FDA.reportPublic FDA data

Eye Allergy Itch Relief

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2026-02-13
Label type
Human OTC Drug Label
Version
8
Source
full-release
Hydrated at
2026-06-01 01:51:56

Label at a glance#

ProductEye Allergy Itch Relief
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure15 sections

Dosage and administration

adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily, no more than once per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use    children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE

INDICATIONS & USAGE SECTION

temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy  
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • do not wear a contact lens if your eye is red

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

you experience:  

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) once daily, no more than once per day
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • replace cap after each use   
  • children under 2 years of age: consult a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• only for use in the eye  
• store between 2° to 25°C (36° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Edetate disodium, Hydrochloric acid/Sodium hydroxide (adjust pH), Povidone, Sodium chloride, and Water for Injection.

QUESTIONS?

SPL UNCLASSIFIED SECTION

Call 1-888-375-3784

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in India

Code: AP/DRUGS/103/97

Rev. 11/25

CIN 5659222

©2025 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

*This product is not manufactured or distributed by Alcon Laboratories Inc., distributor of Pataday® Once Daily Relief. Pataday® is a registered trademark of Novartis AG.

100% Money Back Guarantee

Return to place of purchase if not satisfied.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label:

NDC 70000-0053-1

Original Prescription Strength

Eye Allergy Itch Relief

Olopatadine HCl Opthalmic Solution USP, 0.2%

Antihistamine

Once Daily Relief

Works in Minutes

Once Daily

Sterile

2.5 mL (0.085 fl oz)

For Ages 2 and Older

30 DAY SUPPLY

TAMPER EVIDENT: Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

COMPARE TO PATADAY® ONCE DAILY RELIEF active ingredient*

Carton
Carton

Container Label:

NDC 70000-0053-1

Eye Allergy Itch Relief

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Sterile

2.5 mL (0.085 fl oz)

Container
Container

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN8
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD8
1111343olopatadine 0.2 % Ophthalmic SolutionSY8
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OLOPATADINE Pharmacologic Class Indexing4Indexing - Pharmacologic Class20220128

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0053-1Eye Allergy Itch Relief1 in 1 CARTONSOLUTION/ DROPS18
70000-0053-1Eye Allergy Itch Relief2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0053-1ML - Milliliter70000-0053acacbad5-1072-4599-9259-acfd969baf1512021-05-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-005370000-0053-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
POVIDONE K30U725QWY32XIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-12-12monthly-update2026-06-03 17:45:52

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209752-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2084e616aacf4f…
2026-08-18 06:07:402026-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Allergy Itch ReliefOLOPATADINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER135bb2de-b2c0-6f0c-6204-3acbb48dcfbd2026-02-13WarningsExact identifier
ndc (package): 70000-0053-1
ndc (product): 70000-0053
ndc11 (package): 70000005301
spl id: ece56087-7def-0eb9-13d3-b187763b7f7b
spl set id: 135bb2de-b2c0-6f0c-6204-3acbb48dcfbd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.