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 23 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kevo-ProphenJUNIPER TARFaeve, LLC4fe773a8-77cd-831e-e063-6294a90ae2ca2026-04-20WarningsExact identifier
application number: M017
BeeVenomMETHYL SALICYLATEMenper Distributors, Inc.4fe7a986-336d-ad4e-e063-6294a90a0b8a2026-04-20WarningsExact identifier
application number: M017
BenzodentBENZOCAINEFocus Consumer Healthcare, LLC5fdcb871-d387-6352-e053-2991aa0a09da2026-04-20WarningsExact identifier
application number: M017
Tecnu CalagelDIPHENHYDRAMINE HYDROCHLORIDETec Laboratories Inc.8bc9cbfe-1dd4-18ed-e053-2a95a90a79662026-04-20WarningsExact identifier
application number: M017
Aemerry Numbing CreamMENTHOL 5%Da Capo Prima LLC4fefddaf-19c8-86b4-e063-6294a90abffc2026-04-20WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4fc7a356-2f1d-85af-e063-6394a90aec6b2026-04-18WarningsExact identifier
application number: M017
Equate Lidocaine and Menthol Paraben FreeLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Inc4fa917de-bc46-0b8d-e063-6294a90a218a2026-04-17WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC4faa515f-6040-d948-e063-6294a90a187f2026-04-17WarningsExact identifier
application number: M017
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLUniversal Distribution Center LLC4f921ced-7722-cba5-e063-6294a90a650b2026-04-16WarningsExact identifier
application number: M017
Walgreens Capsaicin Hot PatchCAPSAICINWalgreen Co.41e959d8-f6ac-f5b4-e063-6294a90abd962026-04-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relieving PatchMENTHOLWalgreen Co.41e7574a-348f-8eb8-e063-6294a90a6e902026-04-16WarningsExact identifier
application number: M017
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
application number: M017
Kroger Witch HazelWITCH HAZELKroger Co.461407d0-fbf6-47e9-e063-6394a90a9a832026-04-16WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.86fe4e8c-5279-445a-a19a-e694eac785fd2026-04-16WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.4503208f-2808-4727-8066-c431230bd70b2026-04-16WarningsExact identifier
application number: M017
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ONMENTHOLTROY MANUFACTURING, INC895896dc-0762-40a7-8313-cca10ce689842026-04-16WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5%MENTHOLVeridian Healthcare4f9b1b2d-1acc-e0a7-e063-6394a90aadbc2026-04-16WarningsExact identifier
application number: M017
Lidoease 2%LIDOCAINE HCL 2%PureTek Corporation3ba0c0ff-0f7a-7a29-e063-6294a90a547a2026-04-16WarningsExact identifier
application number: M017
Walgreens Lidocaine Pain Relieving Patch AssortedLIDOCAINEWalgreen Co.41e98f15-669f-4543-e063-6294a90a1ef72026-04-15WarningsExact 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