Home NDC 61577-3103 SOMBRA COOL THERAPY
Product NDC 61577-3103
11-digit product format 615773103
Labeler code 61577
Product ID 61577-3103_4ffb85fd-c60e-3f70-e063-6294a90a6fdc
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler SOMBRA COSMETICS INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-21
Substance MENTHOL
Active strength .06 g/g
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 SOMBRA COOL THERAPY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .06 g/g
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 415976 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61577-3103-1 SOMBRA COOL THERAPY 85.05 g in 1 TUBE GEL 85.05 12
DailyMed Socrata Ingredients# 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 61577-3103-1 61577310301 85.05 g in 1 TUBE (61577-3103-1) 85.05 g 2026-04-21 No No Current