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 37 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF PATCHES	LIDOCAINE	WALMART STORES INC	b82cfe42-f521-4784-8c60-98481524c5ec	2026-01-29	Warnings	Exact identifier application number: M017
Equate Pain Relief Patch Camphor/Menthol/Salicylate	CAMPHOR, MENTHOL, METHYL SALICYLATE	Walmart Stores Inc	b869848c-21e2-5ca2-e053-2995a90a86f2	2026-01-29	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	498cd2aa-ee59-67b5-e063-6294a90ac242	2026-01-29	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	498d76d8-788b-4cc7-e063-6294a90a1696	2026-01-29	Warnings	Exact identifier application number: M017
MQUPIN Lidocaine Gel-Patch	LIDOCAINE GEL-PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	49703717-69a6-e480-e063-6394a90ac69c	2026-01-28	Warnings	Exact identifier application number: M017
MQXUNMI LIDOCAINE Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	49706db7-bacd-190f-e063-6394a90a3a8e	2026-01-28	Warnings	Exact identifier application number: M017
Joint and Muscle Relief Topical Analgesic	MENTHOL	Smart Cookie Solutions	1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d	2026-01-28	Warnings	Exact identifier application number: M017
VonaFlex Effective Pain Relief Topical Analgesic	LIDOCAINE HYDROCHLORIDE	OPTIMAL LABORATORIES, LLC	0901244a-7d41-413a-b424-92a807532f28	2026-01-28	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF	Dynarex	960e4240-cd09-2560-e053-2a95a90a7bcf	2026-01-28	Warnings	Exact identifier application number: M017
ALOE ICE SUNBURN RELIEF	LIDOCAINE HYDROCHLORIDE	Aloe Care International, LLC	56866fa8-052e-497c-a954-978d7d628949	2026-01-28	Warnings	Exact identifier application number: M017
Walgreens Original Strength Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Walgreen Company	a6a49dbb-74c7-47ca-88f2-3bb3d9acf914	2026-01-28	Warnings	Exact identifier application number: M017
Flobow QUIT SMOKING Nicotine	NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE	Jiangxi Yudexi Pharmaceutical Co., LTD	495b10ce-3d2d-1aa4-e063-6294a90a4f35	2026-01-27	Warnings	Exact identifier application number: M017
PAIN	REUSEABLE PAIN	Shenzhen Mengyue Technology Co., Ltd.	44e058fc-e1c0-742b-e063-6294a90ad225	2026-01-27	Warnings	Exact identifier application number: M017
HealthWise Pain Relieving Cream Lavender	MENTHOL	Veridian Healthcare	495eb6e9-69da-f7b6-e063-6294a90accee	2026-01-27	Warnings	Exact identifier application number: M017
HealthWise Pain Relieving Cream	MENTHOL	Veridian Healthcare	49548ab2-267e-1e2a-e063-6394a90ab391	2026-01-27	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores, Inc.	03feaaef-7401-d464-e063-6294a90a2b2d	2026-01-27	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	4a113699-1eb7-49b8-8cdf-2ad57db89b81	2026-01-27	Warnings	Exact identifier application number: M017
Healthy Back Institute Rub On Relief	ANALGESIC	Fullstack Fulfillment	284c29a3-5722-ce70-e063-6394a90a7fa0	2026-01-26	Warnings	Exact identifier application number: M017
Velocx for Joint and Muscle Pain Roll-On Applicator	MENTHOL, METHYL SALICYLATE	JMAD Consulting LLC, dba JMAD Labs	dbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d21	2026-01-26	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	CAPSAICIN	Meijer Distribution Inc	9b91658f-c15f-4222-bbd9-881b29de3b6e	2026-01-26	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