MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
70000-0718
11-digit product format
700000718
Labeler code
70000
Product ID
70000-0718_3504ed0b-c60f-7b38-e063-6294a90ad91d
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Cardinal Health 110 dba LEADER
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-12
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
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 2% Cream ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

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
70000-0718-1MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM12
70000-0718-1MICONAZOLE Nitrate 2% Cream ANTIFUNGAL28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0718MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH 110 DBA LEADER]2Current NDC, 2 package rows20250515_34f4c733-2eb2-0db0-e063-6394a90a6431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN34f4c733-2eb2-0db0-e063-6394a90a64312
998483miconazole nitrate 20 MG/ML Topical CreamSCD34f4c733-2eb2-0db0-e063-6394a90a64312
998483miconazole nitrate 2 % Topical CreamSY34f4c733-2eb2-0db0-e063-6394a90a64312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0718-1700000718011 TUBE in 1 BOX (70000-0718-1) / 28 g in 1 TUBE1 tube2025-05-12NoNoCurrent