Home NDC 76420-947 EXOTEN-C
Product NDC 76420-947
11-digit product format 764200947
Labeler code 76420
Product ID 76420-947_07cec02c-17d3-145d-e063-6294a90a0fb3
Type HUMAN OTC DRUG
Nonproprietary name METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form LOTION
Route TOPICAL
Labeler Asclemed USA, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-02-10
Substance METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength 20; 10; .025 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
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 EXOTEN-C
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 20 g/100g MENTHOL 10 g/100g CAPSAICIN .025 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup L7T10EIP3A Internal UNII lookup 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 1870112 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 76420-947-01 EXOTEN-C 113.4 g in 1 BOTTLE LOTION 113.4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-947 EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [ASCLEMED USA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20231016_76ed37e0-64b5-4abe-a03c-3dc7084a3919.zip
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 18 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 Marketing end Sample Exclude flag Status 76420-947-01 76420094701 113.4 g in 1 BOTTLE (76420-947-01) 113.4 g 2017-02-10 0000-00-00 No No Current