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 41 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Hydrocortisone Cream with Aloe	HYDROCORTISONE CREAM	Walgreens	e8f69c4b-2570-477e-9c6d-d552d30ac0d0	2026-01-14	Warnings	Exact identifier application number: M017
Hydrocortisone	COOL RELIEF GEL WITH ALOE	Walgreens	1ae2b37d-d5b2-74d2-e063-6294a90a0de0	2026-01-14	Warnings	Exact identifier application number: M017
Maximum Strength Cortisone Cream with Aloe	HYDROCORTISONE CREAM	CVS Pharmacy	b95d30b0-6ebd-4989-a6ac-1a42e5d4aba5	2026-01-14	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Cream with Aloe	HYDROCORTISONE CREAM	Walgreens	61b93226-10ff-43df-b1b6-bcea917a2f48	2026-01-14	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Cream	HYDROCORTISONE CREAM	Walgreens	2112067c-0fbb-400c-9923-b932946e1a12	2026-01-14	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Cream	HYDROCORTISONE CREAM	Walgreens	a7db0a6f-ceca-4e77-bad7-55c3c74413a7	2026-01-14	Warnings	Exact identifier application number: M017
CVS Therapeutic Menthol Gel	MENTHOL	CVS Pharmacy	a02605cd-40d1-4ea1-9828-0695f2d123aa	2026-01-14	Warnings	Exact identifier application number: M017
Maximum Strength Cortisone	HYDROCORTISONE OINTMENT	CVS Pharmacy	f25f2e14-4fc9-4c92-880d-e5f9279d4ecd	2026-01-14	Warnings	Exact identifier application number: M017
Icy Hot with Lidocaine No-Mess	MENTHOL AND LIDOCAINE	Chattem, Inc.	a2803c07-bf39-4028-9262-5082da25b46e	2026-01-14	Warnings	Exact identifier application number: M017
Cortisone 10 Intensive Moisture Creme	HYDROCORTISONE	Chattem, Inc.	096a9af3-7e7c-4dae-bc22-44061c60d3c9	2026-01-14	Warnings	Exact identifier application number: M017
Icy Hot Dry	MENTHOL	Chattem, Inc.	720a85cc-8e98-43f2-9cc8-5636ae09624f	2026-01-14	Warnings	Exact identifier application number: M017
Gold Bond Extra Strength	MENTHOL	Chattem, Inc.	98ea15e6-972f-44a3-a1e4-abeae538d5a7	2026-01-14	Warnings	Exact identifier application number: M017
Timing Pain Savior Fragrant Ginger Patch	MENTHOL, METHYL SALICYLATE	Timing Pharmaceutical Co., Ltd PABP Branch	a0308e0e-1b47-42ab-88ac-b71ff3fa6c47	2026-01-14	Warnings	Exact identifier application number: M017
Cortizone 10 Easy Relief	HYDROCORTISONE	Chattem, Inc.	beb73818-cd88-44ff-8ecd-b02b910b53b7	2026-01-14	Warnings	Exact identifier application number: M017
diphenhydramine hcl and zinc acetate	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Padagis Israel Pharmaceuticals Ltd	6d7a7615-9ae7-4c55-8a84-dba746f535d7	2026-01-14	Warnings	Exact identifier application number: M017
Timing Pain Savior Cool Herbal Patch	MENTHOL, METHYL SALICYLATE	Timing Pharmaceutical Co., Ltd PABP Branch	3b260be8-5e2a-4fba-85d6-2e6c64b97076	2026-01-14	Warnings	Exact identifier application number: M017
Cortizone 10 Feminine Itch Relief	HYDROCORTISONE	Chattem, Inc.	c0c0c1fb-43c9-4903-bb3b-f0885619b8cc	2026-01-14	Warnings	Exact identifier application number: M017
Icy Hot Pro Pain Relief Cream w/ microbeads	MENTHOL, CAMPHOR	Chattem, Inc.	df5fd485-f583-46b7-a869-16ca2e17185c	2026-01-14	Warnings	Exact identifier application number: M017
Cortizone 10 Ultra Soothing Creme	HYDROCORTISONE	Chattem, Inc.	4b62615f-e713-42f2-8b9c-9eebf8d1b270	2026-01-14	Warnings	Exact identifier application number: M017
Gold Bond Medicated Pain and Itch Relief	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	5767362c-83af-494e-a815-a13f2cb093ef	2026-01-14	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