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 37 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEATING PAIN RELIEF METHYL SALICYLATE, MENTHOL SUNSET NOVELTIES, INC 498cd2aa-ee59-67b5-e063-6294a90ac242 2026-01-29 Warnings Exact identifier application number: M017 COOLING PAIN RELIEF MENTHOL, CAMPHOR SUNSET NOVELTIES, INC 498d76d8-788b-4cc7-e063-6294a90a1696 2026-01-29 Warnings Exact identifier application number: M017 MQUPIN Lidocaine Gel-Patch LIDOCAINE GEL-PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 49703717-69a6-e480-e063-6394a90ac69c 2026-01-28 Warnings Exact identifier application number: M017 MQXUNMI LIDOCAINE Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 49706db7-bacd-190f-e063-6394a90a3a8e 2026-01-28 Warnings Exact identifier application number: M017 Joint and Muscle Relief Topical Analgesic MENTHOL Smart Cookie Solutions 1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d 2026-01-28 Warnings Exact identifier application number: M017 VonaFlex Effective Pain Relief Topical Analgesic LIDOCAINE HYDROCHLORIDE OPTIMAL LABORATORIES, LLC 0901244a-7d41-413a-b424-92a807532f28 2026-01-28 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Patch LIDOCAINE PAIN RELIEF Dynarex 960e4240-cd09-2560-e053-2a95a90a7bcf 2026-01-28 Warnings Exact identifier application number: M017 ALOE ICE SUNBURN RELIEF LIDOCAINE HYDROCHLORIDE Aloe Care International, LLC 56866fa8-052e-497c-a954-978d7d628949 2026-01-28 Warnings Exact identifier application number: M017 Walgreens Original Strength Anti Itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Walgreen Company a6a49dbb-74c7-47ca-88f2-3bb3d9acf914 2026-01-28 Warnings Exact identifier application number: M017 Flobow QUIT SMOKING Nicotine NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE Jiangxi Yudexi Pharmaceutical Co., LTD 495b10ce-3d2d-1aa4-e063-6294a90a4f35 2026-01-27 Warnings Exact identifier application number: M017 PAIN REUSEABLE PAIN Shenzhen Mengyue Technology Co., Ltd. 44e058fc-e1c0-742b-e063-6294a90ad225 2026-01-27 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Cream Lavender MENTHOL Veridian Healthcare 495eb6e9-69da-f7b6-e063-6294a90accee 2026-01-27 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Cream MENTHOL Veridian Healthcare 49548ab2-267e-1e2a-e063-6394a90ab391 2026-01-27 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL Wal-Mart Stores, Inc. 03feaaef-7401-d464-e063-6294a90a2b2d 2026-01-27 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE STRATEGIC SOURCING SERVICES LLC 4a113699-1eb7-49b8-8cdf-2ad57db89b81 2026-01-27 Warnings Exact identifier application number: M017 Healthy Back Institute Rub On Relief ANALGESIC Fullstack Fulfillment 284c29a3-5722-ce70-e063-6394a90a7fa0 2026-01-26 Warnings Exact identifier application number: M017 Velocx for Joint and Muscle Pain Roll-On Applicator MENTHOL, METHYL SALICYLATE JMAD Consulting LLC, dba JMAD Labs dbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d21 2026-01-26 Warnings Exact identifier application number: M017 CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS CAPSAICIN Meijer Distribution Inc 9b91658f-c15f-4222-bbd9-881b29de3b6e 2026-01-26 Warnings Exact identifier application number: M017 TheraCare Muscle and Joint Gel Vanishing Scent MENTHOL 2.5% Veridian Healthcare 494d2a85-45a8-12a2-e063-6294a90a391b 2026-01-26 Warnings Exact identifier application number: M017 Lidocaine Pain Relief LIDOCAINE Trifecta Pharmaceuticals USA, LLC. 493c09d0-16d7-7413-e063-6394a90aa052 2026-01-26 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