Home NDC 50488-1035 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 Ingredient Strength CAPSAICIN .035 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S07O44R1ZM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577395 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50488-1035-1 Capsaicin 0.035 Percent 120 g in 1 BOTTLE CREAM 120 2
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 110 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50488-1035-1 50488103501 120 g in 1 BOTTLE (50488-1035-1) 120 g 2025-09-01 No No Current