FDA.reportPublic FDA data

Medicated Athletes Foot Powder

Product NDC
56104-906
11-digit product format
561040906
Labeler code
56104
Product ID
56104-906_5023cd64-50ab-d54b-e063-6294a90a08f2
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-24
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Medicated Athletes Foot PowderMICONAZOLE NITRATEPremier Brands of America Inc.38cc0c66-82b5-bac4-e063-6294a90a23f02026-04-23WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes Stop and ask a doctor if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch. 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
Medicated Athletes Foot Powder
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998461

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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-906-01Medicated Athletes Foot Powder99 g in 1 BOTTLE, PLASTICPOWDER993
56104-906-02Medicated Athletes Foot Powder127 g in 1 BOTTLE, PLASTICPOWDER1273

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN38cc0c66-82b5-bac4-e063-6294a90a23f03
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD38cc0c66-82b5-bac4-e063-6294a90a23f03
998461miconazole nitrate 2 % Topical PowderSY38cc0c66-82b5-bac4-e063-6294a90a23f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56104-906-015610409060199 g in 1 BOTTLE, PLASTIC (56104-906-01) 99 g2025-06-26NoNoCurrent
56104-906-0256104090602127 g in 1 BOTTLE, PLASTIC (56104-906-02) 127 g2025-06-24NoNoCurrent