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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	LIDOCAINE 4% GEL PATCH	Dr. Sabharwal's Wound Care	102399b6-5be9-ee5e-e063-6394a90a3198	2026-04-02	Warnings	Exact identifier application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVING	LIDOCAINE HYDROCHLORIDE	Scyberco Ltd	ac8eac04-ed5b-4c8e-9f9b-54d160b74606	2026-04-02	Warnings	Exact identifier application number: M017
FifthPulse Hydrocortisone	HYDROCORTISONE	WeCare Products LLC	f1fcb045-4a15-431b-9617-67eae9f87fbd	2026-04-02	Warnings	Exact identifier application number: M017
ANIXIKE Cream	MENTHOL 5% CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4e8510e6-c0c7-bf6b-e063-6294a90a3b00	2026-04-02	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	83569	4ed549e8-0062-fb03-e063-6294a90aac65	2026-04-02	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	CVS Pharmacy	7e921988-ec66-38dc-e053-2a91aa0a7346	2026-04-01	Warnings	Exact identifier application number: M017
The Best Numbing Cream	TBNC	The Best Numbing Cream LLC	4ca3923b-f586-0aaf-e063-6294a90a16c1	2026-03-31	Warnings	Exact identifier application number: M017
ChapStick Classic Medicated	EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42798a6c-2d7e-80f6-e063-6294a90a105f	2026-03-31	Warnings	Exact identifier application number: M017
Roll-On Pain Relief Liquid	LIDOCAINE HCL	HyVee Inc	4da6f6fb-b182-360f-e063-6294a90abdf3	2026-03-31	Warnings	Exact identifier application number: M017
Hand Sanitizer	ALCOHOL	ProStat First Aid	4e54aecb-190f-3866-e063-6294a90a810a	2026-03-31	Warnings	Exact identifier application number: M017
Burn Mist	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	c53ab9dd-351a-400b-b873-4f396e0af54d	2026-03-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving	LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	f7faddb2-5153-4fdd-a5ef-778182cef460	2026-03-31	Warnings	Exact identifier application number: M017
ZENOL COOL	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4e5c45f4-88ce-3a13-e063-6394a90a2a09	2026-03-31	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	091451fb-e30a-0012-e063-6394a90a3ba8	2026-03-31	Warnings	Exact identifier application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint	MENTHOL	Chattem, Inc.	b16ba9c2-23bf-4fdf-b44b-7abb9fec1911	2026-03-31	Warnings	Exact identifier application number: M017
DR.PABU NUMBING	LIDOCAINE 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4e3a3c6c-4821-76ea-e063-6294a90a8f96	2026-03-30	Warnings	Exact identifier application number: M017
Doctor Jiao Antifungal Cream	MICONAZOLE NITRATE	Jiangxi Haiwei Pharmaceutical Co., Ltd.	4e3b231e-0642-bf63-e063-6394a90a905b	2026-03-30	Warnings	Exact identifier application number: M017
CVS Muscle Balm and Roll-On	CAMPHOR, MENTHOL	CVS Pharmacy	4e40025a-070a-508e-e063-6394a90af5d7	2026-03-30	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	c3eec066-38e8-4617-b34d-2f72ffb7a324	2026-03-30	Warnings	Exact identifier application number: M017
Softlips Naturals Medicated Matcha Honey	CAMPHOR, MENTHOL	The Mentholatum Company	4e03a721-73f3-b2f2-e063-6394a90a44e6	2026-03-27	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