID FISSURE RELIEF", "MAXIMUM STRENGTH 4% LIDOCAINE PATCH", "LIDOCAINE PATCH", "GNIBY LIDOCAINE ANORECTAL HEMORRHOIDAL NUMBING", "LMR PLUS", "CARELAND X-LARGE LIDOCAINE 4 PAIN RELIEVING", "MEIJER LIDOCAINE PAIN RELIEF PATCH ASSORTMENT SMALL", "GREENCAINE BLAST", "BIKINI ZONE MEDICATED GEL", "NUMB25", "NUMBING CREAM", "ADELLINA LIDOCAINE NUMBING CREAM ANORECTAL(HEMORRHOIDAL) CREAM", "GOODSENSE PAIN RELIEF", "ASPERCREME WITH LIDOCAINE ESSENTIAL OILS ROSEMARY MINT", "PAIN PATCH PERFECTO 24 HOURS LIDOCAINE 4 % PATCH", "MAXIMUM STRENGTH HEMORRHOIDAL RELIEF", "OCEAN POTION SUNCARE ICE PLUS PAIN RELIEVING SOOTHING", "BURN RELIEF", "NUMBING", "PUREGEN LABS PAIN RELIEF 4 LIDOCAINE", "WALGREENS LIDOCAINE KNEE AND ELBOW", "SIGNATURE CARE ALOE VERA GEL WITH LIDOCAINE", "LIDOCAINE PAIN RELIEVING GEL-PATCH", "PAIN RELIEVING", "LIDOCAINE PAIN RELIEF PATCH", "MYDERM", "ALIVIO", "OTC RESCUE LIDOCAINE PAIN RELIEF PATCH", "5% SIGNATURE NUMB CREAM", "NUMB AND NUMBER ANORECTAL CREAM", "FOOT AND LEG PAIN RELIEF", "MYDERM ALOE AND LIDOCAINE", "DR. 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", "NERANTE NUMBING CREAM", "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. SCHOLLS BLISTER PAIN RELIEF COMPLETE", "DR REAL NUMB TOPICAL ANORECTAL", "DR. CARE NUMBING CREAM", "FL BURN EASE, 0.9G", "CURIST LIDOCAINE NUMBING RELIEF", "FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL", "HEMPVANA ULTRA STRENGTH PAIN RELIEF", "WALGREENS EXTRA SMALL LIDOCAINE", "NEUROCAINE", "MEDINUMB", "THE SOLUTION 2.0", "CARELAND MAX STRENGTH LIDOCAINE 4 PAIN RELIEVING", "DEEVEEANT NUMB", "RWWXII DEEP NUMBING CREAM(ANORECTAL HEMORRHOIDAL CREAM)", "WALGREENS LIDOCAINE PAIN RELIEVING PATCH ASSORTED", "STEADY FREDDY", "XESSO REAR COMFORT GLIDE", "HEMPVANA MAXIMUM STRENGTH PAIN RELIEF TOPICAL ANESTHETIC", "CVS HEALTH LIDOCAINE PAIN-RELIEVING", "MEDLINE", "5% DR.CARE NUMB CREAM", "LIDOCAINE PLANTAR RELIEF ROLL-ON", "LIDOCAINE PAIN RELIEF PATCH 6 CT", "BONICAEASEX PAIN RELIEVING LIDOCAINE", "MAXIMUM STRENGTH HEMORRHOIDAL RELIEF WITH FINGER COTS", "TOPCARE PAIN RELIEF PATCHES", "RELIVYX PLUS", "BONDLIDO", "LIDO KING LIDOCAINE 4% PAIN RELIEVING GEL-PATCH", "BIKINI ZONE MEDICATED CREME", "MUSCLE AND JOINT CARE", "SUMIFUN LIDOCAINE PAIN RELIEF GEL-PATCH", "EQUATE HEMORRHOID RELIEF", "LIDOCAINE KNEE PAIN RELIEF PATCH", "FOOT PAIN RELIEF PADS", "SINSINPAS LIDOCAINE PAIN RELIEVING", "DERMACINRX PHN PAK", "LIDOCAINE 4% CREAM", "ASPERCREME", "4% LIDOCAINE MAXIMUM STRENGTH PAIN RELIEF", "PAIN RELIEF LIDOCAINE", "WALGREENS PAIN RELIEVING LIDOCAINE PATCH", "BACTINE MAX BANDAGE", "CVS HEALTH LIDOCAINE PAIN RELIEF", "CARELAND LIDOCAINE 4 PAIN RELIEVING GEL-PATCHES", "LIDOCAINE DRY", "TYLENOL PRECISE WARMING PAIN RELIEVING", "NUMBSKIN MAXIMUM STRENGTH PAIN RELIEVER", "MAXIMUM STRENGTH 4% LIDOCAINE PATCH HEALTHA2Z", "LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF", "BRAZZERS ANAL DESENSITIZING", "ORYTHIA PAIN RELIEVING LIDOCAINE", "VEIURKIU EXTERNAL ANALGESIC CREAM", "WALGREENS PAIN RELIEVING LIDOCAINE", "MAXIMUM STRENGTH 4% LIDOCAINE PATCH LEADER", "ZMZTUHUA NUMBING CREAM", "BED BUG INSTANT BITE RELIEF", "CVS HEALTH LIDOCAINE CREAM", "LIDOCANNA", "LIDAFLEX", "LIDOCAINE 4%", "CHINESE RED TIGER LIDOCAINE