MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
69771-041
11-digit product format
697710041
Labeler code
69771
Product ID
69771-041_334ee902-e3c8-59f1-e063-6294a90adee6
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
GERI-GENTLE CORPORATION
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-041-252025-04-21C16284748780-11030e365-30f7-111a-e063-dadaa90a10e2MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
69771-041-252024-01-30C16284748780-11030e365-30f7-111a-e063-dadaa90a10e2MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-041-25MICONAZOLE Nitrate 2% Cream ANTIFUNGAL113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-041MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GERI-GENTLE CORPORATION]2Current NDC, Legacy NDC, 1 package rows20250423_e6734616-c16b-430c-e053-2a95a90a18f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNe6734616-c16b-430c-e053-2a95a90a18f82
998483miconazole nitrate 20 MG/ML Topical CreamSCDe6734616-c16b-430c-e053-2a95a90a18f82
998483miconazole nitrate 2 % Topical CreamSYe6734616-c16b-430c-e053-2a95a90a18f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69771-041-2569771004125113 g in 1 TUBE (69771-041-25) 113 g2022-08-160000-00-00NoNoCurrent