FDA.reportPublic FDA data

Capsaicin

Product NDC
79643-002
11-digit product format
796430002
Labeler code
79643
Product ID
79643-002_407e05ef-30e0-4b17-e063-6394a90aac67
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
PHARMACURE LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-02
Substance
CAPSAICIN
Active strength
.025 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Capsaicin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043399Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
05a09ee5-e7a4-4758-8b16-f60b945a7d82Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-2005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-03-2005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-3005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-3005a09ee5-e7a4-4758-8b16-f60b945a7d82

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-002-01Capsaicin100 g in 1 PATCHPATCH1005
79643-002-01Capsaicin10 in 1 BOXPATCH105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-002-01EA - Each79643-0029cc62b9f-8597-493c-ae49-9c5caff85cf412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-002CAPSAICIN PATCH [PHARMACURE LLC]4Current NDC, Legacy NDC, 2 package rows20241220_05a09ee5-e7a4-4758-8b16-f60b945a7d82.zip

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 10 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017
Gaayou NumbingDIBUCAINE HYDROCHLORIDE 0.5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4c290118-7880-2a98-e063-6294a90a4c032026-07-21WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a36edc5-5a89-afb5-e063-6294a90a02dd2026-07-21WarningsExact identifier
application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINLIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINJiangxi Yudexi Pharmaceutical Co., LTD4a45c1cb-c5ab-d872-e063-6394a90aab5d2026-07-21WarningsExact identifier
application number: M017
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
application number: M017
DERMFREE MEDICATED LIPCAMPHOR 2.0% MEDICATED LIPJiangxi Yudexi Pharmaceutical Co., LTD4a4d62fb-8dfa-404a-e063-6294a90a385d2026-07-21WarningsExact identifier
application number: M017
NATUHEAL RELIEF Cream FOR ECZEMAHYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD4c92fed1-a8b4-bda8-e063-6394a90a8a332026-07-20WarningsExact identifier
application number: M017
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
application number: M017
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
application number: M017
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
application number: M017
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
application number: M017
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M017
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN05a09ee5-e7a4-4758-8b16-f60b945a7d825
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD05a09ee5-e7a4-4758-8b16-f60b945a7d825
1043399capsaicin 0.025 % Medicated PatchSY05a09ee5-e7a4-4758-8b16-f60b945a7d825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79643-002-017964300020110 PATCH in 1 BOX (79643-002-01) / 100 g in 1 PATCH10 patch2021-02-020000-00-00NoNoCurrent