FDA.reportPublic FDA data

CVS Muscle Balm and Roll-On

Product NDC
51316-241
11-digit product format
513160241
Labeler code
51316
Product ID
51316-241_4e40025a-070b-508e-e063-6394a90af5d7
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
KIT
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-13
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
CVS Muscle Balm and Roll-On
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1089847Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e40025a-070a-508e-e063-6394a90af5d7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-241-01CVS Muscle Balm and Roll-On1 in 1 CARTONKIT11
51316-243-63CVS Muscle Balm and Roll-On18 g in 1 JAROINTMENT18 g110 mg in 1g1
51316-244-25CVS Muscle Balm and Roll-On74 mL in 1 BOTTLE, WITH APPLICATORGEL74 mL110 mg in 1mL1

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 44 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HCILIDOCAINE HCITrifluent Pharma, LLC47f7f06b-720e-eeec-e063-6294a90ae8232026-01-09WarningsExact identifier
application number: M017
LidocaineLIDOCAINEBellus Medical, LLC60cb89f6-e326-0773-e053-2a91aa0a33dd2026-01-09WarningsExact identifier
application number: M017
TetracaineTETRACAINEBellus Medical, LLC60cabb5f-606b-7a74-e053-2a91aa0ac0242026-01-09WarningsExact identifier
application number: M017
BenzocaineBENZOCAINEBellus Medical, LLC60cafbaf-8ec6-46a5-e053-2a91aa0af11f2026-01-09WarningsExact identifier
application number: M017
PRAXPRAMOXINE HYDROCHLORIDEAvPAKdc646399-91ba-5cc1-e053-2a95a90a4f9c2026-01-09WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
application number: M017
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
application number: M017
LIDOCAINE PAIN RELIEVING Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2159fb73-cf6c-184a-e063-6394a90a1d142026-01-08WarningsExact identifier
application number: M017
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0ca84-2800-d222-e053-2995a90ad8f32026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5b0db6-8f0a-4f8e-e053-2995a90a22b72026-01-08WarningsExact identifier
application number: M017
Capsaicin Topical AnalgesicCAPSAICINAvPAKef597423-cd01-7324-e053-2a95a90aa1ba2026-01-08WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINAvPAKef5a3846-1d2f-7023-e053-2a95a90ad7162026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5bb0fa-afc2-62d7-e053-2a95a90a37f42026-01-08WarningsExact identifier
application number: M017
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
application number: M017
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
application number: M017
Relieve A PainLIDOCAINERelieve A Pain LLCcafaa830-d894-4590-8928-d579cc791d792026-01-08WarningsExact identifier
application number: M017
DZUL ARTHRITIS PAIN RELIEFMENTHOLCaball Sales, Inc.159c301c-d462-bb2c-e063-6394a90a9e5a2026-01-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1089847camphor 11 % / menthol 11 % Topical OintmentPSN4e40025a-070a-508e-e063-6394a90af5d71
1089847camphor 0.11 MG/MG / menthol 0.11 MG/MG Topical OintmentSCD4e40025a-070a-508e-e063-6394a90af5d71
1089847camphor 11 % / menthol 11 % Topical OintmentSY4e40025a-070a-508e-e063-6394a90af5d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-241-01513160241011 KIT in 1 CARTON (51316-241-01) * 74 mL in 1 BOTTLE, WITH APPLICATOR (51316-244-25) * 18 g in 1 JAR (51316-243-63) 1 kit2026-04-13NoNoCurrent
51316-243-635131602436318 g in 1 JAR18 gHistorical
51316-244-255131602442574 mL in 1 BOTTLE, WITH APPLICATOR74 mlHistorical