FDA.reportPublic FDA data

Muscle Rub

Product NDC
52000-020
Requested package NDC
52000-020-37
11-digit product format
520000020
Labeler code
52000
Product ID
52000-020_d882ec1c-a98e-693d-e053-2995a90a282d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-15
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage52000-02052000-020-37IInactivated by FDA2026-10-05

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 · 4 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…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-020-372025-07-29C16284748780-19d75b9d1-200a-f424-e053-dadaa90a57ceU Muscle Rub Gel
52000-020-372020-12-14C16284748780-19d75b9d1-200a-f424-e053-dadaa90a57ceU Muscle Rub Gel
52000-020-372020-01-31C16284748780-19d75b9d1-200a-f424-e053-dadaa90a57ceU Muscle Rub Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-020-37Muscle Rub1 in 1 BOXGEL14
52000-020-38Muscle Rub35 g in 1 TUBEGEL354

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3AMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
ISOCETETH-20INACTIVE INGREDIENTO020065R7ZMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-020MUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]4Legacy NDC, 2 package rows20241212_4481b268-8e92-4dab-a376-98db8b360a7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282805menthol 2.5 % Topical GelPSN4481b268-8e92-4dab-a376-98db8b360a7c4
282805menthol 0.025 MG/MG Topical GelSCD4481b268-8e92-4dab-a376-98db8b360a7c4
282805menthol 2.5 % Topical GelSY4481b268-8e92-4dab-a376-98db8b360a7c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-020-37520000020371 TUBE in 1 BOX (52000-020-37) > 35 g in 1 TUBE (52000-020-38) 1 tube2020-12-130000-00-00NoNoCurrent