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 103 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Exact identifier application number: M017
elp essential MANTECA DE UBRE	METHYL SALICYLATE, CAMPHOR	Miramar Cosmetics, Inc DBA Miramar Lab	c3964dfe-17fe-4d89-a4c4-cf500f982259	2025-01-13	Warnings	Exact identifier application number: M017
Methylten	METHYL SALICYLATE 10%	Puretek Corporation	28f4093f-803f-0e70-e063-6294a90a98a4	2025-01-13	Warnings	Exact identifier application number: M017
Refill Bundle 7 Large Office	BENZALKONIUM CHLORIDE	CMC Group, Inc.	6620a8f3-098d-d045-e053-2a91aa0a0d94	2025-01-13	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba1de83-494a-6c54-e063-6294a90a9b2d	2025-01-13	Warnings	Exact identifier application number: M017
Arthritis Hot	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd	2025-01-13	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b40dda-53ad-0458-e063-6394a90aa835	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b47eb7-6b43-d9e2-e063-6294a90a9a38	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 4% Lidocaine Fabric Tape	LIDOCAINE 4% FABRIC TAPE	Transfer Technology	e9a894b0-54f2-707e-e053-2a95a90a0f0d	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 3 in 1 Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH	Transfer Technology	e9ab9a03-b9e3-7317-e053-2995a90a9950	2025-01-11	Warnings	Exact identifier application number: M017
ASTRAPHARM CHILLI BRAND	CAPSAICIN	Dersan Pharmaceutical Co., Ltd	b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec	2025-01-10	Warnings	Exact identifier application number: M017
LABOFLEX Lidocaine Pain Relieving Patch	LIDOCAINE 4%	Laboflex, Inc.	31995f31-c272-afdb-e063-6294a90af3f9	2025-01-10	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Chain Drug Marketing Association Inc.	2b48cb2f-e6bf-f9de-e063-6394a90a42d4	2025-01-09	Warnings	Exact identifier application number: M017
PAIN-X	MENTHOL	OL PHARMA TECH,LLC	b22bb19a-14e5-3d32-e053-2a95a90ae520	2025-01-09	Warnings	Exact identifier application number: M017
MUSCLE RUB	MENTHOL	OL PHARMA TECH,LLC	b22c7999-52d5-25c3-e053-2a95a90a01f5	2025-01-09	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	ce392c4f-cc43-484d-9c49-18fa25e4e5e9	2025-01-09	Warnings	Exact identifier application number: M017
NEW TEROCIN	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	A-S Medication Solutions	43e5eb27-5541-4b7b-80de-55a79a4dce55	2025-01-09	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	cbeac814-59d8-4c13-8e73-bca66f797f8d	2025-01-09	Warnings	Exact identifier application number: M017
Bactine Max	LIDOCAINE	WellSpring Pharmaceutical Corporation	acd7ae37-7c42-4ec7-a2ef-42e7f628388d	2025-01-08	Warnings	Exact identifier application number: M017
THERABLAST MAXIMUM RELIEF	LIDOCAINE, MENTHOL	Releaf Technologies LLC	09809985-3a88-9bb7-e063-6394a90a2f5f	2025-01-08	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