Capsaicin 0.025% Cream

Product NDC
59088-220
11-digit product format
590880220
Labeler code
59088
Product ID
59088-220_28f00df0-c417-f17b-e063-6294a90a5570
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.025%
Dosage form
CREAM
Route
TOPICAL
Labeler
Puretek Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-02
Substance
CAPSICUM OLEORESIN
Active strength
.025 mg/g
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% Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSICUM OLEORESIN.025 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UW86K581WYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28f00df0-c416-f17b-e063-6294a90a5570Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-220-08Capsaicin 0.025% Cream120 g in 1 BOTTLE, PUMPCREAM1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-220-08GM - Gram59088-2206f931949-5174-4cb4-ae81-ac1cd6ce882712025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-220CAPSAICIN 0.025% CREAM (CAPSAICIN 0.025%) CREAM [PURETEK CORPORATION]1Current NDC, 1 package rows20250104_28f00df0-c416-f17b-e063-6294a90a5570.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 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact identifier
application number: M017
Freds Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEFRED'S, INC.7502eebe-11c5-4e9e-b427-b87180a843492025-07-16WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.39688b2b-c1fe-cd86-e063-6394a90a53452025-07-16WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEViolaCare, Inc.8f0ba6e7-8aa4-443e-99ae-a255085ddfec2025-07-15WarningsExact identifier
application number: M017
TopCare Hydrocortisone Intensive Healing FormulaHYDROCORTISONETopco Associates LLC7daafc44-e2a4-4f1b-bfca-3309a8e9a9202025-07-15WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETARGET Corporation72c3889c-b743-4728-a315-6e4063e002002025-07-15WarningsExact identifier
application number: M017
Shopko Hydrocortisone Maximum StrengthHYDROCORTISONEShopko Stores Operating Co., LLC0431a6af-4c9a-4bbd-a535-cba31a5e53cc2025-07-15WarningsExact identifier
application number: M017
Freds Hydrocortisone with AloeHYDROCORTISONEFRED'S, INC.076503bf-8238-4739-bb1c-c385e72f8a962025-07-15WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSN28f00df0-c416-f17b-e063-6294a90a55701
198555capsaicin 0.25 MG/ML Topical CreamSCD28f00df0-c416-f17b-e063-6294a90a55701
198555capsaicin 0.025 % Topical CreamSY28f00df0-c416-f17b-e063-6294a90a55701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-220-0859088022008120 g in 1 BOTTLE, PUMP (59088-220-08) 120 g2025-01-02NoNoCurrent