MUSCLE EASE

Product NDC: 61577-2301
11-digit product format: 615772301
Labeler code: 61577
Product ID: 61577-2301_364d56a8-599d-1bfe-e063-6394a90a1354
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: 2011-12-16
Substance: CAMPHOR (SYNTHETIC); MENTHOL
Active strength: .03; .03 g/g; g/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-2301-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61577-2301-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-2301-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61577-2301-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-2301-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61577-2301-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-2301-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61577-2301-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-2301-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61577-2301-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-2301-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61577-2301-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61577-2301-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61577-2301-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Additional Listing Data#

Finished product: Yes
Brand name base: MUSCLE EASE
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
630714	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
03fff4bf-04ed-49a6-b40f-4d98c2b42f69	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61577-2301-2	2025-01-30	Muscle Ease
61577-2301-2	2025-01-30	Muscle Ease
61577-2301-4	2025-01-30	Muscle Ease
61577-2301-4	2025-01-30	Muscle Ease
61577-2301-2	2023-02-14	Muscle Ease
61577-2301-2	2023-02-14	Muscle Ease
61577-2301-4	2023-02-14	Muscle Ease
61577-2301-4	2023-02-14	Muscle Ease
61577-2301-2	2023-01-30	Muscle Ease
61577-2301-2	2023-01-30	Muscle Ease
61577-2301-4	2023-01-30	Muscle Ease
61577-2301-4	2023-01-30	Muscle Ease
61577-2301-2	2020-03-06	Muscle Ease
61577-2301-2	2020-03-06	Muscle Ease
61577-2301-4	2020-03-06	Muscle Ease
61577-2301-4	2020-03-06	Muscle Ease
61577-2301-2	2020-01-31	Muscle Ease
61577-2301-2	2020-01-31	Muscle Ease
61577-2301-4	2020-01-31	Muscle Ease
61577-2301-4	2020-01-31	Muscle Ease

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-2301-2	MUSCLE EASE	56.7 g in 1 TUBE	GEL	56.7		7
61577-2301-4	MUSCLE EASE	113.4 g in 1 JAR	GEL	113.4		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
CAPSICUM	INACTIVE INGREDIENT	00UK7646FG	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
FILIPENDULA ULMARIA FLOWER	INACTIVE INGREDIENT	06L18L32G6	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
GRAPEFRUIT SEED OIL	INACTIVE INGREDIENT	598D944HOL	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
ORANGE PEEL	INACTIVE INGREDIENT	TI9T76XD44	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
SODIUM HYDROXYMETHYLGLYCINATE	INACTIVE INGREDIENT	DIG6BWZ9XT	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2
YUCCA SCHIDIGERA ROOT	INACTIVE INGREDIENT	E2H9ET15AT	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-2301	MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]	6	Current NDC, Legacy NDC, 2 package rows	20230215_03fff4bf-04ed-49a6-b40f-4d98c2b42f69.zip

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 1 of 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Cardinal Health, 110 dba Leader	3ed7b8a1-012f-459d-878c-813b93d4673c	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Gel Cooling Pain Relief	MENTHOL	The Kroger Co.	6fb0acc8-8dab-452c-b09e-de97306e1c32	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Lidocaine Tattoo Wipe	LIDOCAINE HYDROCHLORIDE	MD Tattoo Company	369c1d16-597c-e1dc-e063-6394a90a3104	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	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)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630714	camphor 3 % / menthol 3 % Topical Gel	PSN	03fff4bf-04ed-49a6-b40f-4d98c2b42f69	7
630714	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel	SCD	03fff4bf-04ed-49a6-b40f-4d98c2b42f69	7
630714	camphor 3 % / menthol 3 % Topical Gel	SY	03fff4bf-04ed-49a6-b40f-4d98c2b42f69	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-2301-2	61577230102	56.7 g in 1 TUBE (61577-2301-2)	56.7 g	2014-02-21	0000-00-00	No	No	Current
61577-2301-4	61577230104	113.4 g in 1 JAR (61577-2301-4)	113.4 g	2014-02-21	0000-00-00	No	No	Current