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 22 of 50 · 997 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Infants Gas Relief DropsSIMETHICONEWal-Mart Stores,Inc.,966f0506-c2d2-4d3c-bd2d-c5a6b1e0a1572025-10-27WarningsExact identifier
unii: 92RU3N3Y1O
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
unii: 92RU3N3Y1O
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEIMO-GEN LABS LLC41d6dba5-e411-c8d2-e063-6294a90ae8fa2025-10-23WarningsExact identifier
unii: 92RU3N3Y1O
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
unii: S07O44R1ZM
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
unii: 92RU3N3Y1O
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bc1c0c-63d5-0d41-e063-6394a90a341b2025-10-22WarningsExact identifier
unii: S07O44R1ZM
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bd0769-6ba0-d0d5-e063-6294a90af7c92025-10-22WarningsExact identifier
unii: S07O44R1ZM
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
unii: 92RU3N3Y1O
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
unii: 92RU3N3Y1O
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
unii: 92RU3N3Y1O
Coralite Muscle and Joint Pain ReliefCAPSACINUnited Exchange Corp.ba9a3d72-db7a-4dd0-9220-f43c9ed871142025-10-21WarningsExact identifier
unii: S07O44R1ZM
Advanced Healing Diabetic Skin CareDIMETHICONEEco-Logics, Inc.c6704d06-0311-406e-98a7-b8c8881aefd52025-10-18WarningsExact identifier
unii: 92RU3N3Y1O
TrubrexaLIDOCAINE AND CAPSAICINPHOENIX RX LLC3a6500e6-3820-392f-e063-6294a90a769e2025-10-17WarningsExact identifier
unii: S07O44R1ZM
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
unii: S07O44R1ZM
Nufabrx Lower Leg SleeveCAPSAICINNufabrx LLCb8e3e528-b7cd-e4b7-e053-2995a90a40292025-10-15WarningsExact identifier
unii: S07O44R1ZM
Nufabrx Medicine Infused Ankle SleeveCAPSAICINNufabrx LLC013d60c7-a613-7cdf-e063-6294a90ad5842025-10-15WarningsExact identifier
unii: S07O44R1ZM
Nufabrx Calf SleeveCAPSAICINNufabrx LLCbd9459c4-5596-746f-e053-2995a90a54002025-10-15WarningsExact identifier
unii: S07O44R1ZM
Nufabrx Arm SleeveCAPSAICINNufabrx LLCa7993eaf-6488-a818-e053-2995a90a7ea62025-10-15WarningsExact identifier
unii: S07O44R1ZM

Reported adverse events (FAERS/openFDA)#

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