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 81 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine 3%	LIDOCAINE HCL 3%	PureTek Corporation	3bc94d52-fe52-9fd6-e063-6294a90a4340	2025-08-12	Warnings	Exact identifier application number: M017
Fast Freeze	MENTHOL	Natural Essentials Inc.	d8c42c8d-6ce0-43bf-b165-41979f3d8f79	2025-08-12	Warnings	Exact identifier application number: M017
Careland X-large Lidocaine 4 Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	a6867506-4a46-47b1-b5b6-bfedb59dfde6	2025-08-11	Warnings	Exact identifier application number: M017
Dermedial Anti-Ouch	MENTHOL	Saje Natural Business Inc.	3c194b8f-cfa5-11e3-e063-6394a90a92de	2025-08-11	Warnings	Exact identifier application number: M017
Thera Plus Extra Strength Muscle Rub Topical Analgesic	MENTHOL	FOURSTAR GROUP USA, INC.	8a3b6adf-afbb-4d77-a19b-a6514ebd3b50	2025-08-11	Warnings	Exact identifier application number: M017
EARTHS CARE ARTHRITIS	CAPSAICIN	DLC Laboratories, Inc.	9460674b-057e-40b9-a0f9-ca3d92068d4f	2025-08-11	Warnings	Exact identifier application number: M017
LILAS PERIOD	MENTHOL	Lilas Wellness, Inc.	5ea53b4b-45e6-48a7-8090-09c3a21e7f63	2025-08-11	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Roll-On	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	31639407-0f11-bde2-e063-6294a90af694	2025-08-10	Warnings	Exact identifier application number: M017
Chinese Red Tiger Lidocaine Patches	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	20cd369c-3e98-3d8f-e063-6394a90a0824	2025-08-10	Warnings	Exact identifier application number: M017
Treatonic LIDOCAINE PAIN RELIEF	LIDOCAINE 4%	100 KARMA INC	3bd66b03-ac82-2d45-e063-6294a90a610a	2025-08-08	Warnings	Exact identifier application number: M017
Capsaicin 0.025%	CAPSAICIN 0.025%	Advanced Rx of Tennessee, LLC	3bdcef94-d06f-9152-e063-6294a90a6072	2025-08-08	Warnings	Exact identifier application number: M017
MENTHOL 5%	MENTHOL 5%	Advanced Rx of Tennessee, LLC	3bdd0c52-29d8-ab67-e063-6294a90a9c45	2025-08-08	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	Advanced Rx of Tennessee, LLC	3bdd3015-349a-0fac-e063-6394a90afe41	2025-08-08	Warnings	Exact identifier application number: M017
LIDOCAINE 4%	LIDOCAINE 4%	Advanced Rx of Tennessee, LLC	3bdd6b3d-7180-288c-e063-6394a90a1785	2025-08-08	Warnings	Exact identifier application number: M017
Good Sense Pain Relief Roll On	LIDOCAINE HCL	Geiss, Destin & Dunn, Inc	38e76fd6-e5fb-493c-e063-6294a90afed4	2025-08-08	Warnings	Exact identifier application number: M017
Aruba Aloe Alcoholada	LIDOCAINE HYDROCHLORIDE	Aruba Aloe Balm NV	f56c62b0-75db-4499-858e-54e10b0e140a	2025-08-07	Warnings	Exact identifier application number: M017
SurviveX Hydrocortisone Cream	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	3bd1da8d-5142-798c-e063-6294a90a7be6	2025-08-07	Warnings	Exact identifier application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGE	SOOTHING PAIN RELIEF MASSAGE	Beijing JUNGE Technology Co., Ltd.	3524ad62-0ed6-f2e5-e063-6394a90a3283	2025-08-06	Warnings	Exact identifier application number: M017
Alumier MD Intensive Recovery	HYDROCORTISONE	Alumier Labs	d9b79ea1-6558-543c-e053-2995a90ae53e	2025-08-06	Warnings	Exact identifier application number: M017
Good Neighbor Roll-on Pain Relief	LIDOCAINE HCL	Amerisource Bergen	a0c3adbf-fa35-47c0-9db3-459ce9a106ac	2025-08-06	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