Home NDC 72744-433 COOL BREEZE Pain Relief
Product NDC 72744-433
11-digit product format 727440433
Labeler code 72744
Product ID 72744-433_09135640-d8a9-790c-e063-6294a90a8fce
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler COOL BREEZE US LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-13
Substance MENTHOL
Active strength 51 mg/mL
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 COOL BREEZE Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 51 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2669723 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 72744-433-00 COOL BREEZE Pain Relief 118 mL in 1 TUBE GEL 118 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72744-433 COOL BREEZE PAIN RELIEF (MENTHOL) GEL [COOL BREEZE US LLC] 1 Current NDC, 1 package rows 20231114_14dcf4ee-6778-49d4-8601-9205737432ea.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 48 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 Sample Exclude flag Status 72744-433-00 72744043300 118 mL in 1 TUBE (72744-433-00) 118 ml 2023-11-13 No No Current