FDA.reportPublic FDA data

Cura Hongo

Product NDC
55758-102
11-digit product format
557580102
Labeler code
55758
Product ID
55758-102_43d08a3e-0caf-49ed-e063-6294a90af5f2
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-31
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
Cura Hongo
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

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
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-102-02Cura HongoAntifungal56.7 g in 1 TUBECREAM56.77
55758-102-02Cura HongoAntifungal1 in 1 CARTONCREAM17
55758-102-03Cura HongoAntifungal1 in 1 CARTONCREAM17
55758-102-03Cura HongoAntifungal57 g in 1 TUBECREAM577

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-102CURA HONGO ANTIFUNGAL (CLOTRIMAZOLE) CREAM [PHARMADEL LLC]5Current NDC, Legacy NDC, 4 package rows20241210_df031309-2778-00cf-e053-2a95a90a5eea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNdf031309-2778-00cf-e053-2a95a90a5eea7
309367clotrimazole 10 MG/ML Topical CreamSCDdf031309-2778-00cf-e053-2a95a90a5eea7
309367clotrimazole 1 % Topical CreamSYdf031309-2778-00cf-e053-2a95a90a5eea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-102-02557580102021 TUBE in 1 CARTON (55758-102-02) > 56.7 g in 1 TUBE1 tube2022-05-310000-00-00NoNoCurrent
55758-102-03557580102031 TUBE in 1 CARTON (55758-102-03) / 57 g in 1 TUBE1 tube2026-01-01NoNoCurrent