FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
41250-196
Requested package NDC
41250-196-46
11-digit product format
412500196
Labeler code
41250
Product ID
41250-196_f2047f00-c3f6-3e18-e053-2a95a90af35f
Type
HUMAN OTC DRUG
Nonproprietary name
Athletes Foot Powder Spray Talc Free
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-04-04
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
2024-12-31
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 packagepackage41250-19641250-196-46DDiscontinued by firm2026-10-05

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-196-46Miconazole Nitrate130 g in 1 CANAEROSOL, POWDER1306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-196MICONAZOLE NITRATE (ATHLETES FOOT POWDER SPRAY TALC FREE) AEROSOL, POWDER [MEIJER DISTRIBUTION INC]6Legacy NDC, 1 package rows20241016_0201dfee-75a3-4aad-9dee-eedc38db1758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998428miconazole nitrate 2 % Powder SprayPSN0201dfee-75a3-4aad-9dee-eedc38db17586
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD0201dfee-75a3-4aad-9dee-eedc38db17586
998428miconazole nitrate 2 % Powder SpraySY0201dfee-75a3-4aad-9dee-eedc38db17586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-196-4641250019646130 g in 1 CAN (41250-196-46) 130 g2018-04-040000-00-00NoNoCurrent