Home NDC 82461-417 Capsaicin 0.035% cream
Product NDC 82461-417
11-digit product format 824610417
Labeler code 82461
Product ID 82461-417_0371fc78-d964-4a3c-a2c3-7a1f6e8ad18a
Type HUMAN OTC DRUG
Nonproprietary name Capsaicin
Dosage form CREAM
Route TOPICAL
Labeler Medcore LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-04
Substance CAPSAICIN
Active strength .35 mg/mL
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% cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .35 mg/mL
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 82461-417-10 Capsaicin 0.035% cream 100 mL in 1 BOTTLE, PUMP CREAM 100 1
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 97 of 151 · 3,010 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 82461-417-10 82461041710 100 mL in 1 BOTTLE, PUMP (82461-417-10) 100 ml 2026-05-04 No No Current