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

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
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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039731Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1794c512-5f42-4ec3-e063-6394a90a87cdAvailable on FDA.report

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

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 106 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.44d3638d-f29b-0e01-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONERugby Laboratories132982ea-cce6-687c-e063-6294a90a46322024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLC9bb98452-a605-5c20-e053-2995a90a1ea72024-12-20WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 10.5%Derma Care Research Labs, LLC00dcdae0-c744-8402-e063-6294a90a12f82024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLCab95e606-69f0-1d58-e053-2a95a90a073b2024-12-20WarningsExact identifier
application number: M017
Itch Relief CreamZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%Pharmacy Value Alliance LLC37fe6d82-adee-4f58-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Warrior First Aid Anti ItchDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCec6e9a5b-c61d-a385-e053-2995a90ac9362024-12-20WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE HCLDerma Care Research Labs, LLCff227154-cf3b-9796-e053-6294a90a55352024-12-20WarningsExact identifier
application number: M017
Outback Pain ReliefCAMPHOR 6%, MENTHOL 16%Derma Care Research Labs, LLCc238c930-2012-2d48-e053-2a95a90a8a4a2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE HCL 4%Meijerf31b11ed-2ff9-5cfc-e053-2a95a90af2ca2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefMENTHOL 10.5%Meijerbed81975-bd63-cf5b-e053-2995a90ac5fa2024-12-20WarningsExact identifier
application number: M017
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE 4%Meijerbed67c31-c479-6f9b-e053-2a95a90a55162024-12-20WarningsExact identifier
application number: M017
Blue-Emu Ultra with Hemp SeedTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa92024-12-20WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e4d9bc32-ac85-349f-e053-2995a90a032f2024-12-19WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e5f3edc2-1b79-533a-e053-2a95a90ae9b62024-12-19WarningsExact identifier
application number: M017
LeaderLIDOCAINE HCLCardinal Healthcea6bd2d-a265-1209-e053-2995a90ab0a52024-12-19WarningsExact identifier
application number: M017
Rugby Anti-ItchCAMPHOR, MENTHOLRUGBY LABORATORIES99d8ad9e-46ec-15fc-e053-2995a90a0d172024-12-19WarningsExact identifier
application number: M017

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 g2024-05-03NoNoCurrent
70039-302-3270039030232906 g in 1 BOTTLE, PUMP (70039-302-32) 906 g2024-05-03NoNoCurrent