OLOPATADINE HYDROCHLORIDE

Product NDC: 11822-0064
11-digit product format: 118220064
Labeler code: 11822
Product ID: 11822-0064_6671f033-5ae9-4fc5-9eef-dbecf0c1fb95
Type: HUMAN OTC DRUG
Nonproprietary name: OLOPATADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: RITE AID CORPORATION
Application: ANDA204812
Marketing category: ANDA
Marketing start: 2020-07-15
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 1 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 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
A204812-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2015-12-18

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204812-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204812-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204812-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204812-001	AT	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: OLOPATADINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLOPATADINE HYDROCHLORIDE	1 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
1111339	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
1ce23269-9678-58be-e063-6294a90aa1d3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1	Product name	3	20210312
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
ee1438f7-d464-b7de-1b3a-aae378f7d672	Product name	8	20200121
4101b788-a943-3f81-6947-4acf7be2af4d	Product name	4	20190703
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
ca2d4a1a-2b5b-4256-9aad-735e9282b3ee	Product name	1	20150323
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-0064-1	OLOPATADINE HYDROCHLORIDE	1 in 1 CARTON	SOLUTION	1		2
11822-0064-1	OLOPATADINE HYDROCHLORIDE	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0064	OLOPATADINE HYDROCHLORIDE SOLUTION [RITE AID CORPORATION]	2	Current NDC, 2 package rows	20241025_1ce23269-9678-58be-e063-6294a90aa1d3.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
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Sportpharm LLC	f0cc699c-545d-4097-b85d-b67ba550863c	2026-04-24	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	94b1fe3b-6a9b-475a-9c65-1700ce1c2183	2025-10-09	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce23269-9678-58be-e063-6294a90aa1d3	2024-10-22	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812 ndc (product): 11822-0064
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f5bddc73-1899-b5f0-e053-2995a90ab98f	2024-06-14	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	f3b054d2-4abd-4a1f-910d-0c61e2a24fbf	2023-07-10	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	c4ad0d8e-7539-4dc8-825d-d5e9ff27e488	2023-02-02	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	09dda927-4191-425c-936c-1acbf94ef657	2022-09-03	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	06467360-22fe-4a48-b234-06dbff30e853	2022-06-21	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	637cb721-53bf-4938-80a6-5760980098eb	2021-11-11	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b631055d-c279-215f-e053-2a95a90a8c9c	2021-09-30	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bd2deb79-c135-2d3f-e053-2a95a90a9322	2021-05-07	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	f8993bc2-0fb3-4802-8187-3677d0e58026	2021-01-28	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	c12af544-995a-43d7-8404-94906d52fa07	2020-08-28	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	8fb16daa-340d-45a0-ab22-e028d77e2476	2020-08-21	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812

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
1111339	olopatadine HCl 0.1 % Ophthalmic Solution	PSN	1ce23269-9678-58be-e063-6294a90aa1d3	2
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	1ce23269-9678-58be-e063-6294a90aa1d3	2
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	1ce23269-9678-58be-e063-6294a90aa1d3	2
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	1ce23269-9678-58be-e063-6294a90aa1d3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
11822-0064-1	11822006401	1 BOTTLE, PLASTIC in 1 CARTON (11822-0064-1) / 5 mL in 1 BOTTLE, PLASTIC	2020-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLOPATADINE - RITE AID CORPORATION \| EUGIA PHARMA SPECIALITIES LIMITED	RITE AID CORPORATION \| EUGIA PHARMA SPECIALITIES LIMITED	2024-10-22	Human OTC Drug Label	2