Curist

Product NDC
72559-035
11-digit product format
725590035
Labeler code
72559
Product ID
72559-035_37a42ef8-419e-aad9-e063-6294a90a6a2a
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Little Pharma, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2024-12-10
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Curist
Brand name suffix
Antifungal Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992528

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72559-035-58CuristAntifungal Relief30 g in 1 TUBECREAM303
72559-035-58CuristAntifungal Relief1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-035CURIST ANTIFUNGAL RELIEF (TERBINAFINE HYDROCHLORIDE) CREAM [LITTLE PHARMA, INC.]2Current NDC, 2 package rows20250221_28f13725-48d1-8774-e063-6394a90a6704.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN28f13725-48d1-8774-e063-6394a90a67043
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD28f13725-48d1-8774-e063-6394a90a67043
992528terbinafine hydrochloride 1 % Topical CreamSY28f13725-48d1-8774-e063-6394a90a67043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72559-035-58725590035581 TUBE in 1 CARTON (72559-035-58) / 30 g in 1 TUBE1 tube2024-12-10NoNoHistorical