Eye Itch Relief

Product NDC: 0363-0038
Requested package NDC: 0363-0038-10
11-digit product format: 003630038
Labeler code: 0363
Product ID: 0363-0038_4ddfb3f8-812d-c7c4-e063-6394a90a284d
Type: HUMAN OTC DRUG
Nonproprietary name: ketotifen fumarate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Walgreen Company
Application: NDA021996
Marketing category: NDA
Marketing start: 2013-09-03
Substance: KETOTIFEN FUMARATE
Active strength: .35 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: Eye Itch Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOTIFEN FUMARATE	.35 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311237	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
9ce8f926-c202-40d1-9dba-0477f1f49e14	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
0363-0038-05	Eye Itch Relief	1 in 1 CARTON	SOLUTION	1	9
0363-0038-05	Eye Itch Relief	5 mL in 1 BOTTLE	SOLUTION	5	9
0363-0038-10	Eye Itch Relief	1 in 1 CARTON	SOLUTION	1	9
0363-0038-10	Eye Itch Relief	10 mL in 1 BOTTLE	SOLUTION	10	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0038	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [WALGREEN COMPANY]	7	Current NDC, Legacy NDC, 4 package rows	20240322_9ce8f926-c202-40d1-9dba-0477f1f49e14.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 · 15 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 ndc (package): 0363-0038-10 ndc (product): 0363-0038 ndc11 (package): 00363003810
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 Releif	KETOTIFEN FUMARATE	Rite Aid Corporation	6a7be1e9-27ff-44d8-85ed-fc1b0017180e	2024-07-22	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
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
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	9ce8f926-c202-40d1-9dba-0477f1f49e14	9
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	9ce8f926-c202-40d1-9dba-0477f1f49e14	9
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	9ce8f926-c202-40d1-9dba-0477f1f49e14	9
311237	ketotifen 0.025 % Ophthalmic Solution	SY	9ce8f926-c202-40d1-9dba-0477f1f49e14	9
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	9ce8f926-c202-40d1-9dba-0477f1f49e14	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0038-10	00363003810	1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE	1 bottle	2013-09-03	0000-00-00	No	No	Current