MUSCLE EASE

Product NDC: 61577-2301
11-digit product format: 615772301
Labeler code: 61577
Product ID: 61577-2301_55928bab-8746-de18-e063-6394a90a7f64
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: 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

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…`

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: 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 134 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier application number: M017
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier application number: M017
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Exact identifier application number: M017
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Exact identifier application number: M017
meijer Cold Therapy Pain Relieving analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	fb163112-d84d-418d-a410-3214c0ee4b5a	2024-02-28	Warnings	Exact identifier application number: M017
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Exact identifier application number: M017
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Bryant Ranch Prepack	fcf48536-224e-4a3d-9124-770031823972	2024-02-22	Warnings	Exact identifier application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	8bc3956b-b82d-4ed3-8bc3-db0078466bbc	2024-02-22	Warnings	Exact identifier application number: M017
Promescent Delay Wipes	BENZOCAINE	Absorption	f0a5b6be-acc5-473c-9054-b9534e769db1	2024-02-20	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	721658dc-3b1d-43ff-9032-e96851633cf9	2024-02-19	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief Roll on	MENTHOL	Troy Manufacturing, Inc.	978d5c2c-fdc4-4d25-83ec-0b9404ec8018	2024-02-19	Warnings	Exact identifier application number: M017
1168	1168 BURN SPRAY	Dynarex Corporation	1183a4f5-f875-dfb0-e063-6394a90af35f	2024-02-16	Warnings	Exact identifier application number: M017
Pain Relief	BENZOCAINE	Safetec of America, Inc.	de84e598-d047-4fae-b2ed-155a3788bc6f	2024-02-16	Warnings	Exact identifier application number: M017
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	ab9bf09d-bc8c-6d17-e053-2995a90a6c36	2024-02-14	Warnings	Exact identifier application number: M017
Natures Oil 16% Menthol	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	2fbe23b7-23a3-4f0b-bc08-0205256f5d68	2024-02-14	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Rugby Laboratories	4c11876c-57ec-4429-a8c4-fb95baa4074a	2024-02-13	Warnings	Exact identifier application number: M017
Itch stopping Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	11368823-d4af-a536-e063-6294a90a7a2e	2024-02-12	Warnings	Exact identifier application number: M017
Walgreens Boil Pain Relief	BOIL PAIN RELIEF	Walgreens Company	d11bd769-68d0-4057-bc2a-72719f16011e	2024-02-12	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