FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
46122-444
Requested package NDC
46122-444-27
11-digit product format
461220444
Labeler code
46122
Product ID
46122-444_c791d585-a95f-5db0-e053-2995a90a71a9
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
AmerisourceBergen Drug Corporation
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-08-08
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-44446122-444-27DDiscontinued 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-444-27Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-444-27GM - Gram46122-4445cdf03e4-ea24-4d38-8fd7-e18424cfd3cc12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-444MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [AMERISOURCEBERGEN DRUG CORPORATION]7Legacy NDC, 1 package rows20241208_9cd8f0b0-1e63-4e8c-b0a0-e5da6abaf49a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-444-274612204442771 g in 1 BOTTLE, PLASTIC (46122-444-27) 71 g2017-08-080000-00-00NoNoCurrent