Eye Allergy Itch Relief

Product NDC: 62011-0468
Requested package NDC: 62011-0468-1
11-digit product format: 620110468
Labeler code: 62011
Product ID: 62011-0468_16eaefb5-d6d2-783f-d005-d6a9a1b989f4
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine Hydrochloride Ophthalmic
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Strategic Sourcing Specialists, LLC
Application: ANDA209752
Marketing category: ANDA
Marketing start: 2021-03-15
Marketing end: 0000-00-00
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62011-0468	62011-0468-1	D	Discontinued by firm		2026-08-17

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209752-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2020-05-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62011-0468-1	ML - Milliliter	62011-0468	e4817c0d-bdf6-4617-8e0a-44fff9702c07	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0468	EYE ALLERGY ITCH RELIEF (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [STRATEGIC SOURCING SPECIALISTS, LLC]	4	Legacy NDC	20241114_1375f616-7e1d-fb66-cefd-cafa0f9fbb72.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Gland Pharma Limited	9a4c58dc-aee6-441f-8081-608e4fd36193	2026-04-22	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Rugby Laboratories	95424539-7883-2da3-8a46-3d1a19259e15	2026-02-17	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Eye Allergy Itch Relief	OLOPATADINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	135bb2de-b2c0-6f0c-6204-3acbb48dcfbd	2026-02-13	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution Once Daily	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	DOLGENCORP, LLC	fa75f236-0170-e7be-ce8c-7dff7c36fac8	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Allergy Relief Eye Drops	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	CVS Pharmacy	9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e2	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Chain Drug Marketing Association INC	56d4b17c-bc5d-0734-32c9-bb10ec77f7b4	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Eye Allergy Itch Relief Once Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Dr. Reddy's Laboratories Inc.	d9a01be0-218b-b2b9-1cbf-14a9c160ceb2	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Once Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	H E B	0cb0bb66-def2-35d4-7fe0-987757095d08	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Target Corporation	b233bf3d-e6e6-a724-efd9-389b8e36d2f9	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Rite Aid Corporation	e3153a5a-35ca-6c10-eec0-8347c2da121f	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Albertsons Companies	685192af-d729-3066-5825-6d0e03ce787e	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Walgreens Company	fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Dr. Reddy's Laboratories Inc.	f249d79e-0f62-d2f1-bcbc-22dda253aad2	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
CVS Eye Allergy Itch Relief Once Daily	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	CVS Health Corp	fd0e681a-f217-1a97-e9a7-d740816234ff	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Chain Drug Marketing Association INC	f6d70b01-941b-b796-ceee-7f24b6038e7d	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Eye Allergy Itch Relief Once Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Strategic Sourcing Services LLC	ad35e069-72ba-b8df-d6bd-18c0345c80ac	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2XG66W44KF	OLOPATADINE HYDROCHLORIDE	140462-76-6	OLOPATADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62011-0468-1	62011046801	1 BOTTLE, PLASTIC in 1 CARTON (62011-0468-1) > 2.5 mL in 1 BOTTLE, PLASTIC	2021-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eye Allergy Itch Relief - Strategic Sourcing Specialists, LLC	Strategic Sourcing Specialists, LLC	2024-11-12	Human OTC Drug Label	4