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 63 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
After Bite Outdoor	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	22b891a9-6386-dee1-e063-6394a90a5c2f	2025-11-14	Warnings	Exact identifier application number: M017
QR PAIN	ANALGESIC	MARYHELENE ENTERPRISES INC	8f8f53e3-fe31-e7b5-e053-2995a90a710d	2025-11-14	Warnings	Exact identifier application number: M017
QR PAIN	ANALGESIC	MARYHELENE ENTERPRISES INC	9984a510-30be-4013-e053-2995a90a841e	2025-11-14	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger	3f881349-fcdd-e276-e063-6394a90ae49e	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434cb8b2-a996-5360-e063-6394a90ada03	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	4360e3ec-7a4b-b28e-e063-6294a90a0bd6	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	4360e3be-0ec4-cd57-e063-6394a90aca63	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	43616ad7-58bb-e5ad-e063-6394a90a192b	2025-11-13	Warnings	Exact identifier application number: M017
4x Medicated Severe Toothache and Gum Gel	BENZALKONIUM CHLORIDE	Meijer	97ce7890-5093-1763-e053-2a95a90afae7	2025-11-13	Warnings	Exact identifier application number: M017
Pain Reliever	CAMPHOR, MENTHOL	Kool 'N Fit Inc.	2253f6bd-5707-b993-e063-6394a90aa74a	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	4360e0d1-46cd-ab4b-e063-6394a90a55e1	2025-11-12	Warnings	Exact identifier application number: M017
CVS Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	CVS	8723e097-296f-784a-e053-2991aa0a552e	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154d8821-3e76-b0e2-e063-6294a90ae077	2025-11-12	Warnings	Exact identifier application number: M017
Good neighbor Pharmacy Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	AMERISOURCEBERGEN DRUG CORPORATION	87395273-380c-7cef-e053-2991aa0a54c6	2025-11-12	Warnings	Exact identifier application number: M017
Quality Choice Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Chain Drug Marketing Association	8735b298-83f3-0b5d-e053-2a91aa0a8292	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	1550e794-b3c0-4769-e063-6294a90a8c2d	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154fd46e-f00d-1772-e063-6394a90aba7d	2025-11-12	Warnings	Exact identifier application number: M017
Best Choice Itch Stopping	DIPHENHYDRAMINE HCL	Valu Merchandisers	884cfd64-2cd1-8c12-e053-2995a90a8925	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	CVS	8839149d-e6d5-57cc-e053-2995a90a9832	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	Chain Drug Marketing Association	884c9b47-d511-1d17-e053-2995a90a42eb	2025-11-12	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