Lamisil AT Cream

Product NDC
84485-3607
11-digit product format
844853607
Labeler code
84485
Product ID
84485-3607_dc1dfa6d-7d6d-43cf-a25a-8497e3430bcd
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Karo Healthcare Inc.
Application
NDA020980
Marketing category
NDA
Marketing start
2025-01-20
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84485-3607-1Lamisil AT Cream1 in 1 CARTONCREAM11
84485-3607-1Lamisil AT Cream12 g in 1 TUBECREAM121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84485-3607LAMISIL AT CREAM (TERBINAFINE HYDROCHLORIDE) CREAM [KARO HEALTHCARE INC.]1Current NDC, 2 package rows20250120_0f59271d-997f-4dcc-aae3-900b53df1c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992530LamISIL AT 1 % Topical CreamPSN0f59271d-997f-4dcc-aae3-900b53df1c951
992528terbinafine HCl 1 % Topical CreamPSN0f59271d-997f-4dcc-aae3-900b53df1c951
992530terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]SBD0f59271d-997f-4dcc-aae3-900b53df1c951
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD0f59271d-997f-4dcc-aae3-900b53df1c951
992530Lamisil 10 MG/ML Topical CreamSY0f59271d-997f-4dcc-aae3-900b53df1c951
992530Lamisil AT 1 % Topical CreamSY0f59271d-997f-4dcc-aae3-900b53df1c951
992528terbinafine hydrochloride 1 % Topical CreamSY0f59271d-997f-4dcc-aae3-900b53df1c951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84485-3607-1844853607011 TUBE in 1 CARTON (84485-3607-1) / 12 g in 1 TUBE1 tube2025-01-20NoNoHistorical