FDA.reportPublic FDA data

capsaicin 0.08 MG/MG Medicated Patch [Qutenza]

RxCUI
1039681
RxNorm name
capsaicin 0.08 MG/MG Medicated Patch [Qutenza]
Display name
QUTENZA (Topical)
Full name
capsaicin 0.08 MG/MG Medicated Patch [Qutenza]
Term type
SBD
Status
Active
Strength
8%
Dose form
Medicated Patch
Route
Topical
Updated
2026-10-24 12:25:57

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
capsaicin0.08 MG / 1 MGcapsaicincapsaicin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Medicated Patch1792831

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
capsaicin1992

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRQutenza 8 % Medicated Patch1NAMES
RxNorm Namecapsaicin 0.08 MG/MG Medicated Patch [Qutenza]1NAMES
RxNorm SynonymQutenza 8 % Medicated Patch1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID3ffbbcb0-ad93-4f15-bb38-5da76a71c7351CODES
RxCUI10396811CODES
MMSL_CODEBD258361CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
72512-928-0172512-928Qutenza capsaicinAveritas Pharma IncNDA022395
72512-929-0172512-929Qutenza capsaicinAveritas Pharma IncNDA022395
72512-930-0172512-930Qutenza capsaicinAveritas Pharma IncNDA022395

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02239572512-928Qutenza capsaicinNDAAveritas Pharma Inc

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 14 matching rows.

NDC11, Source, Active table
NDC11SourceActive
72512092000rxnav_ndcsyes
72512092801rxnav_ndcsyes
72512092901rxnav_ndcsyes
72512093001rxnav_ndcsyes
10144092000rxnav_historical
10144092801rxnav_historical
10144092901rxnav_historical
49685092000rxnav_historical
49685092001rxnav_historical
49685092002rxnav_historical
49685092801rxnav_historical
49685092802rxnav_historical
72512092001rxnav_historical
72512092002rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QutenzaCAPSAICINAveritas Pharma Inc3ffbbcb0-ad93-4f15-bb38-5da76a71c7352026-07-07Warnings, Adverse reactionsExact identifier
ndc (package): 72512-929-01
ndc (package): 72512-930-01
ndc (package): 72512-928-01
ndc (product): 72512-929
ndc (product): 72512-928
ndc (product): 72512-930
ndc11 (package): 72512092901
ndc11 (package): 72512092801
ndc11 (package): 72512093001
rxcui: 1039681

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3ffbbcb0-ad93-4f15-bb38-5da76a71c735Qutenza 8 % Medicated Patch [PSN] · capsaicin 0.08 MG/MG Medicated Patch [Qutenza] [SBD] · Qutenza 8 % Medicated Patch [SY]313These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA. QUTENZA ® (capsaicin) topical system Initial U.S. Approval: 200920260309

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3ffbbcb0-ad93-4f15-bb38-5da76a71c735These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA. QUTENZA ® (capsaicin) topical system Initial U.S. Approval: 2009Averitas Pharma Inc | Sharp Corporation | Contract Pharmaceuticals Limited Canada | Piramal Healthcare (Canada) Limited | SGS Institut Fresenius GmbH | LTS Lohmann Therapie-Systeme AG | Formosa Laboratories, Inc. | SGS North America, Inc. | FARMACEUTICI FORMENTI SPA | Sharp Clinical Services, LLC20260707
3ffbbcb0-ad93-4f15-bb38-5da76a71c735These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA. QUTENZA ® (capsaicin) topical system Initial U.S. Approval: 2009Averitas Pharma Inc | Sharp Corporation | Contract Pharmaceuticals Limited Canada | Piramal Healthcare (Canada) Limited | SGS Institut Fresenius GmbH | LTS Lohmann Therapie-Systeme AG | Formosa Laboratories, Inc. | SGS North America, Inc. | FARMACEUTICI FORMENTI SPA | Sharp Clinical Services, LLC20260309
3ffbbcb0-ad93-4f15-bb38-5da76a71c735These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA. QUTENZA ® (capsaicin) topical system Initial U.S. Approval: 2009Averitas Pharma Inc | Sharp Corporation | Contract Pharmaceuticals Limited Canada | Piramal Healthcare (Canada) Limited | SGS Institut Fresenius GmbH | LTS Lohmann Therapie-Systeme AG | Formosa Laboratories, Inc. | SGS North America, Inc. | FARMACEUTICI FORMENTI SPA20260212
ab5a8fa3-2eb2-44fd-bf9b-a1ac114e0c9bThese highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA. QUTENZA ® (capsaicin) 8% patch Initial U.S. Approval: 2009Acorda 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)20181105
670fce15-c37a-48b4-a7e4-431cc8fc608dNational Council for Prescription Drug Programs20120724
98b4a145-26b7-4cb1-b808-35ccb993cfddNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCM02ABCapsaicin and similar agentsATC1-4capsaicin
ATCN01BXOther local anestheticsATC1-4capsaicin
MEDRTD002211CapsaicinCHEMhas_ingredientcapsaicin
MEDRTD003929Diabetic NeuropathiesDISEASEmay_treatcapsaicin
MEDRTD004342Drug HypersensitivityDISEASEci_withcapsaicin
MEDRTD006562Herpes ZosterDISEASEmay_treatcapsaicin
MEDRTD009437NeuralgiaDISEASEmay_treatcapsaicin
MEDRTD010146PainDISEASEmay_preventcapsaicin
MEDRTN0000000105Neurotransmitter Transporter InteractionsMOAhas_moacapsaicin
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pecapsaicin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.08 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA022395
NAMESPrescribable SynonymQutenza 8 % Medicated Patch
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon