FDA.reportPublic FDA data

Walgreens

Product NDC
0363-2080
11-digit product format
003632080
Labeler code
0363
Product ID
0363-2080_4481f6a3-e78b-6f25-e063-6294a90af994
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreen 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
Walgreens
Brand name suffix
Athletes Foot
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
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-2080-012025-11-26C16284748780-13b156c62-321d-fb37-e063-e6dba90a4e07Walgreens Athlete's Foot
0363-2080-022025-11-26C16284748780-13b156c62-321d-fb37-e063-e6dba90a4e07Walgreens Athlete's Foot
0363-2080-012025-07-29C16284748780-13b156c62-321d-fb37-e063-e6dba90a4e07Walgreens Athlete's Foot
0363-2080-022025-07-29C16284748780-13b156c62-321d-fb37-e063-e6dba90a4e07Walgreens Athlete's Foot

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2080-01WalgreensAthletes Foot15 g in 1 TUBECREAM155
0363-2080-01WalgreensAthletes Foot1 in 1 CARTONCREAM15
0363-2080-02WalgreensAthletes Foot1 in 1 CARTONCREAM15
0363-2080-02WalgreensAthletes Foot30 g in 1 TUBECREAM305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-2080-01GM - Gram0363-2080ba05ce57-e33f-4973-8317-236d3d87dbf212019-08-06
0363-2080-02GM - Gram0363-208076203331-2b5e-457f-ab84-2a6cd870942512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2080WALGREENS ATHLETES FOOT (TERBINAFINE HYDROCHLORIDE) CREAM [WALGREEN COMPANY]4Current NDC, Legacy NDC, 4 package rows20240407_d706c56f-0123-4a5a-8c85-240cbe6ef7a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSNd706c56f-0123-4a5a-8c85-240cbe6ef7a55
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDd706c56f-0123-4a5a-8c85-240cbe6ef7a55
992528terbinafine hydrochloride 1 % Topical CreamSYd706c56f-0123-4a5a-8c85-240cbe6ef7a55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-2080-01003632080011 TUBE in 1 CARTON (0363-2080-01) / 15 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
0363-2080-02003632080021 TUBE in 1 CARTON (0363-2080-02) / 30 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent