Antifungal

Product NDC
41250-080
11-digit product format
412500080
Labeler code
41250
Product ID
41250-080_38f98fba-d07b-1b27-e063-6394a90ab11a
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Meijer Distribution 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
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
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-080-022020-11-30C16284748780-19d75b9d1-21e7-f424-e053-dadaa90a57ceAntifungal Cream
41250-080-022020-01-31C16284748780-19d75b9d1-21e7-f424-e053-dadaa90a57ceAntifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-080-02Antifungal30 g in 1 TUBECREAM308
41250-080-02Antifungal1 in 1 CARTONCREAM18

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-080ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 2 package rows20250112_9daf3136-74b6-4410-8256-cbc9dd700f61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN9daf3136-74b6-4410-8256-cbc9dd700f618
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD9daf3136-74b6-4410-8256-cbc9dd700f618
992528terbinafine hydrochloride 1 % Topical CreamSY9daf3136-74b6-4410-8256-cbc9dd700f618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-080-02412500080021 TUBE in 1 CARTON (41250-080-02) / 30 g in 1 TUBE1 tube2012-12-120000-00-00NoNoCurrent