Home NDC 68599-1471 Miconazole Nitrate
Product NDC 68599-1471
11-digit product format 685991471
Labeler code 68599
Product ID 68599-1471_2424691e-9201-a1b8-e063-6294a90a1cde
Type HUMAN OTC DRUG
Nonproprietary name Antifungal
Dosage form CREAM
Route TOPICAL
Labeler McKesson
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-25
Substance MICONAZOLE NITRATE
Active strength 2 mg/100mg
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product 68599-1471 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68599-1471 68599-1471-4 Y Unknown FDA exclusion code: Y excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…
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 Miconazole Nitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 mg/100mg
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 68599-1471-4 Miconazole Nitrate 118 mg in 1 TUBE CREAM 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68599-1471 MICONAZOLE NITRATE (ANTIFUNGAL) CREAM [MCKESSON] 3 Current NDC, Legacy NDC, 1 package rows 20241012_8dcca44a-16c7-7262-e053-2a95a90a1b23.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 Marketing end Sample Exclude flag Status 68599-1471-4 68599147104 118 mg in 1 TUBE (68599-1471-4) 118 mg 2019-07-25 0000-00-00 No No Current