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 23 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kevo-Prophen	JUNIPER TAR	Faeve, LLC	4fe773a8-77cd-831e-e063-6294a90ae2ca	2026-04-20	Warnings	Exact identifier application number: M017
BeeVenom	METHYL SALICYLATE	Menper Distributors, Inc.	4fe7a986-336d-ad4e-e063-6294a90a0b8a	2026-04-20	Warnings	Exact identifier application number: M017
Benzodent	BENZOCAINE	Focus Consumer Healthcare, LLC	5fdcb871-d387-6352-e053-2991aa0a09da	2026-04-20	Warnings	Exact identifier application number: M017
Tecnu Calagel	DIPHENHYDRAMINE HYDROCHLORIDE	Tec Laboratories Inc.	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	2026-04-20	Warnings	Exact identifier application number: M017
Aemerry Numbing Cream	MENTHOL 5%	Da Capo Prima LLC	4fefddaf-19c8-86b4-e063-6294a90abffc	2026-04-20	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	4 Visions LLC	4fc7a356-2f1d-85af-e063-6394a90aec6b	2026-04-18	Warnings	Exact identifier application number: M017
Equate Lidocaine and Menthol Paraben Free	LIDOCAINE 4% PLUS MENTHOL 1%	Walmart Stores Inc	4fa917de-bc46-0b8d-e063-6294a90a218a	2026-04-17	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Advanced Rx of Tennessee, LLC	4faa515f-6040-d948-e063-6294a90a187f	2026-04-17	Warnings	Exact identifier application number: M017
Coleman Bite and Sting Relief	EXTERNAL ANESTHETIC AND FIRST AID ANTISEPTIC	Wisconsin Pharmacal Company	4fadf1f1-478a-5104-e063-6294a90a10cb	2026-04-17	Warnings	Exact identifier application number: M017
Ice Gel ICE COLD ANALGESIC	MENTHOL	Universal Distribution Center LLC	4f921ced-7722-cba5-e063-6294a90a650b	2026-04-16	Warnings	Exact identifier application number: M017
Walgreens Capsaicin Hot Patch	CAPSAICIN	Walgreen Co.	41e959d8-f6ac-f5b4-e063-6294a90abd96	2026-04-16	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relieving Patch	MENTHOL	Walgreen Co.	41e7574a-348f-8eb8-e063-6294a90a6e90	2026-04-16	Warnings	Exact identifier application number: M017
Coleman Sting and Bite Relief	EXTERNAL ANALGESIC AND FIRST AID ANTISEPTIC	Wisconsin Pharmacal Company	4f94ab35-3099-716c-e063-6294a90a8bea	2026-04-16	Warnings	Exact identifier application number: M017
Kroger Witch Hazel	WITCH HAZEL	Kroger Co.	461407d0-fbf6-47e9-e063-6394a90a9a83	2026-04-16	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	86fe4e8c-5279-445a-a19a-e694eac785fd	2026-04-16	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	4503208f-2808-4727-8066-c431230bd70b	2026-04-16	Warnings	Exact identifier application number: M017
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON	MENTHOL	TROY MANUFACTURING, INC	895896dc-0762-40a7-8313-cca10ce68984	2026-04-16	Warnings	Exact identifier application number: M017
HealthWise Medicated Cold Hot 5%	MENTHOL	Veridian Healthcare	4f9b1b2d-1acc-e0a7-e063-6394a90aadbc	2026-04-16	Warnings	Exact identifier application number: M017
Lidoease 2%	LIDOCAINE HCL 2%	PureTek Corporation	3ba0c0ff-0f7a-7a29-e063-6294a90a547a	2026-04-16	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Pain Relieving Patch Assorted	LIDOCAINE	Walgreen Co.	41e98f15-669f-4543-e063-6294a90a1ef7	2026-04-15	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