Home NDC 87525-004 FifthPulse Miconazole Nitrate Antifungal
Product NDC 87525-004
11-digit product format 875250004
Labeler code 87525
Product ID 87525-004_4e7d2ee6-0c87-7391-e063-6394a90a4ee8
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form OINTMENT
Route TOPICAL
Labeler WeCare Products LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-30
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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 FifthPulse Miconazole Nitrate Antifungal
Listing expiration 2027-12-31 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 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 87525-004-01 FifthPulse Miconazole Nitrate Antifungal 1 in 1 BOX OINTMENT 1 1 87525-004-01 FifthPulse Miconazole Nitrate Antifungal 28.4 g in 1 TUBE OINTMENT 28.4 1 87525-004-02 FifthPulse Miconazole Nitrate Antifungal 1 in 1 BOX OINTMENT 1 1 87525-004-02 FifthPulse Miconazole Nitrate Antifungal 113.4 g in 1 TUBE OINTMENT 113.4 1
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 23 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87525-004-01 87525000401 1 TUBE in 1 BOX (87525-004-01) / 28.4 g in 1 TUBE 1 tube 2026-04-30 No No Current 87525-004-02 87525000402 1 TUBE in 1 BOX (87525-004-02) / 113.4 g in 1 TUBE 1 tube 2026-04-30 No No Current