PATCHES", "SIGNATURE CARE MEDICATED PAIN RELIEF PATCH", "DYNAMO DELAY", "LIDOCAINE PAIN RELIEF GEL ROLL-ON", "MICROCAINE TOPICAL ANALGESIC", "CRANE SAFETY BURN", "LIDOCAINE 5% CREAM", "RECTICARE", "SPARTAN", "MOROVAN", "SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF", "ADVANCED SEAL BARRIER PLUS PAIN RELIEF", "PROLAYED LIDOCAINE MALE GENITAL DESENSITIZER", "FLARESTOP HEMORRHOID LIDOCAINE", "HILOOK NUMBING CREAM", "LIDFIX PAIN RELIEF PATCH LIDOCAINE", "ELSE.", "SIGNATURE CARE LIDOCAINE CREAM", "NUMB520", "BACTINE MAX", "KROGER PAIN RELIEF LIDOCAINE PATCH", "RETALIEF LIDOCAINE 5", "ARTHCAL 4% LIDOCAINE PATCHES", "AUVON PAIN RELIEF CREAM", "ORYTHIA MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING", "LIGHTNING X BURN", "HILOOK BLUE GEL ANESTHETIC", "CINTHERA", "PAIN RELIEVING PATCH", "GEMBOOXT TOPICAL NUMBING CREAM", "ETADERM NUMBING CREAM", "EQUATE SUNBURN RELIEF WITH ALOE AFTER SUN", "SONACAINE TOPICAL ANESTHETIC WITH MENTHOL", "HEALTHWISE LIDOCAINE PAIN RELIEF", "TYLENOL PRECISE PAIN RELIEVING", "ASPER FLEX", "POMG PAIN RELIEF 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"Perrigo Direct", "Glenmark Pharmaceuticals Inc., USA", "InterMed Laboratories Private Limited", "Clinical Resolution Laboratory, Inc.", "PHARMACURE LLC", "Ebanel Laboratories, Inc", "V2 Pharma, LLC", "WAL-MART STORES INC.", "Guangdong Aimu Biological Technology Co., Ltd", "RUGBY LABORATORIES", "CVS PHARMACY, INC", "HUNTERS BEACH LIFE", "PRIME COMMERCE, LLC", "CVS Pharmacy", "YYBA Corp", "Meijer Distribution Inc", "Chattem, Inc.", "Lead Chemical Co., Ltd.", "Unexo Life Sciences Private Limited", "Advanced Rx LLC", "Momentum Management LLC", "Kericure Inc.", "Dealmed Medical Supplies, LLC.", "Shaanxi Shuvita Biotech Co., Ltd", "Actavis Pharma, Inc.", "PHI, Inc", "Planet (Anhui) Pharmaceutical Co., Ltd.", "STRATEGIC SOURCING SERVICES, LLC", "Shinpharma Inc", "Akron Pharma Inc.", "iON Pharma, LLC", "T&T Pharma Holdings LLC", "Aldermed Inc.", "Northstar Rx LLC", "Little Pharma, Inc", "Solis Pharmaceuticals Inc.", "Shenzhen Finona Information Technology Co., Ltd", "Putian Licheng District 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"Proper Buys LLC", "FloCal Distributors LLC", "Jiashen International Trading Co., Ltd.", "Desert Harvest Inc.", "Universal Companies, Inc.", "Hisamitsu Pharmaceutical Co., Inc.", "PureTek Corporation", "Inspec Solutions", "Belmora LLC", "MATRIX MIXOLOGY, INC", "Blackstone Products, LLC", "Premium Natural Cosmetics Inc", "Alembic Pharmaceuticals Inc.", "Reliable 1 Laboratories LLC", "Patrin Pharma, Inc", "Shenzhen Yuanbang International Logistics Co., Ltd", "Golden State Medical Supply, Inc.", "ProStat First Aid LLC", "Cardinal Health", "Alembic Pharmaceuticals Limited", "HyVee", "Bullet point LLC", "Sainite Trading Shenzhen Co., Ltd.", "Shenzhen Wankelai E-commerce Co., Ltd.", "Marlex Pharmaceuticals Inc", "STRATUS PHARMACEUTICALS INC", "Sentiss Pharmaceuticals LLC", "Amazon.com Services LLC", "Geri-Gentle Corporation", "Encube Ethicals, Inc.", "Zhejiang Jingwei Pharmaceutical Co., Ltd.", "WellSpring Pharmaceutical Corporation", "Three Nations Corp", "WALMART INC.", "BLOOMWELL GARDENS 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