Miconazole nitrate

Product NDC
56104-903
11-digit product format
561040903
Labeler code
56104
Product ID
56104-903_42b88029-f079-6b9e-e063-6294a90a8342
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal Miconazole Liquid Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-18
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
Miconazole nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998533

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
56104-903-01Miconazole nitrate150 g in 1 CANAEROSOL, SPRAY1503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998533miconazole nitrate 2 % Topical SprayPSN3803c643-35d1-06d4-e063-6294a90ac6f63
998533miconazole nitrate 20 MG/ML Topical SpraySCD3803c643-35d1-06d4-e063-6294a90ac6f63
998533miconazole nitrate 2 % Topical SpraySY3803c643-35d1-06d4-e063-6294a90ac6f63
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY3803c643-35d1-06d4-e063-6294a90ac6f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56104-903-0156104090301150 g in 1 CAN (56104-903-01) 150 g2025-06-18NoNoCurrent