Home NDC 78192-500 MENTOL ICE gel
Product NDC 78192-500
11-digit product format 781920500
Labeler code 78192
Product ID 78192-500_5d45c982-eb83-b88c-e063-6394a90ae513
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Camphor
Dosage form GEL
Route TOPICAL
Labeler BOE Dominicana SRL
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-10-07
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength 4; 6 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 MENTOL ICE gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 4 g/100g CAMPHOR (SYNTHETIC) 6 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2600910 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 11 of 147 · 2,937 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78192-500-01 78192050001 240 g in 1 JAR (78192-500-01) 240 g 2026-10-07 No No Current