FDA.reportPublic FDA data

Ultra Strength Muscle Rub - CVS Health

Product NDC
51316-982
11-digit product format
513160982
Labeler code
51316
Product ID
51316-982_4dd2dbc5-3720-f324-e063-6294a90af033
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol, methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-15
Substance
CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL
Active strength
40; 300; 100 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Ultra Strength Muscle Rub - CVS Health
Brand name suffix
Ultra Strength Muscle Rub
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)40 mg/g
METHYL SALICYLATE300 mg/g
MENTHOL100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
LAV5U5022YInternal 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
283083Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ea95529-ec4b-c2ce-e063-6394a90a0739Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-982-01Ultra Strength Muscle Rub - CVS HealthUltra Strength Muscle Rub1 in 1 CARTONCREAM12
51316-982-01Ultra Strength Muscle Rub - CVS HealthUltra Strength Muscle Rub57 g in 1 TUBECREAM572
51316-982-02Ultra Strength Muscle Rub - CVS HealthUltra Strength Muscle Rub1 in 1 CARTONCREAM12
51316-982-02Ultra Strength Muscle Rub - CVS HealthUltra Strength Muscle Rub113 g in 1 TUBECREAM1132

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 62 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC04b1d605-60aa-56f4-e063-6294a90ae7602025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC0f1406fe-3a2f-bf36-e063-6294a90a7e5e2025-11-17WarningsExact identifier
application number: M017
AY BENDITO CBDMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC30a1c6b7-e37e-32c2-e063-6394a90aa3542025-11-17WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000MENTHOL, CAMPHORWorldwide Cosmetics, Inc0816cc8f-8d0b-de27-e063-6294a90a8a9d2025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLCf6538e3e-4663-679c-e053-2995a90a87b52025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLCf65455d7-04a9-6217-e053-2995a90a7c902025-11-17WarningsExact identifier
application number: M017
JUST CBD - CBD AND THC ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLCf664eb79-8897-3a49-e053-2995a90a37b42025-11-17WarningsExact identifier
application number: M017
JUST CBD RELIEF SOOTHINGLIDOCAINE HCLJust Brands LLCf9aff6e7-5702-f61c-e053-6294a90aa66f2025-11-17WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC0abece07-976c-4881-e063-6294a90a5c1b2025-11-17WarningsExact identifier
application number: M017
Blue-Emu Thrive Pain Relief CreamTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLCa4ba6787-c99b-4bf2-9f8f-e923ef9762122025-11-14WarningsExact identifier
application number: M017
CVS Cooling PatchMENTHOLCVS Pharmacy42d97e29-f32d-a31b-e063-6394a90a88d82025-11-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
application number: M017
EXTREME EMUMENTHOL, METHYL SALICYLATERenu Laboratories, LLC4393b57b-1e70-b8dd-e063-6294a90ae7482025-11-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN2ea95529-ec4b-c2ce-e063-6394a90a07392
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD2ea95529-ec4b-c2ce-e063-6394a90a07392
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY2ea95529-ec4b-c2ce-e063-6394a90a07392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-982-01513160982011 TUBE in 1 CARTON (51316-982-01) / 57 g in 1 TUBE1 tube2025-08-15NoNoCurrent
51316-982-02513160982021 TUBE in 1 CARTON (51316-982-02) / 113 g in 1 TUBE1 tube2025-08-15NoNoCurrent