FDA.reportPublic FDA data

Lamisil AT Cream

Product NDC
61047-120
11-digit product format
610470120
Labeler code
61047
Product ID
61047-120_43e44bcd-a7df-399e-e063-6394a90a65a3
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Voyant Beauty Inc.
Application
NDA020980
Marketing category
NDA
Marketing start
2020-02-20
Marketing end
2027-05-31
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamisil AT Cream

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
61047-120-01Lamisil AT Cream1 in 1 CARTONCREAM16
61047-120-01Lamisil AT Cream12 g in 1 TUBECREAM126
61047-120-02Lamisil AT Cream12 g in 1 TUBECREAM126
61047-120-02Lamisil AT Cream1 in 1 CARTONCREAM16
61047-120-03Lamisil AT Cream1 in 1 CARTONCREAM16
61047-120-03Lamisil AT Cream30 g in 1 TUBECREAM306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61047-120LAMISIL AT CREAM (TERBINAFINE HYDROCHLORIDE) CREAM [VOYANT BEAUTY INC.]3Current NDC, Legacy NDC, 6 package rows20210101_9dea4789-bf1c-1577-e053-2a95a90a5381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992530LamISIL AT 1 % Topical CreamPSN9dea4789-bf1c-1577-e053-2a95a90a53816
992528terbinafine HCl 1 % Topical CreamPSN9dea4789-bf1c-1577-e053-2a95a90a53816
992530terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]SBD9dea4789-bf1c-1577-e053-2a95a90a53816
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD9dea4789-bf1c-1577-e053-2a95a90a53816
992530Lamisil 10 MG/ML Topical CreamSY9dea4789-bf1c-1577-e053-2a95a90a53816
992530Lamisil AT 1 % Topical CreamSY9dea4789-bf1c-1577-e053-2a95a90a53816
992528terbinafine hydrochloride 1 % Topical CreamSY9dea4789-bf1c-1577-e053-2a95a90a53816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61047-120-01610470120011 TUBE in 1 CARTON (61047-120-01) > 12 g in 1 TUBE1 tube2020-02-240000-00-00NoNoCurrent
61047-120-02610470120021 TUBE in 1 CARTON (61047-120-02) > 12 g in 1 TUBE1 tube2020-03-020000-00-00NoNoCurrent
61047-120-03610470120031 TUBE in 1 CARTON (61047-120-03) / 30 g in 1 TUBE1 tube2020-02-202027-05-31NoNoCurrent