Home NDC 16864-040 Triple Antifungal
Product NDC 16864-040
11-digit product format 168640040
Labeler code 16864
Product ID 16864-040_4d63f2a2-f113-d739-e063-6394a90a2d27
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form OINTMENT
Route TOPICAL
Labeler Advantice Health, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-01
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 Triple 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998442 Internal RxNorm lookup 998460 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 16864-040-02 Triple Antifungal 1 in 1 CARTON OINTMENT 1 4 16864-040-02 Triple Antifungal 56.7 g in 1 TUBE OINTMENT 56.7 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16864-040 TRIPLE ANTIFUNGAL (MICONAZOLE NITRATE) OINTMENT [ADVANTICE HEALTH, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241215_9a47fb1b-a41f-4c8a-8e43-7332853c308e.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 36 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 16864-040-02 16864004002 1 TUBE in 1 CARTON (16864-040-02) / 56.7 g in 1 TUBE 1 tube 2021-09-01 0000-00-00 No No Current