FDA.reportPublic FDA data

Professional Therapy MuscleCare Pro

Product NDC
70039-302
11-digit product format
700390302
Labeler code
70039
Product ID
70039-302_1794c494-425d-3eee-e063-6394a90aa08d
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
ACTIVE AND INNOVATIVE, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-03
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
4; 10 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Professional Therapy MuscleCare Pro
Brand name suffix
Pain Relieving Cold Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)4 g/100g
MENTHOL10 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A
Rxcui1039731

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70039-302-16Professional Therapy MuscleCare ProPain Relieving Cold Gel453 g in 1 BOTTLE, PUMPGEL4535
70039-302-32Professional Therapy MuscleCare ProPain Relieving Cold Gel906 g in 1 BOTTLE, PUMPGEL9065

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70039-302PROFESSIONAL THERAPY MUSCLECARE PRO PAIN RELIEVING COLD GEL (CAMPHOR, MENTHOL) GEL [ACTIVE AND INNOVATIVE, LLC]5Current NDC, 2 package rows20240504_1794c512-5f42-4ec3-e063-6394a90a87cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSN1794c512-5f42-4ec3-e063-6394a90a87cd5
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD1794c512-5f42-4ec3-e063-6394a90a87cd5
1039731camphor 4 % / menthol 10 % Topical GelSY1794c512-5f42-4ec3-e063-6394a90a87cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70039-302-1670039030216453 g in 1 BOTTLE, PUMP (70039-302-16) 453 g2024-05-03NoNoHistorical
70039-302-3270039030232906 g in 1 BOTTLE, PUMP (70039-302-32) 906 g2024-05-03NoNoHistorical