Antifungal

Product NDC
80513-771
11-digit product format
805130771
Labeler code
80513
Product ID
80513-771_3af71de6-43f9-b1a2-e063-6394a90a5050
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Advanced Rx LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antifungal
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-771-03Antifungal85 g in 1 BOTTLEPOWDER851

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNe13eb653-3916-444a-ae86-1738c0308b791
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDe13eb653-3916-444a-ae86-1738c0308b791
998461miconazole nitrate 2 % Topical PowderSYe13eb653-3916-444a-ae86-1738c0308b791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80513-771-038051307710385 g in 1 BOTTLE (80513-771-03) 85 g2025-01-01NoNoCurrent