FDA.reportPublic FDA data

LAMISIL AT TERBINAFINE HYDROCHLORIDE

Product NDC
61047-139
11-digit product format
610470139
Labeler code
61047
Product ID
61047-139_3f018131-adda-6d1b-e063-6394a90a09f5
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Voyant Beauty, Inc.
Application
NDA020980
Marketing category
NDA
Marketing start
2024-08-21
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 TERBINAFINE HYDROCHLORIDE
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
61047-139-01LAMISIL AT TERBINAFINE HYDROCHLORIDE30 g in 1 TUBECREAM303
61047-139-01LAMISIL AT TERBINAFINE HYDROCHLORIDE1 in 1 CARTONCREAM13
61047-139-02LAMISIL AT TERBINAFINE HYDROCHLORIDE12 g in 1 TUBECREAM123
61047-139-02LAMISIL AT TERBINAFINE HYDROCHLORIDE1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61047-139LAMISIL AT TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [VOYANT BEAUTY, INC.]2Current NDC, 4 package rows20250104_1fd313ad-a3d9-6c86-e063-6394a90a7ae4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992530LamISIL AT 1 % Topical CreamPSN1fd313ad-a3d9-6c86-e063-6394a90a7ae43
992528terbinafine HCl 1 % Topical CreamPSN1fd313ad-a3d9-6c86-e063-6394a90a7ae43
992530terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]SBD1fd313ad-a3d9-6c86-e063-6394a90a7ae43
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD1fd313ad-a3d9-6c86-e063-6394a90a7ae43
992530Lamisil 10 MG/ML Topical CreamSY1fd313ad-a3d9-6c86-e063-6394a90a7ae43
992530Lamisil AT 1 % Topical CreamSY1fd313ad-a3d9-6c86-e063-6394a90a7ae43
992528terbinafine hydrochloride 1 % Topical CreamSY1fd313ad-a3d9-6c86-e063-6394a90a7ae43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61047-139-01610470139011 TUBE in 1 CARTON (61047-139-01) / 30 g in 1 TUBE1 tube2024-08-21NoNoCurrent
61047-139-02610470139021 TUBE in 1 CARTON (61047-139-02) / 12 g in 1 TUBE1 tube2025-01-06NoNoCurrent