Home NDC 52000-021 Anti-Fungal
Product NDC 52000-021
11-digit product format 520000021
Labeler code 52000
Product ID 52000-021_18f39e0a-6734-31b9-e063-6294a90a7204
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Universal Distribution Center LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-04-15
Substance MICONAZOLE NITRATE
Active strength .02 g/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 52000-021-37 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 52000-021-37 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 52000-021-37 9bebd1f3094a…5416666fcb17…
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 Anti-Fungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE .02 g/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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52000-021-40 Anti-Fungal 14 g in 1 TUBE CREAM 14 6 52000-021-41 Anti-Fungal 1 in 1 BOX CREAM 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52000-021 ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240522_8f316b0d-d308-4ae6-82c4-39bb0d1d474e.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 52000-021-37 52000002137 1 TUBE in 1 BOX (52000-021-37) > 14 g in 1 TUBE (52000-021-36) 1 tube 2022-02-14 0000-00-00 No No Current 52000-021-40 52000002140 14 g in 1 TUBE 14 g Historical 52000-021-41 52000002141 1 TUBE in 1 BOX (52000-021-41) / 14 g in 1 TUBE (52000-021-40) 1 tube 2022-02-14 No No Current