Home NDC 61577-3100 SOMBRA WARM THERAPY
Product NDC 61577-3100
11-digit product format 615773100
Labeler code 61577
Product ID 61577-3100_503818c4-aafa-b69c-e063-6294a90a034e
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL CAMPHOR
Dosage form GEL
Route TOPICAL
Labeler SOMBRA COSMETICS INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-10
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength .03; .03 g/g; 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 WARM THERAPY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .03 g/g CAMPHOR (SYNTHETIC) .03 g/g
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 61577-3100-1 SOMBRA WARM THERAPY 226.7 g in 1 JUG GEL 226.7 16
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 73 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61577-3100-1 61577310001 226.7 g in 1 JUG (61577-3100-1) 226.7 g 2026-04-10 No No Current