FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
0363-3115
11-digit product format
003633115
Labeler code
0363
Product ID
0363-3115_c73ebe99-d95a-45a0-e053-2995a90a800e
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Walgreens Company
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
1 g/71g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-3115DDiscontinued by firm2026-10-05
excluded packagepackage0363-31150363-3115-25DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3115-252023-01-31C16284748780-1f386c649-993c-0266-e053-dadaa90a7c1aWalgreens Miconazorb Anti Fungal Powder - Talc Free
0363-3115-252023-01-30C16284748780-1f386c649-993c-0266-e053-dadaa90a7c1aWalgreens Miconazorb Anti Fungal Powder - Talc Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3115-25Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER718

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3115MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [WALGREENS COMPANY]8Legacy NDC, 1 package rows20241215_b58cbb23-8b25-430d-8fa6-5894184f4c3f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3115-250036331152571 g in 1 BOTTLE, PLASTIC (0363-3115-25) 71 g2018-06-010000-00-00NoNoCurrent