Alaway

Product NDC: 24208-601
Requested package NDC: 24208-601-90
11-digit product format: 242080601
Labeler code: 24208
Product ID: 24208-601_4f27a942-b5f3-4a01-8022-49deced585f8
Type: HUMAN OTC DRUG
Nonproprietary name: Ketotifen Fumarate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA021996
Marketing category: NDA
Marketing start: 2006-12-01
Substance: KETOTIFEN FUMARATE
Active strength: .25 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021996-001	ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2006-12-01
N021996-002	CHILDREN'S ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2015-02-11

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Alaway
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOTIFEN FUMARATE	.25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HBD503WORO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311237	Internal RxNorm lookup
707594	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e4c310b5-1dba-4ddc-bc90-b27ebc765871	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229	Product name	1	20221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-601-05	Alaway	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	15
24208-601-05	Alaway	1 in 1 CARTON	SOLUTION/ DROPS	1	15
24208-601-10	Alaway	1 in 1 CARTON	SOLUTION/ DROPS	1	15
24208-601-10	Alaway	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	15
24208-601-90	Alaway	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	15
24208-601-90	Alaway	2 in 1 CARTON	SOLUTION/ DROPS	2	15
24208-601-95	Alaway	1 in 1 CARTON	SOLUTION/ DROPS	1	15
24208-601-95	Alaway	1 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	1	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-601-05	ML - Milliliter	24208-601	70e262e3-9f7f-4665-a66e-102f74ef9ad2	1	2014-05-02
24208-601-10	ML - Milliliter	24208-601	210a1fc5-ef5f-4d05-a59b-769c7b5c1bd1	1	2012-07-24
24208-601-90	ML - Milliliter	24208-601	8b54b237-79e9-4a15-8081-78eb258b09de	1	2025-11-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOTIFEN FUMARATE	ACTIVE INGREDIENT	HBD503WORO	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
KETOTIFEN	ACTIVE MOIETY	X49220T18G	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-601	ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	15	Current NDC, Legacy NDC, 8 package rows	20220518_e4c310b5-1dba-4ddc-bc90-b27ebc765871.zip

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Itch Relief	KETOTIFEN FUMARATE	CVS Pharmacy	7d0146a9-5073-4e24-954f-75b84affadc2	2026-08-31	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Redpharm Drug	52c62397-58f1-d34d-e063-6294a90a6faf	2026-05-27	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Walgreen Company	9ce8f926-c202-40d1-9dba-0477f1f49e14	2026-03-25	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Ketotifen Fumarate	KETOTIFEN FUMARATE	Rugby Laboratories	8aa81ae9-112a-49fa-a0cb-ed0217a40de5	2026-03-20	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	PERRIGO DIRECT INC.	d3049296-0d15-4523-883c-25f8817bc735	2026-01-15	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Target Corporation	b25106f8-436e-4c06-8780-b12368ede9fe	2025-03-28	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	A-S Medication Solutions	b0eb7b54-4f4e-4ca2-8e4e-30d18d662401	2024-10-01	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Safeway	5fccbb63-7859-484c-b7b3-9de711364c09	2024-05-16	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Cardinal Health	e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8	2023-12-08	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	TOPCO ASSOCIATES LLC	b723daa3-6c6f-4a96-a15d-0d5866f28ca4	2023-12-08	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Kroger Company	eb81286f-72b4-42b3-a596-439d0aeae93f	2023-12-08	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Ketotifen Fumarate	KETOTIFEN FUMARATE	A-S Medication Solutions	1234de19-257c-422c-8706-1239381a2706	2023-05-11	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Alaway	KETOTIFEN FUMARATE	Bausch & Lomb Incorporated	e4c310b5-1dba-4ddc-bc90-b27ebc765871	2022-05-01	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (package): 24208-601-90 ndc (product): 24208-601 ndc11 (package): 24208060190
Equate Eye Itch Relief	KETOTIFEN FUMARATE	Wal-Mart Stores, Inc.	accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9	2021-03-23	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HBD503WORO	KETOTIFEN FUMARATE	34580-14-8	KETOTIFEN FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
707594	Alaway 0.025 % Ophthalmic Solution	PSN	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
707594	ketotifen 0.25 MG/ML Ophthalmic Solution [Alaway]	SBD	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
707594	Alaway 0.025 % Ophthalmic Solution	SY	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
311237	ketotifen 0.025 % Ophthalmic Solution	SY	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	e4c310b5-1dba-4ddc-bc90-b27ebc765871	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-601-90	24208060190	2 BOTTLE, DROPPER in 1 CARTON (24208-601-90) / 10 mL in 1 BOTTLE, DROPPER	2006-12-01	0000-00-00	No	No	Current