Home NDC 49283-581 COOLING PAIN RELIEF
Product NDC 49283-581
11-digit product format 492830581
Labeler code 49283
Product ID 49283-581_4a156400-7002-d00d-e063-6294a90aa714
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 2026-01-29
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength 6; 3 g/100mL; g/100mL
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 COOLING PAIN RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 6 g/100mL CAMPHOR (SYNTHETIC) 3 g/100mL
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 49283-581-20 COOLING PAIN RELIEF 59 mL in 1 TUBE GEL 59 4
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 109 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 49283-581-20 49283058120 59 mL in 1 TUBE (49283-581-20) 59 ml 2026-01-29 No No Current