Alaway

Product NDC
24208-901
11-digit product format
242080901
Labeler code
24208
Product ID
24208-901_9e5875e8-5082-4d6a-b28c-69b9d2bc6a57
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
KIT
Labeler
Bausch & Lomb Incorporated
Application
NDA021996
Marketing category
NDA
Marketing start
2006-12-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct24208-901DDiscontinued by firm2026-08-10
excluded packagepackage24208-90124208-901-99DDiscontinued 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 packagepackage24208-901-99d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24208-901-99f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24208-901-992ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24208-901-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24208-901-99cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24208-901-99cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24208-901-99302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24208-901-99ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24208-901-990efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24208-901-99ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24208-901-99367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24208-901-99557ba5c1ecfa…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
N021996-001ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01
N021996-002CHILDREN'S ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11

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 UTC2026-02N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11782e0a99824c…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Itch ReliefKETOTIFEN FUMARATERedpharm Drug52c62397-58f1-d34d-e063-6294a90a6faf2026-05-27WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATEWalgreen Company9ce8f926-c202-40d1-9dba-0477f1f49e142026-03-25WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Ketotifen FumarateKETOTIFEN FUMARATERugby Laboratories8aa81ae9-112a-49fa-a0cb-ed0217a40de52026-03-20WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATECVS Pharmacy7d0146a9-5073-4e24-954f-75b84affadc22026-01-15WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATEPERRIGO DIRECT INC.d3049296-0d15-4523-883c-25f8817bc7352026-01-15WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATETarget Corporationb25106f8-436e-4c06-8780-b12368ede9fe2025-03-28WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATEA-S Medication Solutionsb0eb7b54-4f4e-4ca2-8e4e-30d18d6624012024-10-01WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReleifKETOTIFEN FUMARATERite Aid Corporation6a7be1e9-27ff-44d8-85ed-fc1b0017180e2024-07-22WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATESafeway5fccbb63-7859-484c-b7b3-9de711364c092024-05-16WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATECardinal Healthe5fd1246-c4a7-4be3-a3d3-83d82ec6cab82023-12-08WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATETOPCO ASSOCIATES LLCb723daa3-6c6f-4a96-a15d-0d5866f28ca42023-12-08WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Eye Itch ReliefKETOTIFEN FUMARATEKroger Companyeb81286f-72b4-42b3-a596-439d0aeae93f2023-12-08WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Ketotifen FumarateKETOTIFEN FUMARATEA-S Medication Solutions1234de19-257c-422c-8706-1239381a27062023-05-11WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
AlawayKETOTIFEN FUMARATEBausch & Lomb Incorporatede4c310b5-1dba-4ddc-bc90-b27ebc7658712022-05-01WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996
Equate Eye Itch ReliefKETOTIFEN FUMARATEWal-Mart Stores, Inc.accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb92021-03-23WarningsExact identifier
application applno (NDA): 021996
application number: NDA021996