FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
56104-020
Requested package NDC
56104-020-25
11-digit product format
561040020
Labeler code
56104
Product ID
56104-020_c73fe7b3-b220-f2fc-e053-2a95a90a059b
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazorb AF Powder
Dosage form
POWDER
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-01-01
Marketing end
2021-12-31
Substance
MICONAZOLE NITRATE
Active strength
1 g/71g
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage56104-02056104-020-25DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]1
ALDIOXAINACTIVE INGREDIENT8T66I31YNKMICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]1
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2QMICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]1
IMIDUREAINACTIVE INGREDIENTM629807ATLMICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MMICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-020-255610400202571 g in 1 BOTTLE, PLASTIC (56104-020-25) 71 g2013-01-012021-12-31NoNoCurrent