Lamisil AT Cream

Product NDC
84485-3748
11-digit product format
844853748
Labeler code
84485
Product ID
84485-3748_58726dc3-45ee-4543-8863-3949940fb64e
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Karo Healthcare Inc.
Application
NDA020980
Marketing category
NDA
Marketing start
2024-11-01
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
Lamisil AT Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992528, 992530

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84485-3748-3Lamisil AT Cream1 in 1 CARTONCREAM12
84485-3748-3Lamisil AT Cream30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84485-3748LAMISIL AT CREAM (TERBINAFINE HYDROCHLORIDE) CREAM [KARO HEALTHCARE INC.]2Current NDC, 2 package rows20250116_7f8434c2-60c9-4aeb-b0b8-f69107e74609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992530LamISIL AT 1 % Topical CreamPSN7f8434c2-60c9-4aeb-b0b8-f69107e746092
992528terbinafine HCl 1 % Topical CreamPSN7f8434c2-60c9-4aeb-b0b8-f69107e746092
992530terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]SBD7f8434c2-60c9-4aeb-b0b8-f69107e746092
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD7f8434c2-60c9-4aeb-b0b8-f69107e746092
992530Lamisil 10 MG/ML Topical CreamSY7f8434c2-60c9-4aeb-b0b8-f69107e746092
992530Lamisil AT 1 % Topical CreamSY7f8434c2-60c9-4aeb-b0b8-f69107e746092
992528terbinafine hydrochloride 1 % Topical CreamSY7f8434c2-60c9-4aeb-b0b8-f69107e746092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84485-3748-3844853748031 TUBE in 1 CARTON (84485-3748-3) / 30 g in 1 TUBE1 tube2024-11-01NoNoHistorical