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 88 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SupreH Bee Venom Arthritis Pain Relieving Cream	SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3876cc44-7f3a-b084-e063-6294a90a6142	2025-06-26	Warnings	Exact identifier application number: M017
MediBalm	HYDROCORTISONE	BalmRx, LLC	324dd151-84c5-3e2f-e063-6394a90a569d	2025-06-26	Warnings	Exact identifier application number: M017
PHIZICO Pain Relief	MENTHOL	ER3 BRANDS INC.	72715dc5-d1e7-4b4b-8e28-4e367abba322	2025-06-25	Warnings	Exact identifier application number: M017
Diva Cramp Care Cream	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	37368566-b14e-4d5c-bdde-6eea9073974f	2025-06-25	Warnings	Exact identifier application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH	LIDOCAINE HCL	H2Ocean, LLC	386bf11b-1d71-44bf-e063-6394a90a2817	2025-06-25	Warnings	Exact identifier application number: M017
Burn Relief Extra Strength Kool-Down	LIDOCAINE - 3.9%	Kool-Down Inc	827fec2f-db3c-adbb-e053-2a91aa0a7c17	2025-06-25	Warnings	Exact identifier application number: M017
Hilook Blue Gel Anesthetic	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9db681-a297-5aa9-e063-6394a90a80ea	2025-06-25	Warnings	Exact identifier application number: M017
Hilook Numbing Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9f1a4c-ca0b-d820-e063-6394a90a3239	2025-06-25	Warnings	Exact identifier application number: M017
Lidocaine Knee Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	384c1ff8-80bd-86cb-e063-6394a90a2d65	2025-06-24	Warnings	Exact identifier application number: M017
Aroamas Cot Nicotine Transdermal Patches Kit	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	38576022-9413-c9af-e063-6294a90afd46	2025-06-24	Warnings	Exact identifier application number: M017
NERVE REVERSE PAIN RELIEF	MENTHOL	Pogue Medical Services	da97bcc6-5aa8-48e2-a2c2-c937745bf6d3	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief Menthol Roll-On	MENTHOL	Respect Manufacturing Corporation	05a6067a-287a-52d4-e063-6394a90a2c4e	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief 500mg Hemp Menthol Cream	MENTHOL	Respect Manufacturing Corporation	06c4640a-ee42-5d1a-e063-6394a90ad254	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief 1000mg Hemp Menthol Cream	MENTHOL	Respect Manufacturing Corporation	06e944e8-71f6-9fe9-e063-6294a90a8c37	2025-06-23	Warnings	Exact identifier application number: M017
Procure gel	MENTHOL	TWIN MED, LLC	e69c0b68-d408-9fd2-e053-2a95a90ac934	2025-06-20	Warnings	Exact identifier application number: M017
A Health Itch Relief Gel	ITCH RELIEF GEL	Bionpharma, Inc.	38040732-48c9-3533-e063-6394a90af10a	2025-06-20	Warnings	Exact identifier application number: M017
SCHOELIF Numbing Cream	NUMBING CREAM	Guangzhou Qiexiran Cosmetics Co., Ltd.	37eaabb7-884e-0bd5-e063-6294a90ae063	2025-06-19	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37ee539c-df7e-511d-e063-6394a90a4469	2025-06-19	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37eef80a-556f-b090-e063-6294a90a151b	2025-06-19	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37ef02d4-2ff5-cb23-e063-6294a90a68af	2025-06-19	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