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 20 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stud 100 Male Genital Desensitizer	LIDOCAINE	Pound International Corp	d075656e-b13f-4a1d-bbb6-501e642698d5	2026-05-12	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	13ce57d0-b1c5-4685-ad7d-a562d9d8fc86	2026-05-12	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	CVS Pharmacy	db6f518d-3a0e-43f8-8d19-7382d9b7ff1c	2026-05-11	Warnings	Exact identifier application number: M017
Cool and Heat	MENTHOL	AMERISOURCE BERGEN	f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7	2026-05-11	Warnings	Exact identifier application number: M017
Instaflex Extra Strength Pain Relief Cream	MENTHOL, METHYL SALICYLATE	Healthy Directions, LLC	d058c64d-0e4f-45aa-8f52-804961b562e3	2026-05-11	Warnings	Exact identifier application number: M017
BonicaEaseX Hot Capsicum Pain Relieving	CAPSICUM	Planet (Anhui) Pharmaceutical Co.,Ltd	ca6e48af-af6d-4808-a576-0319d2080d38	2026-05-11	Warnings	Exact identifier application number: M017
BonicaEaseX Pain Relieving Lidocaine	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7486fe89-a377-4a37-997d-e3bd16b891a7	2026-05-11	Warnings	Exact identifier application number: M017
YYSDMVY NUMBING Cream	LIDOCAINE 4% NUMBING CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	5195f5ec-8524-77f5-e063-6294a90abdc2	2026-05-11	Warnings	Exact identifier application number: M017
Lightning X Burn Relief Gel	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	515eb4cc-63af-c11d-e063-6294a90a13ca	2026-05-09	Warnings	Exact identifier application number: M017
Albertson Lidocaine, Menthol Pain Relief Medicated Patch	LIDOCAINE AND MENTHOL	Safeway	dc647647-90ec-6beb-e053-2a95a90a7982	2026-05-09	Warnings	Exact identifier application number: M017
5 Elementum Lidocaine Male Genital Desensitizer	LIDOCAINE MALE GENITAL DESENSITIZER	MSVENTURESGROUP O	514b1738-886e-a95d-e063-6294a90aa707	2026-05-08	Warnings	Exact identifier application number: M017
Kroger Muscle Rub Cream	MENTHOL, CAMPHOR, METHYL SALICYLATE	Kroger Co.	45c8c79a-b4b4-d4be-e063-6394a90a9251	2026-05-08	Warnings	Exact identifier application number: M017
Walmart Equate Aloe Sunburn Relief Cooling	LIDOCAINE	WAL-MART STORES INC.	51540f6b-596f-bc47-e063-6294a90a46ae	2026-05-08	Warnings	Exact identifier application number: M017
Capsaicin 0.035% cream	CAPSAICIN	Medcore LLC	0236e1e4-c26c-4fff-a83b-143ce26d93bf	2026-05-07	Warnings	Exact identifier application number: M017
Lidocaine 4% Cream	LIDOCAINE	Medcore LLC	111cb421-ba3b-4772-ab60-d31eb4183168	2026-05-07	Warnings	Exact identifier application number: M017
Lidocaine 5% Cream	LIDOCAINE	Medcore LLC	15d02b42-bf8b-486a-a081-f6d17cc11ec7	2026-05-07	Warnings	Exact identifier application number: M017
JenGufun LIDOCAINE Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Kangdi Medical Devices Co., Ltd.	51363a41-5dcc-6a3b-e063-6294a90a6c27	2026-05-07	Warnings	Exact identifier application number: M017
Lidoxi	LIDOCAINE	T&T Pharma Holdings LLC	513c517e-c098-02aa-e063-6294a90ac8a4	2026-05-07	Warnings	Exact identifier application number: M017
Harris Teeter Hydrocortisone	HYDROCORTISONE	HARRIS TEETER LLC	4e8199f8-96ec-5342-e063-6294a90afb2d	2026-05-07	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc.	5114cdba-96a1-c399-e063-6294a90aac12	2026-05-06	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