Home NDC 68016-291 Miconazole
Product NDC 68016-291
11-digit product format 680160291
Labeler code 68016
Product ID 68016-291_421e11c4-085b-4f3d-bbbc-079d4ea522fc
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Chain Drug Consortium, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-05-15
Marketing end 2026-12-31
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Miconazole Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-291-01 Miconazole 1 in 1 CARTON CREAM 1 12 68016-291-01 Miconazole 28 g in 1 TUBE CREAM 28 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MICONAZOLE NITRATE ACTIVE INGREDIENT VW4H1CYW1K MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 MICONAZOLE ACTIVE MOIETY 7NNO0D7S5M MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 PEG-5 OLEATE INACTIVE INGREDIENT 0240V77G50 MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 PEGOXOL 7 STEARATE INACTIVE INGREDIENT 3EW5AXE5X5 MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-291 MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20231007_246be926-79ea-4e0c-a3ef-2aa7fc3a52bf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-291-01 68016029101 1 TUBE in 1 CARTON (68016-291-01) / 28 g in 1 TUBE 1 tube 2009-05-15 2026-12-31 No No Current