{ "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": [ { "safetyreportversion": "1", "safetyreportid": "18954528", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20210420", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20210301", "receiptdateformat": "102", "receiptdate": "20210301", "fulfillexpeditecriteria": "1", "companynumb": "US-GW PHARMA-202102USGW00654", "duplicate": "1", "reportduplicate": { "duplicatesource": "GW PHARMA", "duplicatenumb": "US-GW PHARMA-202102USGW00654" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "23.1", "reactionmeddrapt": "Seizure", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "23.1", "reactionmeddrapt": "Constipation", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "DULCOLAX (BISACODYL)", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "BISACODYL" } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROCORTISONE.", "drugdosagetext": "UNK", "drugdosageform": "CREAM", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "HYDROCORTISONE" }, "openfda": { "application_number": [ "M017", "ANDA088799", "M003", "M007", "ANDA207029", "M006", "M004", "M016", "M", "ANDA214649", "ANDA217160", "ANDA080706", "ANDA217881", "M032", "NDA213876", "ANDA085070", "ANDA040646", "ANDA075172", "ANDA080692", "NDA016199", "NDA218980", "ANDA083231", "ANDA081271", "part348", "M015", "ANDA220329", "ANDA080693", "ANDA087795", "ANDA089414", "ANDA081203", "ANDA203810", "NDA008697", "M005", "ANDA085025", "ANDA085027", "ANDA088250", "ANDA089074" ], "brand_name": [ "HYDROCORTISONE", "DG HEALTH HYDROCORTISONE", "RITE AID ANTI-ITCH", "MEDIBALM", "MEDI-FIRST HYDROCORTISONE 1 % ANTI-ITCH CREAM", "HARRIS TEETER HYDROCORTISONE", "PROCTOSOL-HC", "GOOD NEIGHBOR PHARMACY HYDROCORTISONE", "PUBLIX HYDRO PLUS", "CORTISONE 10 SENSITIVE SKIN CREME", "WALGREENS SCALP RELIEF EXTERNAL ANALGESIC", "SHOPKO HYDROCORTISONE MAXIMUM STRENGTH", "MYMEDIC HYDROCORTISONE", "LEADER HYDROCORTISONE WITH ALOE", "KROGER ANTI ITCH", "HYDROCORTISONE 1%", "TOPCARE HYDROCORTISONE", "ANTI ITCH", "CORTIZONE 10 WATER RESISTANT", "VIADERMA CALM ANTI-ITCH", "POST TREATMENT BALM", "HYDROCORTISONE PLUS 12 MOISTURIZERS", "FIFTHPULSE HYDROCORTISONE 1OZ", "AQUANIL HC", "BARMICIL ANTI-ITCH", "HERB STREET ANTI-ITCH STICK", "THERA PLUS HYDROCORTISONE MAXIMUM STRENGTH", "CORTISONE 10 INTENSIVE MOISTURE CREME", "CORTIZONE 10 SOOTHING ALOE ITCH RELIEF", "EXCHANGE SELECT HYDROCORTISONE", "CARE ONE HYDROCORTISONE MAXIMUM STRENGTH", "REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF", "AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE", "CARING MILLS HYDROCORTISONE", "GELMICIN HYDROCORTISONE WITH ALOE", "GREEN GUARD HYDROCORTISONE 1%", "CAREALL HYDROCORTISONE MAXIMUM STRENGTH", "EQUALINE ANTI ITCH", "BLOOP ITCH SOOTHING TOPICAL", "BERKLEY AND JENSEN ANTI ITCH", "ASTONEA", "SIGNATURE CARE ANTI ITCH", "CORTISONE 10 OVERNIGHT CREME", "CORTIZONE 10 FAST ACTING ITCH RELIEF COOLING", "DRS. 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"2", "medicinalproduct": "LIDOCAINE.", "drugdosagetext": "UNK", "drugdosageform": "JELLY", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "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 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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. 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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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"70000-0366-1", "71399-4456-5", "71399-4456-3", "69968-0614-3", "59088-712-00", "59088-396-84", "71101-011-05", "73581-911-30", "73581-911-15" ], "nui": [ "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": "2", "medicinalproduct": "VITAMINS NOS", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "VITAMINS" } }, { "drugcharacterization": "2", "medicinalproduct": "METROCREAM", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "METRONIDAZOLE" } }, { "drugcharacterization": "2", "medicinalproduct": "METAMUCIL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "PLANTAGO SEED" }, "openfda": { "application_number": [ "M007" ], "brand_name": [ "METAMUCIL THERAPY FOR REGULARITY" ], "generic_name": [ "PSYLLIUM HUSK" ], "manufacturer_name": [ "The Procter & Gamble Manufacturing Company" ], "product_ndc": [ "37000-024", "37000-023" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PSYLLIUM HUSK" ], "rxcui": [ "824586", "880853" ], "spl_id": [ "401e2c29-621f-6e6d-e063-6394a90a8d7d", "44fd342d-94e7-f8ec-e063-6294a90ac87f" ], "spl_set_id": [ "a9824f73-5ea2-4a65-a926-3a57561441b8", "12d030b0-df97-4dd6-88ba-e9fe863c95ea" ], "package_ndc": [ "37000-024-04", "37000-024-10", "37000-023-04", "37000-023-10" ], "unii": [ "0SHO53407G" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20210215" } } } ] }