FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
MUSCLE EASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).03 g/g
MENTHOL.03 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A
Rxcui630714

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-2301-22025-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42025-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22023-02-14C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42023-02-14C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22023-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42023-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22020-03-06C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42020-03-06C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22020-01-31C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42020-01-31C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle 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

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
61577-2301-461577230104113.4 g in 1 JAR (61577-2301-4) 113.4 g2014-02-210000-00-00NoNoCurrent