FDA.reportPublic FDA data

Silka

Product NDC
50066-080
11-digit product format
500660080
Labeler code
50066
Product ID
50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Genomma Lab USA, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
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
Silka
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992528, 1739221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-080-02Silka Antifungal30 g in 1 TUBECREAM307
50066-080-02Silka Antifungal1 in 1 CARTONCREAM17
50066-080-03Silka Antifungal30 g in 1 TUBECREAM307
50066-080-03Silka Antifungal1 in 1 CARTONCREAM17
50066-080-05Silka Antifungal15 g in 1 TUBECREAM157
50066-080-05Silka Antifungal1 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ISILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-080SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]6Current NDC, Legacy NDC, 6 package rows20240412_a32cf699-e63e-4bd3-a5af-9e1ba447e02e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739221SILKA 1 % Topical CreamPSNa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
992528terbinafine HCl 1 % Topical CreamPSNa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
1739221terbinafine hydrochloride 10 MG/ML Topical Cream [Silka Cream]SBDa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
1739221Silka 1 % Topical CreamSYa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
1739221Silka Cream 10 MG/ML Topical CreamSYa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
992528terbinafine hydrochloride 1 % Topical CreamSYa32cf699-e63e-4bd3-a5af-9e1ba447e02e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-080-02500660080021 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
50066-080-03500660080031 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE1 tube2018-05-210000-00-00NoNoCurrent
50066-080-05500660080051 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE1 tube2018-12-200000-00-00NoNoCurrent