Muscle and Joint Pain Relief

Product NDC
53943-991
11-digit product format
539430991
Labeler code
53943
Product ID
53943-991_2425da91-75ed-5f8f-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, METHYL SALICYLATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Discount Drug Mart, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-11-09
Marketing end
0000-00-00
Substance
MENTHOL; METHYL SALICYLATE
Active strength
10 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53943-991IInactivated by FDA2026-10-15
excluded packagepackage53943-99153943-991-04IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53943-991-04IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53943-991-04IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53943-991-04IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53943-991-04IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53943-991-04IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53943-991-04IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53943-991-04IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53943-991-04IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53943-991-04IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53943-991-04IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53943-991-04IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53943-991-04IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53943-991-04IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53943-991-04IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53943-991-04IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53943-991-04IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53943-991-04IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53943-991-04IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53943-991-04IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-991-04IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-991-04IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53943-991-04EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-991-042020-01-31C16284748780-19d75b9d0-26aa-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-991-04Muscle and Joint Pain Relief114 g in 1 TUBECREAM1141
53943-991-04Muscle and Joint Pain Relief1 in 1 BOXCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
PEG-15 GLYCERYL STEARATEINACTIVE INGREDIENT91245SPD5KMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-991MUSCLE AND JOINT PAIN RELIEF (MENTHOL, METHYL SALICYLATE) CREAM [DISCOUNT DRUG MART, INC.]1Legacy NDC, 2 package rows20151110_24259fe5-c725-17e0-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN24259fe5-c725-17e0-e054-00144ff88e881
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD24259fe5-c725-17e0-e054-00144ff88e881
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY24259fe5-c725-17e0-e054-00144ff88e881
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY24259fe5-c725-17e0-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53943-991-0453943099104114 g in 1 TUBE114 gHistorical