Home NDC 82461-421 Capsaicin 0.035
Product NDC 82461-421
11-digit product format 824610421
Labeler code 82461
Product ID 82461-421_1037be37-fbca-4367-b228-e6c744ad8cff
Type HUMAN OTC DRUG
Nonproprietary name Capsaicin
Dosage form PATCH
Route TOPICAL
Labeler Medcore LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-04
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
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 2702859 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82461-421-10 82461042110 10 PATCH in 1 CARTON (82461-421-10) / 100 g in 1 PATCH 10 patch 2026-09-04 No No Current