FDA.reportPublic FDA data

olopatadine version 2 auro

Manufacturer
YYBA CORP
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-15 03:01:05

Label at a glance#

ProductOLOPATADINE HYDROCHLORIDE
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure13 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 opthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use childrent under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Use 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 reinsterting contact lenses after use
  • do not wear a contact lens if your eye is red

Stop use and ask a doctor if:

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 (1-800-222-1222) 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 opthalmic products while using this product, wait at least 5 minutes between each product
  • replace cap after each use
  • childrent under 2 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • only for use in the eye
  • store between 2 degrees to 25 degrees celsius (36 degrees to 77 degrees farenheit)

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?

OTC - QUESTIONS SECTION

1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373581000876GTIN-13: 0373581000876
EAN-13: 0373581000876
GTIN-12: 373581000876
UPC-A: 373581000876
GTIN storage (14 digits): 00373581000876		cartonauro.jpg

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73581-71373581-713-02

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 HYDROCHLORIDE2XG66W44KFACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONEFZ989GH94EIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
A209995-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04

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 22:38:342026-08A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0484e616aacf4f…
2026-08-18 06:07:402026-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-043f01610625f2…
2019-09-15 20:21 UTC2019-09A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209995-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A209995-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A209995-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209995-001AT1ea99ee380514…

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 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine HydrochlorideOLOPATADINE HYDROCHLORIDEYYBA CORP598156e4-f183-86f5-e063-6294a90a64df2026-08-20WarningsName fallback
brand name: Olopatadine Hydrochloride
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE OPHTHALMICGolden State Medical Supply, Inc.50b02d58-dd82-6d0a-e063-6294a90a28fd2026-04-30WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESportpharm LLCf0cc699c-545d-4097-b85d-b67ba550863c2026-04-24WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Retaine AllergyOLOPATADINE HYDROCHLORIDEOCuSOFT LLCe0a01606-275d-448c-8838-ca46f1e612e52026-04-23WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBest Choice04c7b08c-52c1-427c-8b8f-fe67444fbca42026-04-22WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.5295f8a2-4e0d-4b6e-9807-e2f36b1d5d152026-04-15WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBluePoint Laboratories3e86783f-0001-625f-e063-6294a90acd202026-03-25WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESomerset Therapeutics, LLC6ee9f8f5-973c-4c71-8069-e76cd87b07dc2026-03-25WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5d79fc06-a25f-debb-f08b-523ff26df9002026-02-24WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine HydrochlorideOLOPATADINE HYDROCHLORIDERugby Laboratories95424539-7883-2da3-8a46-3d1a19259e152026-02-17WarningsName fallback
brand name: Olopatadine Hydrochloride
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisourceBergen Drug Corp18f851e3-24c6-44fd-8376-0f5418ded9a92026-02-16WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE OPHTHALMICAmerisourceBergen Drug Corpea97d3d8-dc96-4c40-91e7-f076c588bf122026-02-16WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch and Redness ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5255d142-7d04-ab80-fa97-b11c4486e42c2026-02-13WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEYYBA Corp47f8ae9b-d92b-4bcb-e063-6294a90af45a2026-02-03WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDETARGET CORPORATIONaa112cbd-35c0-a723-48cc-21137332b2c32026-02-03WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEGLENMARK THERAPEUTICS INC., USA07e8b359-d4ae-4b5b-81dc-c7e57e172c582026-01-27WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE OPHTHALMICGLENMARK THERAPEUTICS INC., USAa80c3fd2-47b7-4ed0-b862-9c50996846072026-01-27WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
Olopatadine HClOLOPATADINE HYDROCHLORIDERugby Laboratoriesedb068e2-1835-483e-e59c-bcbe13b66d762026-01-22WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.1c7d2342-ba1c-4244-9814-d92a05725d4e2026-01-20WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.b7a24375-25df-4405-aa7c-34c46af511942026-01-20WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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