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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WW64GZ6LQY	Internal UNII lookup
3POA0Q644U	Internal UNII lookup
5TJD82A1ET	Internal UNII lookup
S07O44R1ZM	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
41623a46-e6e7-907e-e063-6394a90afc4c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

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 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3POA0Q644U	HISTAMINE DIHYDROCHLORIDE	56-92-8	HISTAMINE DIHYDROCHLORIDE
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

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