FDA.reportPublic FDA data

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 14 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Roll Pain AwayCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547e647b-0205-221c-e063-6294a90a757c2026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LemongrassCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef5c0-bc31-d83e-e063-6394a90abfa62026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LavenderCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef2d9-f5c7-9de1-e063-6394a90a218b2026-06-17WarningsExact identifier
application number: M017
Velloryn EXTRA STRENGTH NEUROPATHYVELLORYN EXTRA STRENGTH NEUROPATHYGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f755f-c65c-37ef-e063-6394a90aa2202026-06-17WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsExact identifier
application number: M017
Medi First Extra Strength Itch ReliefDIPHENHYDRAMINE, ZINC ACETATEUnifirst First Aid Corporation54614e5b-8c72-d308-e063-6294a90a405d2026-06-16WarningsExact identifier
application number: M017
Blue Ice AnalgesicMENTHOLDelon Laboratories (1990) Ltd184ed488-6e62-40c6-bb71-1d523280fd6b2026-06-16WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1 % Anti-Itch CreamHYDROCORTISONEUnifirst First Aid Corporation49f04e5d-746d-cbe9-e063-6294a90a7e882026-06-16WarningsExact identifier
application number: M017
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving CoolCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.41590ba1-32bb-4352-97ba-d6a3cc9d05462026-06-15WarningsExact identifier
application number: M017
HIGH POTENCY PAIN RELIEFCAPSAICINXiamen Weisiqi Technology Co., Ltd.543949a4-86ed-3734-e063-6394a90a24f22026-06-14WarningsExact identifier
application number: M017
Natucure HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD49e402ed-d314-e896-e063-6294a90a826b2026-06-14WarningsExact identifier
application number: M017
Nieapf NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e7534f-bccf-4ef4-e063-6294a90aeb7f2026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGHEALMUSZ NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49976ff7-49a4-e4ed-e063-6294a90a3f782026-06-14WarningsExact identifier
application number: M017
HEALMUSZ HEMORRHOID FISSURELIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSUREJiangxi Yudexi Pharmaceutical Co., LTD4a342ac0-6a8d-3408-e063-6394a90a9a102026-06-14WarningsExact identifier
application number: M017
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4cbb7df5-5771-ce4b-e063-6294a90aab802026-06-14WarningsExact identifier
application number: M017
HEALMUSZ ECZEMAHYDROCORTISONE 1% ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD511e54e0-2abe-fb76-e063-6294a90ada682026-06-14WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
application number: M017
Icy Hot Pain Relieving BalmMENTHOL AND METHYL SALICYLATEChattem, Inc.40c8c02f-fa5f-4e80-81a0-48271fa6f94b2026-06-12WarningsExact 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