Capsaicin 0.035 Percent

Product NDC
50488-1035
11-digit product format
504881035
Labeler code
50488
Product ID
50488-1035_e2a30b7f-bcde-4a77-bcbd-3e965d4f8004
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alexso, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
CAPSAICIN
Active strength
.035 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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 0.035 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.035 g/100g

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
577395Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d0bc1cc-e812-4753-b20c-c0357dd6deb5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1035-1Capsaicin 0.035 Percent120 g in 1 BOTTLECREAM1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1035-1GM - Gram50488-103541964388-d8a5-429d-8c3a-dccbbb9de67212026-04-20

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 99 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact identifier
application number: M017
Thunder Fck Male Genital DesensitizerBENZOCAINEPRODUCT MAX GROUP INC93188a42-0d3c-4159-bdc7-bbc5ec5c67442025-03-06WarningsExact identifier
application number: M017
Body Action Climax Guard DelayBENZOCAINEPRODUCT MAX GROUP INCf88e0b42-974e-4f46-a93b-34b06320770a2025-03-06WarningsExact identifier
application number: M017
XENCARE INFLAMAX NATURAL TOPICAL PAINMENTHOL, CAPSAICINXenex Laboratories Inc.25b9621b-3c16-3cb9-e063-6294a90ab5982025-03-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY1cd37b69-2cfb-130d-e063-6394a90af50b2025-03-06WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Co.c22bba5c-bb6f-494e-987a-f6e36c1b48932025-03-06WarningsExact identifier
application number: M017
Redicare Burn GelREDICARE BURN GELRedicare LLC947ac362-acfb-3508-e053-2a95a90a28732025-03-05WarningsExact identifier
application number: M017
Thera Plus Hydrocortisone Maximum StrengthHYDROCORTISONEFOURSTAR GROUP USA, INC.c2bc8f0c-38ea-4124-bc51-bf22e6751a922025-03-04WarningsExact identifier
application number: M017
Thera Plus Eczema Hydrocortisone Anti ItchHYDROCORTISONEFourstar Group USA, Inc.7c72217b-db9a-4573-9f14-4c11528fa4522025-03-04WarningsExact identifier
application number: M017
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.fb89dca6-c0c0-4092-b3f5-e59c956c3d6c2025-03-04WarningsExact identifier
application number: M017
Peppermint soothing creamCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOLHenan Lijitang Medical Technology Co., Ltd.2f6bc332-3006-710d-e063-6394a90acea52025-03-03WarningsExact identifier
application number: M017
Thera Plus Pain Relief Arthritis and MuscleCAPSAICINFOURSTAR GROUP USA, INC.dcff0a2d-7190-4b0c-abde-ba009b8ef0052025-02-28WarningsExact identifier
application number: M017
GoodSense Anti-ItchDIPHENHYDRAMINE HCL, ZINC ACETATEGeiss, Destin & Dunn, Inc2f38bdfc-6135-1b8a-e063-6294a90a67032025-02-28WarningsExact identifier
application number: M017
Capsaicin 0.05% CreamCAPSAICIN 0.05%Puretek Corporation2cf17a28-711f-77bd-e063-6394a90a70612025-02-28WarningsExact identifier
application number: M017
Lidocaine Pain-Relief PatchesLIDOCAINE PATCHMeijer, Inc2f247929-6bff-1e59-e063-6394a90acdba2025-02-27WarningsExact identifier
application number: M017
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONEEncube Ethicals, Inc.12a1774d-a97e-4787-b6b1-8e8cd40b7b702025-02-26WarningsExact identifier
application number: M017
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
application number: M017
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
application number: M017
Icy Hot Pro No-MessCAMPHOR, MENTHOLChattem, Inc.9e8fedf5-fb59-4531-b288-715f851ee05b2025-02-26WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577395capsaicin 0.035 % Topical CreamPSN6d0bc1cc-e812-4753-b20c-c0357dd6deb52
577395capsaicin 0.35 MG/ML Topical CreamSCD6d0bc1cc-e812-4753-b20c-c0357dd6deb52
577395capsaicin 0.035 % Topical CreamSY6d0bc1cc-e812-4753-b20c-c0357dd6deb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50488-1035-150488103501120 g in 1 BOTTLE (50488-1035-1) 120 g2025-09-01NoNoCurrent