FDA.reportPublic FDA data

ANTIFUNGAL

Product NDC
84722-3057
11-digit product format
847223057
Labeler code
84722
Product ID
84722-3057_559304d0-3e66-df2c-e063-6294a90a0f14
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE
Dosage form
POWDER
Route
TOPICAL
Labeler
VIVE HEALTH LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-21
Substance
MICONAZOLE
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
ANTIFUNGAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7NNO0D7S5MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30dca43e-e6c4-8107-e063-6394a90a2b97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84722-3057-0ANTIFUNGAL1 g in 1 JARPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84722-3057ANTIFUNGAL (MICONAZOLE) POWDER [VIVE HEALTH LLC]1Current NDC, 1 package rows20250327_30dca43e-e6c4-8107-e063-6394a90a2b97.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 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZERALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.88a14b15-09d6-45de-97b6-cddce7ca420b2025-04-19WarningsExact identifier
application number: M005
ELLEN HAND SANITIZERETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA33077eab-e686-249d-e063-6394a90a1b6d2025-04-18WarningsExact identifier
application number: M005
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
application number: M005
ANTIBACTERIAL HAND SANITIZERETHYL ALCOHOLASC Marketing Ltd.b42ebe64-0cad-2d26-e053-2a95a90af3dd2025-04-07WarningsExact identifier
application number: M005
Anti-Bacterial HAND SANITIZERETHYL ALCOHOLDISNEY DESTINATIONS,LLCae739bda-edf3-634b-e053-2a95a90a73852025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc9ae42862-f730-9d67-e053-2a95a90af9552025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc7e8f4517-c996-8797-e053-2991aa0a4f582025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.43ab2651-6e0a-3d48-e054-00144ff88e882025-04-07WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATETAGRID LLC32396be0-f74a-5483-e063-6294a90ab3ae2025-04-07WarningsExact identifier
application number: M005
Antifungal Treatment Liquid 25 undeclylenic AcidUNDECYLENIC ACIDSANSAR, LLC2ae0f300-154e-44c8-bcc3-b5c334e661ac2025-04-02WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
application number: M005
Tagrid Jock Itch Miconazole Nitrate 2%MICONAZOLE NITRATETAGRID LLC31abdc68-5027-15e7-e063-6394a90ac4e62025-03-31WarningsExact identifier
application number: M005
Tea Tree Oil Foot Soak and Body SoakZINC UNDECYLENATESANSAR, LLCc43816ac-2228-43ce-ba45-80cf3a7788f22025-03-28WarningsExact identifier
application number: M005
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsExact identifier
application number: M005
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
application number: M005
1236-CS Antifungal Powder (Talc Free)1236-CCANTIFUNGAL POWDER(TALC FREE)Dynarex Corporation312ba573-4008-83e6-e063-6294a90a4a6d2025-03-25WarningsExact identifier
application number: M005
Antifungal Medicated BarTOLNAFTATERoyceDerm LLC31305ed2-a0a0-6d4c-e063-6294a90a6ba52025-03-25WarningsExact identifier
application number: M005
Forticept Antimicrobial Hydrogel Wound DressingBENZETHONIUM CHLORIDE, THYMOLLidan, Inccd5b7a72-1b87-434d-973e-071d2c8a438c2025-03-25WarningsExact identifier
application number: M005
Forticept HP Antiseptic Wound CleanserBENZALKONIUM CHLORIDE, ALLANTOINLidan, inc.41bb46ee-edce-4e1b-bcfd-5c5729e1eb152025-03-25WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84722-3057-0847223057001 g in 1 JAR1 gHistorical
84722-3057-1847223057011 g in 1 JAR (84722-3057-1) 1 g2025-03-21NoNoCurrent