Home NDC 84485-3605 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021124-001 LAMISIL AT TERBINAFINE HYDROCHLORIDE 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 N021124-002 LAMISIL AT TERBINAFINE HYDROCHLORIDE 1% SPRAY / TOPICAL RLD, RS 2000-03-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021124-001 LAMISIL AT 1% SOLUTION / TOPICAL RLD, RS 2000-03-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021124-002 LAMISIL AT 1% SPRAY / TOPICAL RLD, RS 2000-03-17 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Lamisil AT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBINAFINE HYDROCHLORIDE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 012C11ZU6G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992535 Internal RxNorm lookup 992536 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84485-3605-4 Lamisil AT 120 g in 1 CAN SPRAY 120 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84485-3605-4 84485360504 120 g in 1 CAN (84485-3605-4) 120 g 2025-12-10 No No Current