Muscle Rub Ultra

Product NDC
67510-0659
Requested package NDC
67510-0659-1
11-digit product format
675100659
Labeler code
67510
Product ID
67510-0659_ab9c9238-d822-a29e-e053-2a95a90a10d1
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor,Menthol, methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-08-11
Marketing end
0000-00-00
Substance
MENTHOL; MENTHYL SALICYLATE, (+/-)-; CAMPHOR (NATURAL)
Active strength
10 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67510-065967510-0659-1IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0659-1Muscle Rub Ultra35 g in 1 TUBECREAM358
67510-0659-1Muscle Rub Ultra1 in 1 BOXCREAM18
67510-0659-2Muscle Rub Ultra1 in 1 BOXCREAM18
67510-0659-2Muscle Rub Ultra28 g in 1 TUBECREAM288

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Camphor (Natural)ACTIVE INGREDIENTN20HL7Q941MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
MentholACTIVE INGREDIENTL7T10EIP3AMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
Menthyl SalicylateACTIVE INGREDIENT43XOA705ZDMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
Camphor (Natural)ACTIVE MOIETYN20HL7Q941MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
MentholACTIVE MOIETYL7T10EIP3AMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
Menthyl SalicylateACTIVE MOIETY43XOA705ZDMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
LANOLININACTIVE INGREDIENT7EV65EAW6HMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0659MUSCLE RUB ULTRA (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [KAREWAY PRODUCT, INC.]8Legacy NDC, 4 package rows20230219_4ed30556-a6f0-4c23-895b-bdf5e25f06e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN4ed30556-a6f0-4c23-895b-bdf5e25f06e28
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD4ed30556-a6f0-4c23-895b-bdf5e25f06e28
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY4ed30556-a6f0-4c23-895b-bdf5e25f06e28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0659-1675100659011 TUBE in 1 BOX (67510-0659-1) > 35 g in 1 TUBE1 tube2011-08-110000-00-00NoNoCurrent