SOMBRA COOL THERAPY

Product NDC: 61577-3103
11-digit product format: 615773103
Labeler code: 61577
Product ID: 61577-3103_4ffb85fd-c60e-3f70-e063-6294a90a6fdc
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: SOMBRA COSMETICS INC.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-21
Substance: MENTHOL
Active strength: .06 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 COOL THERAPY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	.06 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415976	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-3103-1	SOMBRA COOL THERAPY	85.05 g in 1 TUBE	GEL	85.05		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
FILIPENDULA ULMARIA FLOWER	INACTIVE INGREDIENT	06L18L32G6	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
GRAPEFRUIT SEED OIL	INACTIVE INGREDIENT	598D944HOL	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
LEMON PEEL	INACTIVE INGREDIENT	72O054U628	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
SODIUM HYDROXYMETHYLGLYCINATE	INACTIVE INGREDIENT	DIG6BWZ9XT	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1
YUCCA SCHIDIGERA ROOT	INACTIVE INGREDIENT	E2H9ET15AT	SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]	1

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 82 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Good Neighbor Roll-on Menthol Pain Relief Gel	MENTHOL	Amerisource Bergen	bd557323-0003-4ee6-b22d-a72d621c7de4	2025-08-05	Warnings	Exact identifier application number: M017
Earthmed FS Pain relieving balm	MENTHOL	Earthmed LLC	3ba4e769-fec6-52d9-e063-6394a90a65d4	2025-08-05	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	HF Acquisition Co LLC, DBA HealthFirst	3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6	2025-08-05	Warnings	Exact identifier application number: M017
Kocowo Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	3b82989d-7cc3-23d3-e063-6294a90ae2a3	2025-08-03	Warnings	Exact identifier application number: M017
Menthol pain relief patches	MENTHOL	Menthol pain relief patch	3b5fd718-3f86-f7a7-e063-6294a90a8c52	2025-08-02	Warnings	Exact identifier application number: M017
Graphene Far Infrared Herbal Pain Relief Patches	CORYDALIS RHIZOME	Changsha Maocheng Trading Co., Ltd	3b604a3c-fe91-7096-e063-6394a90afe04	2025-08-02	Warnings	Exact identifier application number: M017
Active Recovery Pain Relief	CAMPHOR, MENTHOL	Charlotte's Web, Inc.	3a9f9ca0-3d8a-796a-e063-6394a90a790c	2025-08-01	Warnings	Exact identifier application number: M017
Active Recovery Pain Relief Stick	CAMPHOR, MENTHOL	Charlottes Web, Inc.	3aa037c6-6109-b52e-e063-6394a90a215b	2025-08-01	Warnings	Exact identifier application number: M017
PM Recovery Pain Relief	CAMPHOR, MENTHOL	Charlotte's Web, Inc.	3aa08859-809d-de8c-e063-6394a90a8e25	2025-08-01	Warnings	Exact identifier application number: M017
Wish ultra winter ice	MENTHOL	LJ Pharma	b4c5487c-1314-4d63-96df-077e72e7ee95	2025-08-01	Warnings	Exact identifier application number: M017
Rugged Fit Pain Relief Roll On	MENTHOL, METHYL SALICYLATE	SYSTEM4BOOK LLC	39d68734-981c-14d7-e063-6294a90a4919	2025-08-01	Warnings	Exact identifier application number: M017
ICY FREEZE	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	28fdb049-b297-4358-9447-7d69ba879702	2025-08-01	Warnings	Exact identifier application number: M017
Cortizone 10 Cooling	HYDROCORTISONE	Chattem, Inc.	14d9fce2-9f54-4204-83cb-161de8a303f0	2025-08-01	Warnings	Exact identifier application number: M017
Bravado Labs Numbing	LIDOCAINE HCL	Prodigy Media Inc	8c43f5b5-b911-4a7a-b2d1-56a09c54b001	2025-07-30	Warnings	Exact identifier application number: M017
Chimera GUARD	LIDOCAINE PAIN RELIEFING PATCH	Hangzhou Rongna Health Technology Co., Ltd.	3721c984-1993-6265-e063-6394a90af23f	2025-07-29	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415976	menthol 6 % Topical Gel	PSN	87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	12
415976	menthol 0.06 MG/MG Topical Gel	SCD	87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	12
415976	menthol 6 % Topical Gel	SY	87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61577-3103-1	61577310301	85.05 g in 1 TUBE (61577-3103-1)	85.05 g	2026-04-21	No	No	Current