FDA.reportPublic FDA data

Miconazole Nitrate Cream 2%

Product NDC
79503-106
11-digit product format
795030106
Labeler code
79503
Product ID
79503-106_43fbeab5-738f-4257-8ac3-b7b66c29c9e0
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Ezricare Llc
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-08-19
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct79503-106DDiscontinued by firm2026-10-15
excluded packagepackage79503-10679503-106-30DDiscontinued by firm2026-10-15

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage79503-106-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage79503-106-30f5e01cc5f278…a2eaf40c39c3…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79503-106-30GM - Gram79503-1066bf6d148-fb76-4c54-ba53-678c126dd76312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79503-106MICONAZOLE NITRATE CREAM 2% (MICONAZOLE NITRATE) CREAM [EZRICARE LLC]2Legacy NDC20240112_8c9ea04d-b51b-434c-8fb7-dd13ab8f1f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNf990672c-d959-38f2-e053-6394a90a80251
998483miconazole nitrate 20 MG/ML Topical CreamSCDf990672c-d959-38f2-e053-6394a90a80251
998483miconazole nitrate 2 % Topical CreamSYf990672c-d959-38f2-e053-6394a90a80251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79503-106-30795030106301 TUBE in 1 CARTON (79503-106-30) > 30 g in 1 TUBE1 tube2021-08-190000-00-00NoNoCurrent