FDA.reportPublic FDA data

Menthol

Product NDC
36800-252
11-digit product format
368000252
Labeler code
36800
Product ID
36800-252_5ccea69a-bfc7-4068-e063-6394a90a177b
Type
HUMAN OTC DRUG
Nonproprietary name
Maximum Strength Medicated Foot Powder Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-10
Substance
MENTHOL
Active strength
2.8 g/283g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct36800-252IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage36800-25236800-252-10IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Menthol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.8 g/283g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-01-27Top Care Menthol Foot Powder Talc Free
2023-01-27Top Care Menthol Foot Powder Talc Free
2023-01-27Top Care Menthol Foot Powder Talc Free
2022-07-29Top Care Menthol Foot Powder Talc Free
2022-07-29Top Care Menthol Foot Powder Talc Free
2022-07-29Top Care Menthol Foot Powder Talc Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-252-10Menthol283 g in 1 BOTTLE, PLASTICPOWDER2837

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-252MENTHOL (MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE) POWDER [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 1 package rows20241213_7caef8db-a07a-6705-e053-2991aa0aa724.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 121 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLCdc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab2024-11-05WarningsExact identifier
application number: M017
Aveeno Restorative Skin Therapy Itch Relief BalmPRAMOXINE HYDROCHLORIDEKenvue Brands LLC61824ca7-a2d3-4830-b2bb-149a3222bfc82024-11-05WarningsExact identifier
application number: M017
Aveeno Hydrocortisone ANTI-ITCHHYDROCORTISONEKenvue Brands LLC233de4d7-e533-40cd-a5ed-e8b09abc626e2024-11-05WarningsExact identifier
application number: M017
STING MASTERLIDOCAINE HYDROCHLORIDELes Technologies Ptero, Inc94c6fd1f-9e74-420b-9d25-61b37953b8382024-11-05WarningsExact identifier
application number: M017
Alocane Emergency BurnLIDOCAINE HYDROCHLORIDEQuest Products, LLC.0c8e65a6-dff3-43b4-a3f1-95deb574ea892024-11-05WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
application number: M017
Alocane BotanicalsLIDOCAINE HYDROCHLORIDEQuest Products, LLC.02a8e5c7-56f4-eb0d-e063-6294a90a80cd2024-11-05WarningsExact identifier
application number: M017
Alocane Emergency Burn PadsLIDOCAINE HYDROCHLORIDEQuest Products, Inc.fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
application number: M017
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
application number: M017
TopCare Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDETopco Associates LLC6b4783e0-1987-4838-9e8c-b95426d62b282024-11-05WarningsExact identifier
application number: M017
Eagle Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEBorden Company (Private) Limiteded79f14e-6b3d-4bf2-9c34-d019c1ba25822024-11-04WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEA-S Medication Solutions3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e32024-11-04WarningsExact identifier
application number: M017
Walgreens Ice Blue Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMWalgreen Company1c0ee442-ffd2-4f6c-aab2-f70e295378ad2024-11-04WarningsExact identifier
application number: M017
Walgreen Cool n Heat Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORMWalgreen Companyd5c79476-dde8-4a85-8878-bc2ac3a3d70b2024-11-04WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINESTRATUS PHARMACEUTICALS INC87a4f559-a4f6-4b9f-98de-b55b073a11c62024-11-01WarningsExact identifier
application number: M017
Walgreens Nerve Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMWalgreen Company83849eca-e02f-4b43-b3a7-b25e987e08a82024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica WhiteCAMPHORSanvall Enterprises, Inc192039a2-aed6-821b-e063-6394a90a7f292024-10-31WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259579menthol 1 % Topical PowderPSN7caef8db-a07a-6705-e053-2991aa0aa7247
259579menthol 0.01 MG/MG Topical PowderSCD7caef8db-a07a-6705-e053-2991aa0aa7247
259579menthol 1 % Topical PowderSY7caef8db-a07a-6705-e053-2991aa0aa7247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-252-1036800025210283 g in 1 BOTTLE, PLASTIC (36800-252-10) 283 g2019-02-100000-00-00NoNoCurrent