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 21 of 50 · 997 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Royal Jelly Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
unii: 92RU3N3Y1O
Capsaicin 0.03% PatchCAPSAICIN 0.03%Medcore LLC1046c073-c270-4be3-89f2-e8c91f1af97b2025-11-04WarningsExact identifier
unii: S07O44R1ZM
up and up extra strength gas relief chewables Extra StrengthSIMETHICONETarget Corporation0a015c48-680c-4de1-91e7-1c1145239d8e2025-11-04WarningsExact identifier
unii: 92RU3N3Y1O
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS Medicated Heat 1 ctCAPSAICINCVS Pharmacy, Inc.d41dce5b-e698-4930-8869-040b2a973f252025-10-31WarningsExact identifier
unii: S07O44R1ZM
Coralite Medicated HeatCAPSAICINUnited Exchange Corp.a0b89c7e-80bc-43c4-840c-5fd567f60b212025-10-31WarningsExact identifier
unii: S07O44R1ZM
ADVANCED REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY5faf6229-b0fd-58df-e053-2a91aa0ab3bb2025-10-30WarningsExact identifier
unii: 92RU3N3Y1O
CVS CAPSAICINCAPSAICINCVS PHARMACY9b551fe3-3842-482a-9042-63de5ad398842025-10-30WarningsExact identifier
unii: S07O44R1ZM
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
meijer EXTRA STRENGTH Gas ReliefSIMETHICONEMeijer, Inc3e83bb0f-d909-08c3-e063-6294a90ae1382025-10-29WarningsExact identifier
unii: 92RU3N3Y1O
PUBLIX Extra StrengthSIMETHICONEPUBLIX SUPER MARKETS, INC089d77c9-7aa0-4eee-8363-c47a2d5928cf2025-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength gas reliefSIMETHICONEPUBLIX SUPER MARKETS, INC,029f9254-8cfd-4ea0-8691-2d87df4504332025-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Publix Infants Dye Free Gas ReliefSIMETHICONEPUBLIX SUPER MARKETS, INC2fe74800-a1f6-4774-9976-d6767ba34b492025-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Extra Strength Gas ReliefSIMETHICONEWal-Mart Stores,Inc.,e6087f04-20bf-402c-892b-e64f778b01442025-10-27WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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