Home NDC 67777-710 Antifungal
Product NDC 67777-710
11-digit product format 677770710
Labeler code 67777
Product ID 67777-710_4d384385-f3c6-09ba-e063-6394a90aec7f
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Dynarex Corporation
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-24
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 Antifungal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100g
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# 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 36 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 Sample Exclude flag Status 67777-710-01 67777071001 5 g in 1 PACKET 5 g Historical 67777-710-02 67777071002 2 BOX in 1 CASE (67777-710-02) / 144 PACKET in 1 BOX (67777-710-01) / 5 g in 1 PACKET 2 box 2026-03-24 No No Current 67777-710-03 67777071003 113 g in 1 TUBE 113 g Historical 67777-710-04 67777071004 6 in 1 BOX Historical 67777-710-05 67777071005 4 BOX in 1 CASE (67777-710-05) / 6 TUBE in 1 BOX (67777-710-04) / 113 g in 1 TUBE (67777-710-03) 4 box 2026-03-24 No No Current