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 11 of 50 · 997 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
unii: 92RU3N3Y1O
gas reliefSIMETHICONEBIONPHARMA INC.4d7a9507-6f3c-6d15-e063-6294a90a01602026-03-20WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
unii: 92RU3N3Y1O
CapsaicinCAPSAICINAlexso, Inc030d67b2-d798-4134-bc96-69536ad46f2d2026-03-19WarningsExact identifier
unii: S07O44R1ZM
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc597e0d44-21f8-4f98-b932-70345462f3592026-03-19WarningsExact identifier
unii: S07O44R1ZM
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
unii: 92RU3N3Y1O
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
unii: S07O44R1ZM
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.42477582-3ffa-4e51-a29b-86da07b143822026-03-17WarningsExact identifier
unii: 92RU3N3Y1O
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDAILY MOISTRUIZINGWalgreen Co.27452cc7-1ec6-4571-bcd0-0a7103735ee52026-03-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
unii: 92RU3N3Y1O
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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