FDA.reportPublic FDA data

MUSCLE EASE

Product NDC
61577-2301
Requested package NDC
61577-2301-2
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
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
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
630714Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03fff4bf-04ed-49a6-b40f-4d98c2b42f69Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61577-2301-22025-01-30Muscle Ease
61577-2301-22025-01-30Muscle Ease
61577-2301-42025-01-30Muscle Ease
61577-2301-42025-01-30Muscle Ease
61577-2301-22023-02-14Muscle Ease
61577-2301-22023-02-14Muscle Ease
61577-2301-42023-02-14Muscle Ease
61577-2301-42023-02-14Muscle Ease
61577-2301-22023-01-30Muscle Ease
61577-2301-22023-01-30Muscle Ease
61577-2301-42023-01-30Muscle Ease
61577-2301-42023-01-30Muscle Ease
61577-2301-22020-03-06Muscle Ease
61577-2301-22020-03-06Muscle Ease
61577-2301-42020-03-06Muscle Ease
61577-2301-42020-03-06Muscle Ease
61577-2301-22020-01-31Muscle Ease
61577-2301-22020-01-31Muscle Ease
61577-2301-42020-01-31Muscle Ease
61577-2301-42020-01-31Muscle Ease

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-2301-2MUSCLE EASE56.7 g in 1 TUBEGEL56.77
61577-2301-4MUSCLE EASE113.4 g in 1 JARGEL113.47

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3AMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
CAPSICUMINACTIVE INGREDIENT00UK7646FGMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOLMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
ORANGE PEELINACTIVE INGREDIENTTI9T76XD44MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWYMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
WITCH HAZELINACTIVE INGREDIENT101I4J0U34MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15ATMUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-2301MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]6Current NDC, Legacy NDC, 2 package rows20230215_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 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630714camphor 3 % / menthol 3 % Topical GelPSN03fff4bf-04ed-49a6-b40f-4d98c2b42f697
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCD03fff4bf-04ed-49a6-b40f-4d98c2b42f697
630714camphor 3 % / menthol 3 % Topical GelSY03fff4bf-04ed-49a6-b40f-4d98c2b42f697

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-2301-26157723010256.7 g in 1 TUBE (61577-2301-2) 56.7 g2014-02-210000-00-00NoNoCurrent