SOMBRA WARM THERAPY

Product NDC: 61577-3100
11-digit product format: 615773100
Labeler code: 61577
Product ID: 61577-3100_503818c4-aafa-b69c-e063-6294a90a034e
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL CAMPHOR
Dosage form: GEL
Route: TOPICAL
Labeler: SOMBRA COSMETICS INC.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-10
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
Active strength: .03; .03 g/g; g/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 WARM THERAPY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	.03 g/g
CAMPHOR (SYNTHETIC)	.03 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
5TJD82A1ET	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
de78dba9-53b3-4dbd-9dd2-6a692378da34	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-3100-1	SOMBRA WARM THERAPY	226.7 g in 1 JUG	GEL	226.7		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
CAPSICUM	INACTIVE INGREDIENT	00UK7646FG	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
FILIPENDULA ULMARIA FLOWER	INACTIVE INGREDIENT	06L18L32G6	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
GRAPEFRUIT SEED OIL	INACTIVE INGREDIENT	598D944HOL	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
ORANGE PEEL	INACTIVE INGREDIENT	TI9T76XD44	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
SODIUM HYDROXYMETHYLGLYCINATE	INACTIVE INGREDIENT	DIG6BWZ9XT	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4
YUCCA SCHIDIGERA ROOT	INACTIVE INGREDIENT	E2H9ET15AT	SOMBRA WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	4

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 83 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SYNC PRO	SYNC RELIEF PRO CREAM	iON Pharma, LLC	3a3e91d6-732b-dca9-e063-6394a90a06d4	2025-07-28	Warnings	Exact identifier application number: M017
Careland Pain Relief	METHYL SALICYLATE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	83f36771-1033-4fd0-a0e6-82c1dcfedeee	2025-07-28	Warnings	Exact identifier application number: M017
Rite Aid anti-itch	HYDROCORTISONE	Rite Aid Corporation	2a232dd1-9071-4c55-a7f7-19d8404b99a6	2025-07-28	Warnings	Exact identifier application number: M017
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	RITE AID CORPORATION	05598255-3e7a-46a5-ae7e-dcfcb616d59d	2025-07-28	Warnings	Exact identifier application number: M017
Inked Inspired	LIDOCAINE HCL	Prodigy Media Inc	54fb2860-7e63-4598-953a-170226e613e9	2025-07-28	Warnings	Exact identifier application number: M017
Ujhay Hydrocortisone Ointment.	UJHAY HYDROCORTISONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	3af59276-8e6a-0603-e063-6394a90a1f9b	2025-07-27	Warnings	Exact identifier application number: M017
SANA SANA Menthol External Analgesic	MENTHOL	Alquimia Najulam S de RL de CV	8b7edd51-e08a-4e01-9df0-8305ce17b418	2025-07-25	Warnings	Exact identifier application number: M017
Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	TARGET Corporation	682b737f-e453-4079-bf31-47a9485c7897	2025-07-25	Warnings	Exact identifier application number: M017
Chigg Away	BENZOCAINE	Pierson Laboratories, Inc.	8372e7c1-f145-4bc5-85ab-cf831abe70ce	2025-07-24	Warnings	Exact identifier application number: M017
Chigg Away	BENZOCAINE	Pharma Nobis, LLC	e42fa1c6-d804-630f-e053-2995a90add6b	2025-07-24	Warnings	Exact identifier application number: M017
Cannarelief 2000mg	MENTHOL	Earthmed LLC	01f810de-52ba-8beb-e063-6394a90a61c0	2025-07-24	Warnings	Exact identifier application number: M017
CHING WAN HUNG SOOTHING HERBAL BALM	MENTHOL	TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD.	ffadc904-8e9d-4cb8-815a-d583bbdb3f0b	2025-07-24	Warnings	Exact identifier application number: M017
PT Elite Premium Pain Relief	CAPSAICIN, MENTHOL	PT ELITE PRODUCTS LLC	ad251821-4c58-425d-bdcb-8dd9bd41b713	2025-07-23	Warnings	Exact identifier application number: M017
Whipped Butter SPF 50	ZINC OXIDE	Bloomeffects, Inc	374b62d8-e012-591f-e063-6294a90aef93	2025-07-23	Warnings	Exact identifier application number: M017
Game On Xtreme	MENTHOL, UNSPECIFIED FORM	Natural Essentials Inc.	5a1b6192-d537-42b3-add8-22c63e7c986c	2025-07-23	Warnings	Exact identifier application number: M017
AMRUTANJAN RELIEF PAIN BALM	CAMPHOR , MENTHOL, METHYL SALICYLATE	AMRUTANJAN HEALTH CARE LIMITED	ddee6714-8b18-4d87-944b-8467fda22e6b	2025-07-23	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	8bb89002-d7a2-4bee-b5a5-1fd1949273ef	2025-07-22	Warnings	Exact identifier application number: M017
Hielo Ardiente	MENTHOL	Menper Distributors, Inc.	97ec516c-d2bc-47ce-82fe-bd68445d9570	2025-07-22	Warnings	Exact identifier application number: M017
La Flecha Japonesa	METHYL SALICYLATE	Menper Distributors, Inc.	08819ad0-97c2-49bd-b923-535b94a27167	2025-07-22	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Menper Distributors Inc.	ad940dc8-9403-44cf-aed3-6e538cbe488b	2025-07-22	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61577-3100-1	61577310001	226.7 g in 1 JUG (61577-3100-1)	226.7 g	2026-04-10	No	No	Current