FDA.reportPublic FDA data

MyoRx

Product NDC
59088-962
Requested package NDC
59088-962-05
11-digit product format
590880962
Labeler code
59088
Product ID
59088-962_f2054cd2-8391-7f92-e053-2995a90a9acc
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-01-28
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage59088-96259088-962-05DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59088-96259088-962-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59088-96259088-962-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
MENTHOLACTIVE MOIETYL7T10EIP3AMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8MYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
BORAGE OILINACTIVE INGREDIENTF8XAG1755SMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
CAPSAICININACTIVE INGREDIENTS07O44R1ZMMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662MYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGGMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
HYDROGENATED MENHADEN OILINACTIVE INGREDIENT736VD7888JMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
SQUALANEINACTIVE INGREDIENTGW89575KF9MYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RMYORX PAIN RELIEVING (MENTHOL) CREAM [PURETEK CORPORATION]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-962-055908809620559 mL in 1 JAR (59088-962-05) 59 ml2010-01-280000-00-00NoNoCurrent