CVS

Product NDC
59779-523
11-digit product format
597790523
Labeler code
59779
Product ID
59779-523_446e5c7a-48c9-cef4-e063-6294a90a6d32
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
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
CVS
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
59779-523-012025-11-25C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012025-07-29C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012024-04-30C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012023-01-30C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012021-06-18C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012020-01-31C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-523-01CVS1 in 1 CARTONCREAM14
59779-523-01CVS15 g in 1 TUBECREAM154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-523-01GM - Gram59779-523c6e9ed78-6829-46a3-b492-75485da0cb5122018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
TerbinafineACTIVE MOIETYG7RIW8S0XPCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1
waterINACTIVE INGREDIENT059QF0KO0RCVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-523CVS (TERBINAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]3Current NDC, Legacy NDC, 2 package rows20240502_17684ba2-3c2c-4259-84fa-3833f19e5a4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN17684ba2-3c2c-4259-84fa-3833f19e5a4d4
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD17684ba2-3c2c-4259-84fa-3833f19e5a4d4
992528terbinafine hydrochloride 1 % Topical CreamSY17684ba2-3c2c-4259-84fa-3833f19e5a4d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-523-01597790523011 TUBE in 1 CARTON (59779-523-01) / 15 g in 1 TUBE1 tube2008-12-090000-00-00NoNoCurrent