FDA.reportPublic FDA data

Miconatate

Product NDC
59088-778
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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui313423, 998461

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

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
59088-442-075908804420785 g in 1 BOTTLE85 gHistorical
59088-443-035908804430330 mL in 1 BOTTLE, WITH APPLICATOR30 mlHistorical
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