MICONAZOLE Nitrate 2%

Product NDC
71399-0071
11-digit product format
713990071
Labeler code
71399
Product ID
71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dca
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-19
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%
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
71399-0071-1MICONAZOLE Nitrate 2%1 in 1 BOXCREAM12
71399-0071-1MICONAZOLE Nitrate 2%14.2 g in 1 TUBECREAM14.22
71399-0071-3MICONAZOLE Nitrate 2%28.4 g in 1 TUBECREAM28.42
71399-0071-3MICONAZOLE Nitrate 2%1 in 1 BOXCREAM12
71399-0071-4MICONAZOLE Nitrate 2%42.5 g in 1 TUBECREAM42.52
71399-0071-4MICONAZOLE Nitrate 2%1 in 1 BOXCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0071-1GM - Gram71399-00711814945a-3df2-46fa-bf9c-cbf86c6023e212025-01-14
71399-0071-3GM - Gram71399-007162478811-bd3d-44d6-85d5-4aa695061e7312025-01-14
71399-0071-4GM - Gram71399-00719d8f2a9f-65b3-4c93-ba71-0fca2ff1be8a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0071MICONAZOLE NITRATE 2% (MICONAZOLE NITRATE) CREAM [AKRON PHARMA INC.]2Current NDC, 6 package rows20250120_8933f939-098a-4257-8d9c-4d5c3240e9a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN8933f939-098a-4257-8d9c-4d5c3240e9a62
998483miconazole nitrate 20 MG/ML Topical CreamSCD8933f939-098a-4257-8d9c-4d5c3240e9a62
998483miconazole nitrate 2 % Topical CreamSY8933f939-098a-4257-8d9c-4d5c3240e9a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0071-1713990071011 TUBE in 1 BOX (71399-0071-1) / 14.2 g in 1 TUBE1 tube2024-11-19NoNoHistorical
71399-0071-3713990071031 TUBE in 1 BOX (71399-0071-3) / 28.4 g in 1 TUBE1 tube2024-11-19NoNoHistorical
71399-0071-4713990071041 TUBE in 1 BOX (71399-0071-4) / 42.5 g in 1 TUBE1 tube2024-11-19NoNoHistorical