Olopatadine Hydrochloride Ophthalmic Solution

Product NDC: 0363-7131
11-digit product format: 003637131
Labeler code: 0363
Product ID: 0363-7131_bd2944d1-b99e-ec75-1678-fd06e7385727
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine Hydrochloride Ophthalmic
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Walgreens Company
Application: ANDA209752
Marketing category: ANDA
Marketing start: 2020-10-01
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olopatadine Hydrochloride Ophthalmic Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLOPATADINE HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2XG66W44KF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1111343	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
fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1	Product name	3	20210312
ee1438f7-d464-b7de-1b3a-aae378f7d672	Product name	8	20200121
4101b788-a943-3f81-6947-4acf7be2af4d	Product name	4	20190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3ee	Product name	1	20150323
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-7131-25	Olopatadine Hydrochloride Ophthalmic Solution	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5		4
0363-7131-25	Olopatadine Hydrochloride Ophthalmic Solution	1 in 1 CARTON	SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-7131-25	ML - Milliliter	0363-7131	e480a444-23b4-4310-bbfe-83b0fb0dc4d8	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-7131	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [WALGREENS COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20231019_fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7.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 ndc (product): 0363-7131
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111343	olopatadine HCl 0.2 % Ophthalmic Solution	PSN	fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	4
1111343	olopatadine 2 MG/ML Ophthalmic Solution	SCD	fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	4
1111343	olopatadine 0.2 % Ophthalmic Solution	SY	fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	4
1111343	olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic Solution	SY	fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-7131-25	00363713125	1 BOTTLE, PLASTIC in 1 CARTON (0363-7131-25) / 2.5 mL in 1 BOTTLE, PLASTIC	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olopatadine Hydrochloride Ophthalmic Solution - Walgreens Company	Walgreens Company	2025-12-12	Human OTC Drug Label	4