Mycozyl AC

Product NDC
59088-441
11-digit product format
590880441
Labeler code
59088
Product ID
59088-441_23740ac5-b214-253d-e063-6394a90a1951
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-06
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
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 AC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-441-07Mycozyl AC85 g in 1 TUBECREAM855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-441MYCOZYL AC (CLOTRIMAZOLE) CREAM [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_b676d257-3cfd-7f24-e053-2995a90a546e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNb676d257-3cfd-7f24-e053-2995a90a546e5
309367clotrimazole 10 MG/ML Topical CreamSCDb676d257-3cfd-7f24-e053-2995a90a546e5
309367clotrimazole 1 % Topical CreamSYb676d257-3cfd-7f24-e053-2995a90a546e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-441-075908804410785 g in 1 TUBE (59088-441-07) 85 g2021-04-060000-00-00NoNoCurrent