Kopa Haiku Antifungal Cream

Product NDC
87041-004
11-digit product format
870410004
Labeler code
87041
Product ID
87041-004_521a9be6-4f5a-2055-e063-6394a90a71c2
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Trovina Co. Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-15
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kopa Haiku Antifungal Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87041-004-01Kopa Haiku Antifungal Cream60 g in 1 CARTONCREAM603

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN47cf1251-5965-045a-e063-6394a90ab04f3
998483miconazole nitrate 20 MG/ML Topical CreamSCD47cf1251-5965-045a-e063-6394a90ab04f3
998483miconazole nitrate 2 % Topical CreamSY47cf1251-5965-045a-e063-6394a90ab04f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87041-004-018704100040160 g in 1 CARTON (87041-004-01) 60 g2026-01-15NoNoHistorical