Home NDC 63347-810 Vite20
Product NDC 63347-810
11-digit product format 633470810
Labeler code 63347
Product ID 63347-810_27a77fc1-4426-4d60-822b-3d85a0560f13
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form LIQUID
Route TOPICAL
Labeler Blaine Labs Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-01
Substance MICONAZOLE NITRATE
Active strength .3 mg/15mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 Vite20
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE .3 mg/15mL
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 998525 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 63347-810-01 Vite20 1 in 1 BOX LIQUID 1 5 63347-810-01 Vite20 15 mL in 1 BOTTLE LIQUID 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63347-810 VITE20 (MICONAZOLE NITRATE) LIQUID [BLAINE LABS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241226_28a8d0dd-aab9-44ff-bab6-7ec4b5036a71.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 63347-810-01 63347081001 1 BOTTLE in 1 BOX (63347-810-01) / 15 mL in 1 BOTTLE 1 bottle 2016-04-01 0000-00-00 No No Current