Home NDC 49283-583 MENTHOL, CAMPHOR
Product NDC 49283-583
11-digit product format 492830583
Labeler code 49283
Product ID 49283-583_4c989a37-d55b-edda-e063-6294a90a45ab
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, CAMPHOR
Dosage form GEL
Route TOPICAL
Labeler CHEMCO CORPORATION
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-05
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength 6; 3 g/100g; 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 MENTHOL, CAMPHOR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 6 g/100g CAMPHOR (SYNTHETIC) 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 5TJD82A1ET Internal UNII 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 49283-583-04 MENTHOL, CAMPHOR 113 g in 1 BOTTLE, PUMP GEL 113 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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49283-583-04 49283058304 113 g in 1 BOTTLE, PUMP (49283-583-04) 113 g 2026-03-05 No No Current