Kopa Haiku Antifungal Cream

Product NDC
87041-001
11-digit product format
870410001
Labeler code
87041
Product ID
87041-001_4a9fbe97-6b77-2709-e063-6294a90a009a
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
2025-11-14
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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87041-001-01Kopa Haiku Antifungal Cream100 g in 1 CARTONCREAM1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN431483f6-2386-9f5c-e063-6294a90af1043
998483miconazole nitrate 20 MG/ML Topical CreamSCD431483f6-2386-9f5c-e063-6294a90af1043
998483miconazole nitrate 2 % Topical CreamSY431483f6-2386-9f5c-e063-6294a90af1043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87041-001-0187041000101100 g in 1 CARTON (87041-001-01) 100 g2025-11-14NoNoCurrent