Athletes Foot

Product NDC
63868-364
11-digit product format
638680364
Labeler code
63868
Product ID
63868-364_f7c65393-e192-47eb-8272-9ab447c41ee1
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-364-122020-01-31C16284748780-19d75b9cf-e453-f424-e053-dadaa90a57ceAthlete's Foot Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-364-12Athletes Foot15 g in 1 TUBECREAM151
63868-364-12Athletes Foot1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-364-12GM - Gram63868-36490ebbc0b-a14a-4b97-b27f-1d2910f68bc512013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-364ATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Legacy NDC, 2 package rows20121212_75808698-acfd-4727-a837-461465019e0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN75808698-acfd-4727-a837-461465019e0e1
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD75808698-acfd-4727-a837-461465019e0e1
992528terbinafine hydrochloride 1 % Topical CreamSY75808698-acfd-4727-a837-461465019e0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-364-126386803641215 g in 1 TUBE15 gHistorical