Home NDC 55681-047 ProCure Antifungal
Product NDC 55681-047
11-digit product format 556810047
Labeler code 55681
Product ID 55681-047_49758be2-d2d5-d4ad-e063-6294a90a9b03
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate 2%
Dosage form CREAM
Route TOPICAL
Labeler Twin Med LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
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 ProCure 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55681-047-04 ProCure Antifungal 106 g in 1 TUBE CREAM 106 2 55681-047-05 ProCure Antifungal 5 g in 1 PACKET CREAM 5 2 55681-047-14 ProCure Antifungal 144 in 1 CARTON CREAM 144 2
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 40 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 55681-047-04 55681004704 106 g in 1 TUBE (55681-047-04) 106 g 2025-12-01 No No Current 55681-047-05 55681004705 5 g in 1 PACKET 5 g Historical 55681-047-14 55681004714 144 PACKET in 1 CARTON (55681-047-14) / 5 g in 1 PACKET (55681-047-05) 144 packet 2026-10-01 No No Current