EYE ITCH RELIEF

Product NDC: 0363-0610
11-digit product format: 003630610
Labeler code: 0363
Product ID: 0363-0610_d186b442-7413-4447-b3f1-c3c82fb4e258
Type: HUMAN OTC DRUG
Nonproprietary name: Ketotifen Fumarate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Walgreens
Application: ANDA077958
Marketing category: ANDA
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: KETOTIFEN FUMARATE
Active strength: 0 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0363-0610		I	Inactivated by FDA		2026-08-11
excluded package	package	0363-0610	0363-0610-10	I	Inactivated by FDA		2026-08-11

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0610-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0610-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-0610-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-0610-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-0610-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-0610-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0610-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0610-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0610-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-0610-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-0610-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-0610-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0363-0610-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0363-0610-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0363-0610-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0363-0610-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0363-0610-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0363-0610-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0363-0610-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0363-0610-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0363-0610-10	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077958-001	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC			2007-07-26

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`cb3db0bc1861…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-0610-10	2020-01-31	C162847	48780-1	9d75b9d1-22ef-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-0610-10	EYE ITCH RELIEF	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		3
0363-0610-10	EYE ITCH RELIEF	2 in 1 CARTON	SOLUTION/ DROPS	2		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOTIFEN FUMARATE	ACTIVE INGREDIENT	HBD503WORO	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3
KETOTIFEN	ACTIVE MOIETY	X49220T18G	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0610	EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [WALGREENS]	3	Legacy NDC, 2 package rows	20140926_2bdc00ed-be10-4e1f-b164-3e92dd8f63cd.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Sentiss Pharmaceuticals LLC	7e7be193-63ec-474d-a596-e22fc8b1be0f	2026-04-15	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Preferred Pharmaceuticals Inc.	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2026-03-18	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Eye Itch Relief	KETOTIFEN FUMARATE	CARDINAL HEALTH 110, LLC. DBA LEADER	add414c5-b6c5-4bb5-8d8a-ddc507a27131	2025-09-12	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Armas Pharmaceuticals Inc.	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	2024-01-01	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate	KETOTIFEN FUMARATE	Proficient Rx LP	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	2019-10-01	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958

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	2bdc00ed-be10-4e1f-b164-3e92dd8f63cd	3
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	2bdc00ed-be10-4e1f-b164-3e92dd8f63cd	3
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	2bdc00ed-be10-4e1f-b164-3e92dd8f63cd	3
311237	ketotifen 0.025 % Ophthalmic Solution	SY	2bdc00ed-be10-4e1f-b164-3e92dd8f63cd	3
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	2bdc00ed-be10-4e1f-b164-3e92dd8f63cd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0363-0610-10	00363061010	5 mL in 1 BOTTLE, DROPPER	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Walgreens \| Advanced Vision Research (Subsidiary of Akorn, Inc.) \| Akorn, Inc	2014-09-23	HUMAN OTC DRUG LABEL	3