Antifungal Cream

Product NDC
21922-095
11-digit product format
219220095
Labeler code
21922
Product ID
21922-095_7d6e5fac-1b6c-49df-8a84-7702c4821c31
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
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
Antifungal Cream
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-095-06Antifungal Cream1 in 1 CARTONCREAM12
21922-095-06Antifungal Cream42.5 g in 1 TUBECREAM42.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-095-06GM - Gram21922-095f3534f4e-74fd-4d85-8423-03228d3520c712025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-095ANTIFUNGAL CREAM (MICONAZOLE NITRATE) CREAM [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 2 package rows20250424_8be4bbfa-424c-4ccf-b8bc-65b16c126053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN8be4bbfa-424c-4ccf-b8bc-65b16c1260532
998483miconazole nitrate 20 MG/ML Topical CreamSCD8be4bbfa-424c-4ccf-b8bc-65b16c1260532
998483miconazole nitrate 2 % Topical CreamSY8be4bbfa-424c-4ccf-b8bc-65b16c1260532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-095-06219220095061 TUBE in 1 CARTON (21922-095-06) / 42.5 g in 1 TUBE1 tube2025-03-06NoNoCurrent