FDA.reportPublic FDA data

Muscle Rub

Product NDC
0536-1349
11-digit product format
005361349
Labeler code
0536
Product ID
0536-1349_5b8772e1-bb32-688e-e063-6294a90ab112
Type
HUMAN OTC DRUG
Nonproprietary name
menthol and methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-28
Substance
MENTHOL; METHYL SALICYLATE
Active strength
100; 150 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
Muscle Rub
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL100 mg/g
METHYL SALICYLATE150 mg/g

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
0536-1349-57Rugby Muscle Rub Cream1 in 1 CARTONCREAM12
0536-1349-57Rugby Muscle Rub Cream85 g in 1 TUBECREAM852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1349-57GM - Gram0536-13499181542a-8000-4546-8eaf-51ea8eab395912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1349RUGBY MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [RUGBY LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20241114_7c6f49d9-0ecd-494a-abd3-cdda6d6e5d06.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 44 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN7c6f49d9-0ecd-494a-abd3-cdda6d6e5d062
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSNea209a4e-acad-413b-8fb9-27e98130bcd62
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD7c6f49d9-0ecd-494a-abd3-cdda6d6e5d062
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDea209a4e-acad-413b-8fb9-27e98130bcd62
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY7c6f49d9-0ecd-494a-abd3-cdda6d6e5d062
311498menthol 10 % / methyl salicylate 15 % Topical CreamSYea209a4e-acad-413b-8fb9-27e98130bcd62
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY7c6f49d9-0ecd-494a-abd3-cdda6d6e5d062
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSYea209a4e-acad-413b-8fb9-27e98130bcd62
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN2d58c15a-5ddb-1b16-e063-6294a90a3fbb1
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD2d58c15a-5ddb-1b16-e063-6294a90a3fbb1
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY2d58c15a-5ddb-1b16-e063-6294a90a3fbb1
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY2d58c15a-5ddb-1b16-e063-6294a90a3fbb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1349-57005361349571 TUBE in 1 CARTON (0536-1349-57) / 85 g in 1 TUBE1 tube2022-02-280000-00-00NoNoCurrent