FDA.reportPublic FDA data

DB Antifungal foot

Product NDC
43689-0025
Requested package NDC
43689-0025-2
11-digit product format
436890025
Labeler code
43689
Product ID
43689-0025_ed7dca9a-826f-166c-e053-2995a90aef5d
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
The Magni Group Inc
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-04-27
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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 packagepackage43689-002543689-0025-2DDiscontinued by firm2026-10-21

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 packagepackage43689-002543689-0025-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43689-002543689-0025-2EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
43689-0025DB ANTIFUNGAL FOOT (MICONAZOLE NITRATE) CREAM [THE MAGNI GROUP INC]5Legacy NDC20231025_e206738e-6b24-4b03-a84f-7c2521d022ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43689-0025-2436890025021 JAR in 1 BOX (43689-0025-2) > 113 g in 1 JAR1 jar2017-04-270000-00-00NoNoCurrent