FDA.reportPublic FDA data

Capsaicin 0.025%

Product NDC
85096-401
11-digit product format
850960401
Labeler code
85096
Product ID
85096-401_3054e998-3591-1481-e063-6394a90a4a48
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.025%
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Marcella Health
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-14
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
3054e7fd-cab2-7f77-e063-6294a90a498dAvailable 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
85096-401-01Capsaicin 0.025%10 g in 1 PATCHPATCH101
85096-401-30Capsaicin 0.025%30 in 1 BOXPATCH301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85096-401-01EA - Each85096-4014a078f5b-aa38-43c6-bd35-d0ef0a46469312025-08-11
85096-401-30EA - Each85096-401cf4db2d7-26ab-4754-b38c-421eea0f21a512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85096-401CAPSAICIN 0.025% PATCH [MARCELLA HEALTH]1Current NDC, 2 package rows20250316_3054e7fd-cab2-7f77-e063-6294a90a498d.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 90 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PLANTAR FASCIITIS Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd37570149-dae1-a4f2-e063-6294a90a32452025-06-11WarningsExact identifier
application number: M017
Diabecin CS CreamMENTHOL, CAPSAICINPuretek Corporation33ef2233-7a66-ee65-e063-6294a90ac55a2025-06-10WarningsExact identifier
application number: M017
KINKAN COOLDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLKINKANDO CO., LTD .82011efe-825c-4102-b6f1-59eff4c8040a2025-06-10WarningsExact identifier
application number: M017
MQUPIN Knee PatchKNEE PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.37438a70-dab7-ecb5-e063-6394a90afefb2025-06-10WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5% Roll OnMENTHOLLiquidCapsule Manufacturing LLC99424327-67e9-43b5-a117-94c9643413c12025-06-07WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLEbanel Laboratories, Inc36edbc3f-501c-c1ea-e063-6394a90af6af2025-06-06WarningsExact identifier
application number: M017
FREEZE IT Menthol Roll OnMENTHOLLiquidCapsule Manufacturing LLC33094afe-db9d-4b92-8047-6dd611484fc92025-06-05WarningsExact identifier
application number: M017
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
application number: M017
FREEZE IT MentholMENTHOLLiquidCapsule Manufacturing LLCde8d8007-5718-4fb4-a8c6-4650d2ca9c8f2025-06-05WarningsExact identifier
application number: M017
HEEL PAIN Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36bacb5f-c1af-2e97-e063-6394a90afe5c2025-06-04WarningsExact identifier
application number: M017
Capsaicin 0.075% CreamCAPSAICINViolaCare, Inc.30911225-a6d7-4b2b-9005-b733373e28772025-06-04WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
application number: M017
HealthWise Lidocaine and MentholLIDOCAINE AND MENTHOLVeridian Healthcare36c27642-f913-1aad-e063-6294a90a43432025-06-04WarningsExact identifier
application number: M017
HealthWise Ultra OTC Strength Pain Relief CreamCAMPHOR, MENTHOL, AND METHYL SALICYLATEVeridian Healthcare36c3bbf9-a559-4c0d-e063-6394a90a8a1a2025-06-04WarningsExact identifier
application number: M017
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
application number: M017
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
application number: M017
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJ&A Digital Inc.d4b09055-b93e-466f-9e24-cae098af6e242025-06-02WarningsExact identifier
application number: M017
RE-LEVEMENTHOLSOMBRA COSMETICS INC.b4b39d79-0439-41e7-adca-e5ccb8f44e402025-05-29WarningsExact identifier
application number: M017
PAIN NO MORE THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.f7bacc8e-6a8b-4cd8-bd0e-68890bee58182025-05-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN3054e7fd-cab2-7f77-e063-6294a90a498d1
1043399capsaicin 0.025 % Medicated PatchPSN3bdcef94-d06f-9152-e063-6294a90a60721
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD3054e7fd-cab2-7f77-e063-6294a90a498d1
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD3bdcef94-d06f-9152-e063-6294a90a60721
1043399capsaicin 0.025 % Medicated PatchSY3054e7fd-cab2-7f77-e063-6294a90a498d1
1043399capsaicin 0.025 % Medicated PatchSY3bdcef94-d06f-9152-e063-6294a90a60721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85096-401-018509604010110 g in 1 PATCH10 gHistorical
85096-401-308509604013030 PATCH in 1 BOX (85096-401-30) / 10 g in 1 PATCH (85096-401-01) 30 patch2025-03-14NoNoCurrent