FDA.reportPublic FDA data

Muscle Rub

Product NDC
45802-174
Requested package NDC
45802-174-53
11-digit product format
458020174
Labeler code
45802
Product ID
45802-174_04ef342d-042e-42c9-a400-0ad2549a3e72
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-03-03
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
10 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage45802-17445802-174-53DDiscontinued by firm2026-08-07

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-174-53Varophen85 g in 1 TUBECREAM85 g15 g in 100g5
45802-174-53Varophen1 in 1 CARTONCREAM10 g in 100g5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-174-53GM - Gram45802-174fbd45582-802b-485a-a7f5-88e7055fe67212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
MENTHOLACTIVE MOIETYL7T10EIP3AMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
LANOLININACTIVE INGREDIENT7EV65EAW6HMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-174VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]5Legacy NDC20250101_1bef5035-70ad-4f75-80c3-6252cd01fa85.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VarophenDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLC1bef5035-70ad-4f75-80c3-6252cd01fa852024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 45802-174-53
ndc11 (package): 45802017453

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1bef5035-70ad-4f75-80c3-6252cd01fa855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-174-53458020174531 TUBE in 1 CARTON (45802-174-53) > 85 g in 1 TUBE1 tube2011-03-030000-00-00NoNoCurrent