Antifungal Miconazole

Product NDC
56104-256
Requested package NDC
56104-256-01
11-digit product format
561040256
Labeler code
56104
Product ID
56104-256_ec8046a4-1967-3d86-e053-2995a90aaf5d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-29
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
3 g/130g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage56104-25656104-256-01DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage56104-25656104-256-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56104-25656104-256-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-256ANTIFUNGAL MICONAZOLE (MICONAZOLE NITRATE) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]4Legacy NDC20241016_ec801b6b-7787-a1aa-e053-2995a90a3233.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-256-0156104025601130 g in 1 CANISTER (56104-256-01) 130 g2022-11-020000-00-00NoNoCurrent