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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr.Harry COMFORT ZONE Cream	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4d32b89f-72e8-bc93-e063-6394a90a0bc8	2026-03-17	Warnings	Exact identifier application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain Relief	CAPSAICIN, MENTHOL	Milo Rod Import & Export, Inc.	c3622dc3-0c05-47c9-b70b-498946781906	2026-03-17	Warnings	Exact identifier application number: M017
Walgreens Burn Pad	BURN PAD	Walgreens	3f8d7624-cf1e-1992-e063-6294a90a3806	2026-03-17	Boxed warning, Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Mericon Industries	8f351b04-8f6d-4353-9100-13a8a80d656a	2026-03-17	Warnings	Exact identifier application number: M017
Shoe Pain Relief	LIDOCAINE HCI 4%	Sole Amie	0f2ccd5f-b9f4-40fc-b82f-173b0f19bf40	2026-03-16	Warnings	Exact identifier application number: M017
CVS Muscle Balm	MENTHOL, CAMPHOR	CVS Health	42796fc4-03be-3b02-e063-6394a90af2ab	2026-03-16	Warnings	Exact identifier application number: M017
Crane Safety Hydrocortisone	HYDROCORTISONE	Crane Safety LLC	96d9527d-9bf7-ce82-e053-2995a90aff0c	2026-03-16	Warnings	Exact identifier application number: M017
CVS Health Pain Relief Foot	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	0f646876-69d0-49db-ade2-2b3eb26dd399	2026-03-16	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relief Foot Cream	MENTHOL	Walgreen Co.	3bc8ece3-d555-3efb-e063-6394a90a1981	2026-03-16	Warnings	Exact identifier application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOT	MENTHOL	RICHTOFIT LIMITED LIABILITY COMPANY	4c357696-ca96-e6ad-e063-6294a90aaadb	2026-03-16	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	348e6062-b31e-435e-a153-6aa868b50efa	2026-03-13	Warnings	Exact identifier application number: M017
DGH GREASELESS MUSCLE RUB ANALGESIC	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	DOLLAR GENERAL	225abfe0-ec72-4667-96b2-7657e989672b	2026-03-13	Warnings	Exact identifier application number: M017
CVS Professional Pain Relief	MENTHOL	CVS Pharmacy	48836a5b-0baa-b7ee-e063-6294a90ac12b	2026-03-13	Warnings	Exact identifier application number: M017
Keeps Climax Delay	LIDOCAINE HYDROCHLORIDE	Cosco International, Inc.	3bfd3173-2dac-40a9-aec3-982b1d47d8fa	2026-03-12	Warnings	Exact identifier application number: M017
NanoX Pain Relieving	MENTHOL, METHYL SALICYLATE	MG Science Technologies LLC	4cc38927-8a8c-2df3-e063-6294a90aa0c1	2026-03-12	Warnings	Exact identifier application number: M017
Hand Sanitizer	ALCOHOL	ProStat First Aid	4cd4c51c-88bb-3797-e063-6294a90a8f70	2026-03-12	Warnings	Exact identifier application number: M017
CVS Lidocaine Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	CVS Pharmacy	48c045ae-56b5-62c2-e063-6394a90aaf44	2026-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	ProStat First Aid	4cd62cba-075a-7448-e063-6394a90ab48d	2026-03-12	Warnings	Exact identifier application number: M017
Medicated Pain Relief Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	Kroger Company	47cc4b05-a937-4624-bf41-85b8bd7c049e	2026-03-12	Warnings	Exact identifier application number: M017
Lidocaine HCL	LIDOCAINE HCL	Matthias Therapeutics, LLC	4cdb27b5-9178-0328-e063-6394a90a50b5	2026-03-12	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