FDA.reportPublic FDA data

Kroger

Product NDC
30142-080
11-digit product format
301420080
Labeler code
30142
Product ID
30142-080_39fd935e-d3ca-dcb1-e063-6294a90af4e4
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Kroger Company
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
Kroger
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-080-012020-08-05C16284748780-19d75b9d0-1288-f424-e053-dadaa90a57ceKroger ® Antifungal
30142-080-012020-01-31C16284748780-19d75b9d0-1288-f424-e053-dadaa90a57ceKroger ® Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-080-01Kroger Antifungal15 g in 1 TUBECREAM154
30142-080-01Kroger Antifungal1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
TerbinafineACTIVE MOIETYG7RIW8S0XPKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2
waterINACTIVE INGREDIENT059QF0KO0RKROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-080KROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]3Current NDC, Legacy NDC, 2 package rows20200806_32e79416-5de4-4f06-9fff-f8c36a1ad5db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN32e79416-5de4-4f06-9fff-f8c36a1ad5db4
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD32e79416-5de4-4f06-9fff-f8c36a1ad5db4
992528terbinafine hydrochloride 1 % Topical CreamSY32e79416-5de4-4f06-9fff-f8c36a1ad5db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-080-01301420080011 TUBE in 1 CARTON (30142-080-01) / 15 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent