FDA.reportPublic FDA data

Menthol

Product NDC
63941-558
11-digit product format
639410558
Labeler code
63941
Product ID
63941-558_445c7a07-4f2a-f717-e063-6394a90ac462
Type
HUMAN OTC DRUG
Nonproprietary name
Maximum Strength Medicated Foot Powder
Dosage form
POWDER
Route
TOPICAL
Labeler
VALU MERCHANDISERS, CO
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-15
Marketing end
2027-04-30
Substance
MENTHOL
Active strength
2.8 g/283g
NDC exclude flag
No
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

​Warnings ​For external use only. When using this product avoid contact with the eyes Stop use and ask a doctor if conditions worsens symptoms persists for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Menthol

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui259579

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63941-558-102024-02-20C16284748780-1f386c649-c1b1-0266-e053-dadaa90a7c1aMedicated Foot Powder -Talc Free
63941-558-102024-02-20C16284748780-1f386c649-c1b1-0266-e053-dadaa90a7c1aMedicated Foot Powder -Talc Free
63941-558-102023-01-30C16284748780-1f386c649-c1b1-0266-e053-dadaa90a7c1aMedicated Foot Powder -Talc Free
63941-558-102023-01-30C16284748780-1f386c649-c1b1-0266-e053-dadaa90a7c1aMedicated Foot Powder -Talc Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-558-10Menthol283 g in 1 BOTTLE, PLASTICPOWDER2838

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-558MENTHOL (MAXIMUM STRENGTH MEDICATED FOOT POWDER) POWDER [VALU MERCHANDISERS, CO]6Current NDC, Legacy NDC, 1 package rows20241109_89a5c4bb-442f-d3f0-e053-2a95a90a51bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259579menthol 1 % Topical PowderPSN89a5c4bb-442f-d3f0-e053-2a95a90a51bd8
259579menthol 0.01 MG/MG Topical PowderSCD89a5c4bb-442f-d3f0-e053-2a95a90a51bd8
259579menthol 1 % Topical PowderSY89a5c4bb-442f-d3f0-e053-2a95a90a51bd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-558-1063941055810283 g in 1 BOTTLE, PLASTIC (63941-558-10) 283 g2019-07-152027-04-30NoNoCurrent