Miconazole Nitrate

Product NDC
56104-131
Requested package NDC
56104-131-46
11-digit product format
561040131
Labeler code
56104
Product ID
56104-131_c74070f8-d295-4f5c-e053-2995a90ad110
Type
HUMAN OTC DRUG
Nonproprietary name
Athletes Foot Powder Spray Talc Free
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-12-03
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
3 g/130g
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 packagepackage56104-13156104-131-46DDiscontinued 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 · 7 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 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…

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
56104-131-46Miconazole Nitrate130 g in 1 CANAEROSOL, POWDER13011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998428miconazole nitrate 2 % Powder SprayPSN605390fb-fc26-47a3-a445-22b325e162e111
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD605390fb-fc26-47a3-a445-22b325e162e111
998428miconazole nitrate 2 % Powder SpraySY605390fb-fc26-47a3-a445-22b325e162e111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-131-4656104013146130 g in 1 CAN (56104-131-46) 130 g2018-12-030000-00-00NoNoCurrent