FDA.reportPublic FDA data

Miconatate

Product NDC
59088-778
Requested package NDC
59088-778-00
11-digit product format
590880778
Labeler code
59088
Product ID
59088-778_249cf0cd-2c2a-95a1-e063-6394a90af393
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate and Tolnaftate
Dosage form
KIT
Labeler
PureTek Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Miconatate
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c45c8f8f-9042-a428-e053-2a95a90acda9Available on FDA.report

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
59088-442-07Miconatate85 g in 1 BOTTLEPOWDER1 g in 852 g in 85g3
59088-443-03Miconatate30 mL in 1 BOTTLE, WITH APPLICATORLIQUID1 mL in 300.3 g in 30mL3
59088-778-00Miconatate1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-778-00EA - Each59088-778b3a7207e-e755-4651-939b-5dbbfdfb700412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-778MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC, 3 package rows20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.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
MiconatateMICONAZOLE NITRATE AND TOLNAFTATEPureTek Corporationc45c8f8f-9042-a428-e053-2a95a90acda92024-10-16WarningsExact identifier
ndc (package): 59088-778-00
ndc (product): 59088-778
ndc11 (package): 59088077800

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 1 % Topical SolutionPSNc45c8f8f-9042-a428-e053-2a95a90acda93
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 10 MG/ML Topical SolutionSCDc45c8f8f-9042-a428-e053-2a95a90acda93
998461miconazole nitrate 2 % Topical PowderSYc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 1 % Topical SolutionSYc45c8f8f-9042-a428-e053-2a95a90acda93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-778-00590880778001 KIT in 1 CARTON (59088-778-00) * 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) * 85 g in 1 BOTTLE (59088-442-07) 1 kit2021-09-020000-00-00NoNoCurrent