Lamisil AT

Product NDC
84485-3605
11-digit product format
844853605
Labeler code
84485
Product ID
84485-3605_21f1bf77-4338-4b75-b513-80a0d98a722a
Type
HUMAN OTC DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Karo Healthcare Inc.
Application
NDA021124
Marketing category
NDA
Marketing start
2025-12-10
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992535, 992536

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
84485-3605-4Lamisil AT120 g in 1 CANSPRAY1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992536LamISIL AT 1 % Topical SprayPSN21f1bf77-4338-4b75-b513-80a0d98a722a1
992535terbinafine HCl 1 % Topical SprayPSN21f1bf77-4338-4b75-b513-80a0d98a722a1
992536terbinafine hydrochloride 10 MG/ML Topical Spray [Lamisil]SBD21f1bf77-4338-4b75-b513-80a0d98a722a1
992535terbinafine hydrochloride 10 MG/ML Topical SpraySCD21f1bf77-4338-4b75-b513-80a0d98a722a1
992536Lamisil 1 % Topical SpraySY21f1bf77-4338-4b75-b513-80a0d98a722a1
992536Lamisil 10 MG/ML Topical SpraySY21f1bf77-4338-4b75-b513-80a0d98a722a1
992536Lamisil AT 1 % Topical SpraySY21f1bf77-4338-4b75-b513-80a0d98a722a1
992535terbinafine hydrochloride 1 % Topical SpraySY21f1bf77-4338-4b75-b513-80a0d98a722a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84485-3605-484485360504120 g in 1 CAN (84485-3605-4) 120 g2025-12-10NoNoHistorical