Miconazole Nitrate

Product NDC
37808-520
Requested package NDC
37808-520-53
11-digit product format
378080520
Labeler code
37808
Product ID
37808-520_c79263a0-1600-b9ed-e053-2995a90af4a0
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal Liquid Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
HEB
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-17
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
3 g/150g
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 packagepackage37808-52037808-520-53DDiscontinued by firm2026-10-23

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 packagepackage37808-52037808-520-53DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-52037808-520-53DDiscontinued 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
37808-520MICONAZOLE NITRATE (ANTIFUNGAL LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [HEB]6Legacy NDC20241212_bfa0ba85-f88b-4610-8538-2f6e1b444516.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-520-5337808052053150 g in 1 CAN (37808-520-53) 150 g2012-01-170000-00-00NoNoCurrent