Home NDC 61577-3440 Sombra Max
Product NDC 61577-3440
11-digit product format 615773440
Labeler code 61577
Product ID 61577-3440_41623a46-e6e8-907e-e063-6394a90afc4c
Type HUMAN OTC DRUG
Nonproprietary name Sombra Max
Dosage form CREAM
Route TOPICAL
Labeler Sombra Cosmetics Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-01
Substance MENTHOL GLUCURONIDE; HISTAMINE DIHYDROCHLORIDE; CAMPHOR (SYNTHETIC); CAPSAICIN; METHYL SALICYLATE
Active strength 6; .025; 3; .025; 12 g/100g; g/100g; g/100g; g/100g; g/100g
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 Sombra Max
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL GLUCURONIDE 6 g/100g HISTAMINE DIHYDROCHLORIDE .025 g/100g CAMPHOR (SYNTHETIC) 3 g/100g CAPSAICIN .025 g/100g METHYL SALICYLATE 12 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
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 61577-3440-1 Sombra Max 1 g in 1 CONTAINER CREAM 1 1 61577-3440-2 Sombra Max 1 g in 1 PACKET CREAM 1 1
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 18 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 61577-3440-1 61577344001 1 g in 1 CONTAINER (61577-3440-1) 1 g 2026-01-01 No No Current 61577-3440-2 61577344002 1 g in 1 PACKET (61577-3440-2) 1 g 2026-01-01 No No Current