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 42 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortizone 10 Intensive Healing for Eczema HYDROCORTISONE Chattem, Inc. 31dc0f1f-ddd8-41dc-b669-b24655634d55 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Overnight Creme HYDROCORTISONE Chattem, Inc. ef2eda7e-d6a8-47e3-9d80-6074af6773dc 2026-01-14 Warnings Exact identifier application number: M017 CVS Pain Relief Lavender Scent MENTHOL 4% CVS 484b0833-9f8a-f155-e063-6294a90a1869 2026-01-13 Warnings Exact identifier application number: M017 EARTHS CARE ANTI-ITCH CAMPHOR (NATURAL), MENTHOL DLC Laboratories, Inc. d1eabb5f-7086-4ff0-a398-3703c9ecd441 2026-01-13 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Menthol Pain Relief MENTHOL Veridian Healthcare 25e3d9cd-6ba3-4e06-8853-324b9d669248 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 1ac2ed54-194c-4de2-8e7f-6e74ca32aa40 2026-01-13 Warnings Exact identifier application number: M017 Pain Release Joint and Arthritis Cream MENTHOL Saje Natural Business Inc. 18b24d75-17f7-1a35-e063-6394a90a55e0 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. a32b0950-3467-4e37-988d-104836af5971 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 92eec6e7-0367-43c6-bd28-1762390a7114 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 481a493b-0620-46ac-8228-e9964b7eb24b 2026-01-13 Warnings Exact identifier application number: M017 Restoral MENTHOL Saje Natural Business Inc. 5b6176c1-9ed9-1950-e053-2a91aa0a434e 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Lidocaine with Eucalyptus Essential Oil LIDOCAINE HCL Chattem, Inc. 03e247b4-a2e2-4354-a018-880f1bc987fd 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Lidocaine Foot (Diabetic) LIDOCAINE HYDROCHLORIDE Chattem, Inc. 2c33d15e-5032-46d9-bd98-5abc7df3bbe5 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Essential Oils Rosemary Mint LIDOCAINE Chattem, Inc. 9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab 2026-01-13 Warnings Exact identifier application number: M017 Capzasin HP Arthritis Pain Relief CAPSAICIN Chattem, Inc. 345c9159-0efe-436b-9068-3b717678936b 2026-01-13 Warnings Exact identifier application number: M017 Capzasin Quick Relief CAPSAICIN AND MENTHOL Chattem, Inc. d6c313a3-8dc6-4231-95b6-ac9399e1c1be 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Pain Relieving TROLAMINE SALICYLATE Chattem, Inc. 97dd587b-ecc3-4b4b-a116-6355d3c6ea6d 2026-01-13 Warnings Exact identifier application number: M017 Dr Wellskin Numbing Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 482f25cc-dee3-c3b6-e063-6294a90a8674 2026-01-12 Warnings Exact identifier application number: M017 BLT 2 LIDOCAINE HCL CENTURA PHARMACEUTICALS INC 41dc85ec-d79b-0a32-e054-00144ff8d46c 2026-01-12 Warnings Exact identifier application number: M017 Mineral Ice Pain Relieving MENTHOL Crown Laboratories 7b30076a-0af6-2f74-e053-2a91aa0ae08d 2026-01-12 Warnings Exact identifier application number: M017
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