FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
36800-385
Requested package NDC
36800-385-25
11-digit product format
368000385
Labeler code
36800
Product ID
36800-385_c77f7dfd-9fbc-534e-e053-2995a90a72e4
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Topco Associates LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-07
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
1 g/71g
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 packagepackage36800-38536800-385-25DDiscontinued by firm2026-11-02

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-385-252023-01-31C16284748780-1f386c64a-0209-0266-e053-dadaa90a7c1aTopcare Miconazorb Anti Fungal Powder Talc Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-385-25Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-385-25GM - Gram36800-385e5547636-3587-4e2a-ac8e-4883fce6745c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-385MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [TOPCO ASSOCIATES LLC]7Legacy NDC, 1 package rows20241109_0afaf920-e30a-4a7c-a19e-558b31ae7e58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN0afaf920-e30a-4a7c-a19e-558b31ae7e587
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD0afaf920-e30a-4a7c-a19e-558b31ae7e587
998461miconazole nitrate 2 % Topical PowderSY0afaf920-e30a-4a7c-a19e-558b31ae7e587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-385-253680003852571 g in 1 BOTTLE, PLASTIC (36800-385-25) 71 g2017-12-070000-00-00NoNoCurrent