Mycozyl AP

Product NDC
59088-442
11-digit product format
590880442
Labeler code
59088
Product ID
59088-442_237410ce-a7e8-47ec-e063-6394a90a89a2
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
PureTek Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-08
Substance
MICONAZOLE NITRATE
Active strength
2 g/85g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/85g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998461

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
59088-442-07Mycozyl AP85 g in 1 BOTTLEPOWDER855
59088-442-07Miconatate85 g in 1 BOTTLEPOWDER1 g in 852 g in 85g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-442-07GM - Gram59088-442a66781bb-9566-4809-ae1c-284af56e1e9612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-442MYCOZYL AP (MICONAZOLE NITRATE) POWDER [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_b3c46a30-7ff2-0dc4-e053-2995a90aa571.zip
59088-442MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNb3c46a30-7ff2-0dc4-e053-2995a90aa5715
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDb3c46a30-7ff2-0dc4-e053-2995a90aa5715
998461miconazole nitrate 2 % Topical PowderSYb3c46a30-7ff2-0dc4-e053-2995a90aa5715
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 BOTTLE (59088-442-07) 85 g2020-12-080000-00-00NoNoCurrent