FDA.reportPublic FDA data

NDC 10144-920 - Qutenza

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
10144-920
Package NDCs from labels
10144-920-00
Manufacturer
Acorda Therapeutics, Inc. | Sharp Corporation | Contract Pharmaceuticals Limited Canada - Lab Svcs (CPL) | SGS Life Science Services | Exova Canada Inc. | Contract Pharmaceuticals Limited Canada (CPL) | SGS Institut Fresenius GmbH | Lohmann Therapie-Systeme AG (LTS) (Germany)
Effective date
2018-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
QutenzaAcorda Therapeutics, Inc. | Sharp Corporation | Contract Pharmaceuticals Limited Canada - Lab Svcs (CPL) | SGS Life Science Services | Exova Canada Inc. | Contract Pharmaceuticals Limited Canada (CPL) | SGS Institut Fresenius GmbH | Lohmann Therapie-Systeme AG (LTS) (Germany)2018-11-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
capsaicinACTIVE INGREDIENTS07O44R1ZMQUTENZA (CAPSAICIN) KIT [ACORDA THERAPEUTICS, INC.]1
capsaicinACTIVE MOIETYS07O44R1ZMQUTENZA (CAPSAICIN) KIT [ACORDA THERAPEUTICS, INC.]1
diethylene glycol monoethyl etherINACTIVE INGREDIENTA1A1I8X02BQUTENZA (CAPSAICIN) KIT [ACORDA THERAPEUTICS, INC.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OQUTENZA (CAPSAICIN) KIT [ACORDA THERAPEUTICS, INC.]1
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BQUTENZA (CAPSAICIN) KIT [ACORDA THERAPEUTICS, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 50 · 997 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
unii: 92RU3N3Y1O
EXTRA STRENGTH gas reliefSIMETHICONEKRAMER LABORATORIESd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb2025-12-19WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONE 80MGSIMETHICONECardinal Health 107, LLC5e755184-0821-4f92-8f72-84726f7aa4072025-12-18WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TrubrexaLIDOCAINE AND CAPSAICINStrand Health Group074b53d0-d9d8-8d24-e063-6294a90a9fda2025-12-18WarningsExact identifier
unii: S07O44R1ZM
Meijer Berry Lime Antacid HBG ChewsCALCIUM CARBONATEMeijer16efa685-5b74-2661-e063-6394a90ac5062025-12-18WarningsExact identifier
unii: 92RU3N3Y1O
Meijer Max Gas 30ctSIMETHICONEMeijer23f95dcf-3d4c-a119-e063-6394a90a51552025-12-18WarningsExact identifier
unii: 92RU3N3Y1O
ZestamaCAPSAICINV2 Pharma LLCc9b46759-b8df-4ff4-815e-8e032c2635c02025-12-15WarningsExact identifier
unii: S07O44R1ZM
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact identifier
unii: 92RU3N3Y1O
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
unii: S07O44R1ZM
HealthWise Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare7ba0ac53-c78c-4a70-a977-a082f731919e2025-12-15WarningsExact identifier
unii: 92RU3N3Y1O
ULTRA STRENGTH Gas Relief SoftgelsSIMETHICONETopco Associates LLC42c449cc-a450-1796-e063-6294a90a762a2025-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBionpharma Inc.9b0a802f-6fae-4142-ad2f-4b16ed67400e2025-12-12WarningsExact identifier
unii: 92RU3N3Y1O
Toast Screamin HotCAPSAICINIDEAZ, LLC331207e6-b8ac-b169-e063-6394a90ac1692025-12-12WarningsExact identifier
unii: S07O44R1ZM
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6701200-eb58-30f1-e053-2a95a90a032e2025-12-10WarningsExact identifier
unii: 92RU3N3Y1O
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
unii: S07O44R1ZM
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
unii: S07O44R1ZM
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
unii: S07O44R1ZM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.