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 17 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact 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