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 98 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
application number: M017
Herb AnalgesicHERB ANALGESIC PASTEChangsha Maocheng Trading Co., Ltd29373587-9eff-6ea0-e063-6394a90a23b22025-03-18WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
application number: M017
Auvon 4% Menthol Pain Relief GelMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.2dacd6fe-7d69-bcf0-e063-6294a90a03512025-03-14WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limited1ee49cad-84d4-42cf-aa83-c0da6f1b1b842025-03-14WarningsExact identifier
application number: M017
AY BENDITO THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
application number: M017
Hot/Cold Medicated PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Marcella Health3054e7fd-cab2-7f77-e063-6294a90a498d2025-03-14WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Marcella Health30914c0a-fbda-5674-e063-6294a90aba5b2025-03-14WarningsExact identifier
application number: M017
Peppermint Soothing PatchCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORMHenan Lijitang Medical Technology Co., Ltd.30361dd4-1f3d-ac5e-e063-6294a90a23bc2025-03-13WarningsExact identifier
application number: M017
AVCOO Menthol Pain Relief PatchMENTHOLADP Health Limited3036804b-16c3-0c88-e063-6394a90a30842025-03-13WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Marcella Health303d9462-cbfb-6251-e063-6394a90a70652025-03-13WarningsExact identifier
application number: M017
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsExact identifier
application number: M017
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
application number: M017
TheraCare Pain Relief 4% LidocaineLIDOCAINEVeridian Healthcare2d3fc030-5d53-2acd-e063-6294a90a11ab2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d04799f-946d-ac53-e063-6294a90afeb72025-03-11WarningsExact identifier
application number: M017
Muscle and Joint CareLIDOCAINEVege Labs LLC.301966b5-b535-dc04-e063-6394a90aec172025-03-11WarningsExact identifier
application number: M017
Arctic Blast Pain ReleivingMENTHOL, CAMPHOR (SYNTHETIC)Nutriomo Labs Pte, Ltdd5e7d26d-4f63-4b7b-a173-fe3a794c84592025-03-10WarningsExact identifier
application number: M017
Anti ItchWALGREENWalgreens30014ff0-2519-4031-e063-6394a90ae07b2025-03-10WarningsExact 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