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 41 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreens2112067c-0fbb-400c-9923-b932946e1a122026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreensa7db0a6f-ceca-4e77-bad7-55c3c74413a72026-01-14WarningsExact identifier
application number: M017
CVS Therapeutic Menthol GelMENTHOLCVS Pharmacya02605cd-40d1-4ea1-9828-0695f2d123aa2026-01-14WarningsExact identifier
application number: M017
Maximum Strength CortisoneHYDROCORTISONE OINTMENTCVS Pharmacyf25f2e14-4fc9-4c92-880d-e5f9279d4ecd2026-01-14WarningsExact identifier
application number: M017
Icy Hot with Lidocaine No-MessMENTHOL AND LIDOCAINEChattem, Inc.a2803c07-bf39-4028-9262-5082da25b46e2026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Intensive Moisture CremeHYDROCORTISONEChattem, Inc.096a9af3-7e7c-4dae-bc22-44061c60d3c92026-01-14WarningsExact identifier
application number: M017
Icy Hot DryMENTHOLChattem, Inc.720a85cc-8e98-43f2-9cc8-5636ae09624f2026-01-14WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLChattem, Inc.98ea15e6-972f-44a3-a1e4-abeae538d5a72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Fragrant Ginger PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Brancha0308e0e-1b47-42ab-88ac-b71ff3fa6c472026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Easy ReliefHYDROCORTISONEChattem, Inc.beb73818-cd88-44ff-8ecd-b02b910b53b72026-01-14WarningsExact identifier
application number: M017
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Cool Herbal PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Branch3b260be8-5e2a-4fba-85d6-2e6c64b970762026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Feminine Itch ReliefHYDROCORTISONEChattem, Inc.c0c0c1fb-43c9-4903-bb3b-f0885619b8cc2026-01-14WarningsExact identifier
application number: M017
Icy Hot Pro Pain Relief Cream w/ microbeadsMENTHOL, CAMPHORChattem, Inc.df5fd485-f583-46b7-a869-16ca2e17185c2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing CremeHYDROCORTISONEChattem, Inc.4b62615f-e713-42f2-8b9c-9eebf8d1b2702026-01-14WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEChattem, Inc.5767362c-83af-494e-a815-a13f2cb093ef2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Overnight CremeHYDROCORTISONEChattem, Inc.ef2eda7e-d6a8-47e3-9d80-6074af6773dc2026-01-14WarningsExact 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