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 139 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Bandage	LIDOCAINE	WellSpring Pharmaceutical Corporation	465dc46e-6435-4569-9516-f648d0fe0f09	2023-12-21	Warnings	Exact identifier application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	LABORATORIOS QUANTIUM LLC	c4efa317-8dd1-49e1-b7ca-9df2147edd3e	2023-12-21	Warnings	Exact identifier application number: M017
DDM Camphor Spirit	CAMPHOR 10%	Discount Drug Mart	5d56cbe6-4e48-79eb-e053-2a91aa0a74d3	2023-12-20	Warnings	Exact identifier application number: M017
Quality Choice Camphor Spirit	CAMPHOR 10%	Chain Drug Market Association	8d352a67-2024-43d0-b525-038d398949e6	2023-12-20	Warnings	Exact identifier application number: M017
Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Chain Drug Market Association	2cd60df3-bfde-4747-ba4f-7121612f2e63	2023-12-20	Warnings	Exact identifier application number: M017
Poison Ivy Wash	PRAMOXINE HCL	Chain Drug Market Association	873a546b-90ae-50cb-e053-2a91aa0adbfb	2023-12-20	Warnings	Exact identifier application number: M017
Premier Value Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharmacy Value Alliance LLC	9d63f8ed-fc50-0d84-e053-2a95a90a6e92	2023-12-20	Warnings	Exact identifier application number: M017
Ear Drops	CARBAMIDE PEROXIDE 6.5%	CVS Pharmacy	8a872991-01af-5fd0-e053-2995a90ac7f4	2023-12-20	Warnings	Exact identifier application number: M017
CVS Cold and Hot Roll-On	COOL AND HEAT PAIN RELIEF	CVS Pharmacy	b8cc578a-be6d-90c0-e053-2995a90a7742	2023-12-20	Warnings	Exact identifier application number: M017
Sunmark Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services LLC	667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa	2023-12-19	Warnings	Exact identifier application number: M017
DDM Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Discount Drug Mart	5d56c74f-604d-4fed-e053-2a91aa0a417c	2023-12-19	Warnings	Exact identifier application number: M017
HEB Camphor Phenol	CAMPHOR 10.8% AND PHENOL 4.7%	H E B	5d573883-001d-e5a4-e053-2991aa0a6203	2023-12-18	Warnings	Exact identifier application number: M017
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Exact identifier application number: M017
DermaWound Wound Care Venous Stasis	BENZOCAINE HYDROCHLORIDE	Progressive Doctors, LLC	6221ba86-8b7f-48c8-8284-6950f9fc36b1	2023-12-15	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	Humco Holding Group, Inc.	a8be9e46-1616-40a9-e053-2a95a90ac3bc	2023-12-15	Warnings	Exact identifier application number: M017
Hot/Cold Menthol 16% Roll-On	HOT/COLD MENTHOL 16% ROLL-ON	Humco Holding Group, Inc	a8bf9744-9979-13c1-e053-2a95a90a30aa	2023-12-15	Warnings	Exact identifier application number: M017
Freds Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Discount Drug Mart	8697b932-da5a-717e-e053-2a91aa0afcae	2023-12-12	Warnings	Exact identifier application number: M017
CVS Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	CVS	86972218-31fe-6942-e053-2991aa0a8850	2023-12-12	Warnings	Exact identifier application number: M017
Best Choice Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	value merchandisers	869631f8-aa1e-8ea4-e053-2a91aa0a5c57	2023-12-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Weeks & Leo Co., Inc.	0c5325e3-4796-856c-e063-6394a90a1f90	2023-12-12	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