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 85 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shopko HydrocortisoneHYDROCORTISONEShopko Stores Operating Co., LLC92bcbde3-401a-4301-854e-c352852317d62025-07-15WarningsExact identifier
application number: M017
TopCare HydrocortisoneHYDROCORTISONETopco Associates LLCbd3585fa-3b48-49b7-8ad1-749bf1e31ed52025-07-15WarningsExact identifier
application number: M017
Methyl Salicylate 25% Pain RelievingMETHYL SALICYLATEPuretek Corporation376797ff-cf13-a3c6-e063-6394a90a9de12025-07-15WarningsExact identifier
application number: M017
TIGER BALM PAIN RELIEVINGCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.440e97bc-bd97-4733-9955-643b18e7fb182025-07-15WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving Hydrogel LargeCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.064d04ca-184d-492b-867c-beaa165ab3e02025-07-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMedcore LLC143f76bf-2de4-466a-8a6b-d6ab6314a2c32025-07-14WarningsExact identifier
application number: M017
BLUESPRING Doctors Pain Formula Pain ReliefMENTHOLACA MANAGEMENT LLC98f3f719-792f-4a93-95b1-90072e0f8bf42025-07-14WarningsExact identifier
application number: M017
Shopko Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEShopko Stores Operating Co., LLC130119eb-b87e-4a07-8d2a-317369bfa5412025-07-14WarningsExact identifier
application number: M017
Equate Hydrocortisone Intensive Healing FormulaHYDROCORTISONEWal-Mart Stores Inc.635b49c4-54d2-4b6d-bee8-851fc2c7ca9c2025-07-14WarningsExact identifier
application number: M017
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact 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