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 12 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVON Foot Works Arthritis Achy Foot and MuscleMETHYL SALICYLATECOSMAX USA, CORPORATION56440d3f-bc93-cebb-e063-6294a90a5f792026-07-10WarningsExact identifier
application number: M017
CHEONG KUN PAIN RELIEVINGCAMPHORCHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED557d5cb3-2a05-4f45-e063-6394a90a9b122026-07-10WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
application number: M017
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
application number: M017
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
application number: M017
Lidocaine creamDRS LIDOCAINE 5% CREAMOL PHARMA TECH LLC. (Drs. Pharmacy)372fe018-1e5a-9ec4-e063-6294a90a15002026-07-09WarningsExact identifier
application number: M017
Nupharmisto 4% Lidocaine Numbing creamLIDOCAINE 4%EveryMarket Inc5615e49d-e03b-f915-e063-6294a90a17862026-07-08WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
application number: M017
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
application number: M017
Natures Willow Balm Roll On Pain ReliefMENTHOLWB Ventures LLC3b1834e6-75cd-5380-e063-6294a90ad1d52026-07-08WarningsExact identifier
application number: M017
Natures Willow Balm Itch Relief CreamMENTHOLWB Ventures LLC0ce31b5d-4401-460c-e063-6394a90ab5582026-07-08WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.560a4abf-31dd-333f-e063-6294a90a35052026-07-08WarningsExact identifier
application number: M017
Natures Willow BalmMENTHOLWB VENTURES LLCb9f50c43-b0d5-39a8-e053-2995a90a04f12026-07-08WarningsExact identifier
application number: M017
Natures Willow Bug Bite BalmMENTHOLWB Ventures LLCb9fab18f-32c7-d5bd-e053-2995a90a6d0f2026-07-08WarningsExact identifier
application number: M017
Salonpas pain relieving hotCAPSAICIN, MENTHOLHisamitsu Pharmaceutical Co., Inc.d2aa8820-a947-404b-b617-e692fbd165022026-07-07WarningsExact identifier
application number: M017
Quali Yi Tiao Gen Pain PatchCAPSAICIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d2026-07-07WarningsExact identifier
application number: M017
DIPROSPANHYDROCORTISONEOPMX LLC55fa9ecb-b843-5748-e063-6294a90a2d532026-07-06WarningsExact identifier
application number: M017
MUYOHON Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.55caf0a5-f062-a6c3-e063-6294a90ae0732026-07-04WarningsExact identifier
application number: M017
Targeted Warming Capsaicin PatchCAPSAICINArmy & Air Force Exchange Service55b539f8-38c4-594e-e063-6394a90afbaa2026-07-03WarningsExact identifier
application number: M017
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsExact 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