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 firm2026-10-05

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

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

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 FREETopco Associates LLC0afaf920-e30a-4a7c-a19e-558b31ae7e582024-11-07WarningsExact identifier
ndc (package): 36800-385-25
ndc (product): 36800-385
ndc11 (package): 36800038525

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