Home NDC 85384-0004 Folliculitis Treatment Cream
Product NDC 85384-0004
11-digit product format 853840004
Labeler code 85384
Product ID 85384-0004_df9c4cbf-0be3-46db-9e66-40c6a2b5f0c1
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler TAGRID LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-22
Substance MICONAZOLE NITRATE
Active strength 15 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 Folliculitis Treatment Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 15 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 2712237 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 85384-0004-1 Folliculitis Treatment Cream 100 g in 1 BOTTLE, PLASTIC CREAM 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85384-0004 FOLLICULITIS TREATMENT CREAM (MICONAZOLE NITRATE) CREAM [TAGRID LLC] 1 Current NDC, 1 package rows 20250423_32396be0-f74a-5483-e063-6294a90ab3ae.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 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 85384-0004-1 85384000401 100 g in 1 BOTTLE, PLASTIC (85384-0004-1) 100 g 2025-04-22 No No Current 85384-0004-2 85384000402 100 g in 1 JAR (85384-0004-2) 100 g 2025-04-22 No No Current