FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
70000-0323
Requested package NDC
70000-0323-1
11-digit product format
700000323
Labeler code
70000
Product ID
70000-0323_f2033964-f353-4ea4-e053-2a95a90a4151
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Cardinal Health
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-10-20
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
1 g/71g
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 packagepackage70000-032370000-0323-1DDiscontinued 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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0323-1Miconazole Nitrate71 g in 1 BOTTLE, WITH APPLICATORPOWDER719

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0323-1GM - Gram70000-0323a3b9e495-fa7c-435e-aa75-a1aefc4f9d9712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0323MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [LEADER/ CARDINAL HEALTH 110, INC.]9Legacy NDC, 1 package rows20241222_e754d590-0a92-4605-89a3-e698b8906672.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREELEADER/ Cardinal Health 110, Inc.e754d590-0a92-4605-89a3-e698b89066722024-12-20WarningsExact identifier
ndc (package): 70000-0323-1
ndc (product): 70000-0323
ndc11 (package): 70000032301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNe754d590-0a92-4605-89a3-e698b89066729
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDe754d590-0a92-4605-89a3-e698b89066729
998461miconazole nitrate 2 % Topical PowderSYe754d590-0a92-4605-89a3-e698b89066729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0323-17000003230171 g in 1 BOTTLE, WITH APPLICATOR (70000-0323-1) 71 g2017-10-200000-00-00NoNoCurrent