MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
68788-8895
11-digit product format
687888895
Labeler code
68788
Product ID
68788-8895_cca84334-2e2d-4991-9d1e-d5b7c9ffd392
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VW4H1CYW1KMICONAZOLE NITRATE22832-87-7MICONAZOLE NITRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8895-3687888895031 TUBE in 1 BOX (68788-8895-3) / 28.3 g in 1 TUBE1 tube2025-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rugby Miconazole Nitrate 2%Preferred Pharmaceuticals Inc.2025-08-01HUMAN OTC DRUG LABEL1