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 39 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Easment advanced absorption cream CAPSAICIN 0.1% Easment LLC 48de3ced-f67f-7c86-e063-6294a90a340c 2026-01-20 Warnings Exact identifier application number: M017 Black Cobra Tattoo NumbingSpray 4% Lidocaine LIDOCAINE Foshan Sugar Max Cosmetics CO.,Ltd 3605fcbf-63c8-87b5-e063-6294a90a9c3e 2026-01-19 Warnings Exact identifier application number: M017 Black Cobra Tattoo Numbing Cream 4% Lidocaine LIDOCAINE Foshan Sugar Max Cosmetics CO.,Ltd 3605961a-d596-9c4a-e063-6394a90a99dc 2026-01-19 Warnings Exact identifier application number: M017 Bakers Best Arthritis Pain Relief HISTAMINE DIHYDROCHLORIDE Baker's Best Health Products, LLC 869735f9-335e-4a5e-adfc-91167ae943c5 2026-01-19 Warnings Exact identifier application number: M017 SIMPLY VITAL PAIN RELIEF HEMP MENTHOL ALPHA PLANTS INC c14f4c06-cfe5-497e-9f9e-b2ba442e61bb 2026-01-19 Warnings Exact identifier application number: M017 AsperFlex MENTHOL AND METHYL SALICYLATE Akron Pharma Inc. 117de175-976d-44f3-85ed-3d127fbe3a7c 2026-01-19 Warnings Exact identifier application number: M017 Equate Pain Relieving Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE Wal-Mart Stores Inc 5ed1d7b3-925e-4a18-8e15-636f5b442ad7 2026-01-19 Warnings Exact identifier application number: M017 Equate Medicated Pain Relieving Patch, Large 6-Count CAMPHOR, MENTHOL, METHYL SALICYLATE Walmart Stores Inc 2c25cd7a-7e7b-5add-e063-6294a90a9e9b 2026-01-19 Warnings Exact identifier application number: M017 Equate Hydrocortione 1% HYDROCORTISONE Walmart Inc. 85b7f620-cc95-4333-b124-bbcc8fd5f7eb 2026-01-19 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL GURUNANDA, LLC 3f1d146e-0d18-7f2f-e063-6394a90ab816 2026-01-19 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine LIDOCAINE Chattem, Inc. 7ad8efa9-7031-4cd0-be1d-6dee63091fd1 2026-01-19 Warnings Exact identifier application number: M017 Best Choice Targeted Warming Capsaicin Heat Patch CAPSAICIN Valu Merchandisers Company 24ca40b7-e17b-42a3-bcc8-6861b9a5934a 2026-01-18 Warnings Exact identifier application number: M017 TOPCARE PAIN RELIEF PATCHES LIDOCAINE TOPCO ASSOCIATES, LLC fa2f7768-e779-4409-aad3-6c33ce2e6b36 2026-01-18 Warnings Exact identifier application number: M017 Neuropathy Pain Relief Cream MENTHOL CREAM Owell Naturals Brand, LLC 48979093-2992-5fd8-e063-6394a90a815d 2026-01-17 Warnings Exact identifier application number: M017 CVS Lidocaine Pain Relief Cream LIDOCAINE HYDROCHLORIDE CVS Pharmacy 45c4f946-13b9-7a0a-e063-6394a90a7353 2026-01-16 Warnings Exact identifier application number: M017 TopCare Pain Relieving Cream LIDOCAINE HCL 4% Topco Associates, LLC 4885a7e6-a127-450a-e063-6294a90a4f91 2026-01-16 Warnings Exact identifier application number: M017 Calmara CALMARA Dynarex Corporation 487393e9-6619-6033-e063-6294a90a68b2 2026-01-16 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT Walgreens 7088092c-3a5f-4fcc-84cc-931d238f7501 2026-01-15 Warnings Exact identifier application number: M017 Itch Relief Gel DIPHENHYDRAMINE HCL Walgreens 487060a7-dff3-4840-b967-ca919f8d0a29 2026-01-15 Warnings Exact identifier application number: M017 Walgreen Itch Relief Gel DIPHENHYDRAMINE HYDROCHLORIDE Walgreens 5aca3297-406f-4165-9895-c58ccffb374f 2026-01-15 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