LAMISIL

Product NDC
0067-6293
11-digit product format
000676293
Labeler code
0067
Product ID
0067-6293_49a90243-d16c-458c-ab1b-9d56c750d57a
Type
HUMAN OTC DRUG
Nonproprietary name
TERBINAFINE HYDROCHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
GlaxoSmithKline Consumer
Application
NDA021124
Marketing category
NDA
Marketing start
2009-07-23
Marketing end
2019-03-31
Substance
TERBINAFINE HYD
Active strength
1 g/125mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0067-6293DDiscontinued by firm2026-08-10
excluded packagepackage0067-62930067-6293-83DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0067-6293-83d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0067-6293-83f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0067-6293-832ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0067-6293-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0067-6293-83cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0067-6293-83cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0067-6293-83302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0067-6293-83ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0067-6293-830efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0067-6293-83ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0067-6293-83367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0067-6293-83557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021124-001LAMISIL ATTERBINAFINE HYDROCHLORIDE1%SOLUTION / TOPICALRLD, RS2000-03-17
N021124-002LAMISIL ATTERBINAFINE HYDROCHLORIDE1%SPRAY / TOPICALRLD, RS2000-03-17

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17782e0a99824c…
2021-12-28 21:50 UTC2021-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6293-83ML - Milliliter0067-62931eafdc82-7dfa-4915-9f4e-3c381bebeede12012-07-24

DailyMed Socrata Ingredients#

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.21f1bf77-4338-4b75-b513-80a0d98a722a2025-12-12WarningsExact identifier
application applno (NDA): 021124
application number: NDA021124
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.d3e75665-e2d4-47d9-baaa-93817b5fbf002025-12-12WarningsExact identifier
application applno (NDA): 021124
application number: NDA021124

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992536LamISIL AT 1 % Topical SprayPSN792eb340-7202-4c06-b488-033ca8a638593
992535terbinafine HCl 1 % Topical SprayPSN792eb340-7202-4c06-b488-033ca8a638593
992536terbinafine hydrochloride 10 MG/ML Topical Spray [Lamisil]SBD792eb340-7202-4c06-b488-033ca8a638593
992535terbinafine hydrochloride 10 MG/ML Topical SpraySCD792eb340-7202-4c06-b488-033ca8a638593
992536Lamisil 1 % Topical SpraySY792eb340-7202-4c06-b488-033ca8a638593
992536Lamisil 10 MG/ML Topical SpraySY792eb340-7202-4c06-b488-033ca8a638593
992536Lamisil AT 1 % Topical SpraySY792eb340-7202-4c06-b488-033ca8a638593
992535terbinafine hydrochloride 1 % Topical SpraySY792eb340-7202-4c06-b488-033ca8a638593