Capsaicin 0.025%

Product NDC
80425-0541
11-digit product format
804250541
Labeler code
80425
Product ID
80425-0541_3bdcef9c-c018-f973-e063-6394a90a33c5
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.025%
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Advanced Rx of Tennessee, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-08
Substance
CAPSAICIN
Active strength
2.5 mg/10g
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 0.025%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN2.5 mg/10g

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
3bdcef94-d06f-9152-e063-6294a90a6072Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0541-1Capsaicin 0.025%30 in 1 BOXPATCH301
80425-0541-1Capsaicin 0.025%10 g in 1 PATCHPATCH101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0541-1EA - Each80425-05417e26495a-5001-4256-8eaa-ec77a2b81e6d12025-09-12

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 82 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aruba Aloe AlcoholadaLIDOCAINE HYDROCHLORIDEAruba Aloe Balm NVf56c62b0-75db-4499-858e-54e10b0e140a2025-08-07WarningsExact identifier
application number: M017
SurviveX Hydrocortisone CreamHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.3bd1da8d-5142-798c-e063-6294a90a7be62025-08-07WarningsExact identifier
application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGESOOTHING PAIN RELIEF MASSAGEBeijing JUNGE Technology Co., Ltd.3524ad62-0ed6-f2e5-e063-6394a90a32832025-08-06WarningsExact identifier
application number: M017
Alumier MD Intensive RecoveryHYDROCORTISONEAlumier Labsd9b79ea1-6558-543c-e053-2995a90ae53e2025-08-06WarningsExact identifier
application number: M017
Good Neighbor Roll-on Pain ReliefLIDOCAINE HCLAmerisource Bergena0c3adbf-fa35-47c0-9db3-459ce9a106ac2025-08-06WarningsExact identifier
application number: M017
Good Neighbor Roll-on Menthol Pain Relief GelMENTHOLAmerisource Bergenbd557323-0003-4ee6-b22d-a72d621c7de42025-08-05WarningsExact identifier
application number: M017
Earthmed FS Pain relieving balmMENTHOLEarthmed LLC3ba4e769-fec6-52d9-e063-6394a90a65d42025-08-05WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEHF Acquisition Co LLC, DBA HealthFirst3ba6a5ec-fda2-b2a6-e063-6294a90ac9b62025-08-05WarningsExact identifier
application number: M017
Kocowo Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.3b82989d-7cc3-23d3-e063-6294a90ae2a32025-08-03WarningsExact identifier
application number: M017
Menthol pain relief patchesMENTHOLMenthol pain relief patch3b5fd718-3f86-f7a7-e063-6294a90a8c522025-08-02WarningsExact identifier
application number: M017
Graphene Far Infrared Herbal Pain Relief PatchesCORYDALIS RHIZOMEChangsha Maocheng Trading Co., Ltd3b604a3c-fe91-7096-e063-6394a90afe042025-08-02WarningsExact identifier
application number: M017
Active Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3a9f9ca0-3d8a-796a-e063-6394a90a790c2025-08-01WarningsExact identifier
application number: M017
Active Recovery Pain Relief StickCAMPHOR, MENTHOLCharlottes Web, Inc.3aa037c6-6109-b52e-e063-6394a90a215b2025-08-01WarningsExact identifier
application number: M017
PM Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3aa08859-809d-de8c-e063-6394a90a8e252025-08-01WarningsExact identifier
application number: M017
Wish ultra winter iceMENTHOLLJ Pharmab4c5487c-1314-4d63-96df-077e72e7ee952025-08-01WarningsExact identifier
application number: M017
Rugged Fit Pain Relief Roll OnMENTHOL, METHYL SALICYLATESYSTEM4BOOK LLC39d68734-981c-14d7-e063-6294a90a49192025-08-01WarningsExact identifier
application number: M017
ICY FREEZEMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.28fdb049-b297-4358-9447-7d69ba8797022025-08-01WarningsExact identifier
application number: M017
Cortizone 10 CoolingHYDROCORTISONEChattem, Inc.14d9fce2-9f54-4204-83cb-161de8a303f02025-08-01WarningsExact identifier
application number: M017
Bravado Labs NumbingLIDOCAINE HCLProdigy Media Inc8c43f5b5-b911-4a7a-b2d1-56a09c54b0012025-07-30WarningsExact identifier
application number: M017
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3721c984-1993-6265-e063-6394a90af23f2025-07-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN3bdcef94-d06f-9152-e063-6294a90a60721
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD3bdcef94-d06f-9152-e063-6294a90a60721
1043399capsaicin 0.025 % Medicated PatchSY3bdcef94-d06f-9152-e063-6294a90a60721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0541-18042505410130 PATCH in 1 BOX (80425-0541-1) / 10 g in 1 PATCH30 patch2025-08-08NoNoCurrent