FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
0363-4208
11-digit product format
003634208
Labeler code
0363
Product ID
0363-4208_54a27c55-aca1-114e-e063-6394a90a1ff1
Type
HUMAN OTC DRUG
Nonproprietary name
Athletes Foot Liquid
Dosage form
SPRAY
Route
TOPICAL
Labeler
Walgreens Company
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-18
Substance
MICONAZOLE NITRATE
Active strength
3 g/150g
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
Miconazole Nitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE3 g/150g

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
998533Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
94f4f656-e8a3-4439-b53c-12be59dc8eacAvailable 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
0363-4208-53Miconazole Nitrate150 g in 1 CANSPRAY1509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4208-53GM - Gram0363-420809c7eb2d-cfbb-4ee7-acff-697f2bdaf84712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1
ACETONEINACTIVE INGREDIENT1364PS73AFMICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BMICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MICONAZOLE NITRATE (ATHLETES FOOT LIQUID SPRAY) SPRAY [WALGREENS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4208MICONAZOLE NITRATE (ATHLETES FOOT LIQUID) SPRAY [WALGREENS COMPANY]8Current NDC, Legacy NDC, 1 package rows20241215_94f4f656-e8a3-4439-b53c-12be59dc8eac.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 49 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4208-5300363420853150 g in 1 CAN (0363-4208-53) 150 g2010-05-180000-00-00NoNoCurrent