FDA.reportPublic FDA data

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
IngredientStrength
MICONAZOLE NITRATE.3 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998525Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28a8d0dd-aab9-44ff-bab6-7ec4b5036a71Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-810-012022-02-21C16284748780-1d6a99b39-5041-a426-e053-dadaa90af4c2Vite20 - 810
63347-810-012022-01-28C16284748780-1d6a99b39-5041-a426-e053-dadaa90af4c2Vite20 - 810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-810-01Vite201 in 1 BOXLIQUID15
63347-810-01Vite2015 mL in 1 BOTTLELIQUID155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-810VITE20 (MICONAZOLE NITRATE) LIQUID [BLAINE LABS INC.]5Current NDC, Legacy NDC, 2 package rows20241226_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 9 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIobow FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a49db2b-e45a-57c5-e063-6294a90a065c2026-06-23WarningsExact identifier
application number: M005
RoyceDerm Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC54d3ae29-8919-4868-e063-6294a90a587e2026-06-22WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT LIQUIDWalgreens Company94f4f656-e8a3-4439-b53c-12be59dc8eac2026-06-20WarningsExact identifier
application number: M005
VTROUY Fungal Nail Renewal PenFUNGAL NAIL RENEWAL PENGuangzhou Jingliang Cosmetics Co., Ltd.549bf490-99c2-c800-e063-6394a90a672b2026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreeTOLNAFTATERida LLC0c7a3b2d-8b1c-4130-86ad-892a591574802026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsExact identifier
application number: M005
Anytalk FUNGAL NAIL TREATMENTTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.54718558-376f-ed31-e063-6294a90a52202026-06-17WarningsExact identifier
application number: M005
KLIPP FUNGAL NAIL TREATMENTKLIPP FUNGAL NAIL TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f2fbe-a2de-057d-e063-6394a90ac7422026-06-17WarningsExact identifier
application number: M005
GeriGentle Miconazole nitrateANTIFUNGALGERI-GENTLE CORPORATION0ae03b4a-06c8-ddf9-e063-6294a90ad1052026-06-16WarningsExact identifier
application number: M005
WKPIKI FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.54472c44-93de-d4b9-e063-6394a90adde12026-06-15WarningsExact identifier
application number: M005
BIOSHUGA Dermomucosal Antibacterial GelBIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GELGuangxi Rise Biological Technology Co.,Ltd.5456574a-dda4-9c67-e063-6294a90ac2222026-06-15WarningsExact identifier
application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SolutionBIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTIONGuangxi Rise Biological Technology Co.,Ltd.5457a623-7812-e516-e063-6394a90a8bfd2026-06-15WarningsExact identifier
application number: M005
TOYKNIER MULTI-PURPOSE TREATMENTUNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4f8eb3a3-8f26-50dd-e063-6294a90ad9f82026-06-14WarningsExact identifier
application number: M005
CYYZROSE ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD527765d4-6988-ed4e-e063-6394a90a2f232026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a2317d2-e45b-1fe2-e063-6394a90a940d2026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a23c01b-492d-324b-e063-6394a90a73b12026-06-14WarningsExact identifier
application number: M005
HEALMUSZ Multi-PurposeTreatmentTOLNAFTATE 1% MULTI-PURPOSETREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a2421d8-a543-abb1-e063-6394a90afaa72026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a24b5ae-f86c-459f-e063-6394a90ac5c32026-06-14WarningsExact identifier
application number: M005
PUVIDA Helps WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4828d7-091b-7c8e-e063-6294a90af1362026-06-14WarningsExact identifier
application number: M005
PUVIDA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4a484e3d-d653-2689-e063-6394a90a64ef2026-06-14WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998525miconazole nitrate 2 % Topical SolutionPSN28a8d0dd-aab9-44ff-bab6-7ec4b5036a715
998525miconazole nitrate 20 MG/ML Topical SolutionSCD28a8d0dd-aab9-44ff-bab6-7ec4b5036a715
998525miconazole nitrate 2 % Topical SolutionSY28a8d0dd-aab9-44ff-bab6-7ec4b5036a715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-810-01633470810011 BOTTLE in 1 BOX (63347-810-01) / 15 mL in 1 BOTTLE1 bottle2016-04-010000-00-00NoNoCurrent