FDA.reportPublic FDA data

Drug Facts

Manufacturer
Apotex Corp.
Effective date
2026-09-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-24 01:01:39

Label at a glance#

ProductOlopatadine hydrochloride
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Dosage and administration

adults and children 2 years and older: put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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 (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

                                 

Purpose

OTC - PURPOSE SECTION

Antihistamine and redness reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itchy and red 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 - ASK DOCTOR 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 a doctor if you experience:

OTC - STOP USE SECTION

  • 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 and older:
    • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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 4ºC to 25ºC (39ºF to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Questions?

OTC - QUESTIONS SECTION

1-800-706-5575

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TWICE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

NDC 60505-6221-0

Bottle LabelBottle Label

Carton LabelCarton Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00360505057511GTIN-14: 00360505057511
GTIN-12: 360505057511
UPC-A: 360505057511
EAN-13: 0360505057511
GTIN storage (14 digits): 00360505057511		Bottle Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60505-622160505-6221-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-09-19full-release2026-06-01 01:14:20

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
A078350-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0784e616aacf4f…
2026-08-18 06:07:402026-07A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078350-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078350-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A078350-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A078350-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078350-001AT1ea99ee380514…

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
ac44fb6f-d383-37f2-9416-6d249604140ecc178825-1a4e-6bca-a00d-aa28d5abe5892025-09-19WarningsExact identifier
spl set id: cc178825-1a4e-6bca-a00d-aa28d5abe589

Reported adverse events (FAERS/openFDA)#

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