FDA.reportPublic FDA data

OLOPATADINE- olopatadine hydrochloride solution/ drops. Drug Facts

Manufacturer
Golden State Medical Supply, Inc. | Akorn
Effective date
2023-08-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:27:11

Label at a glance#

ProductOlopatadine
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

adults and children 2 years of age 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#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)

Purpose

OTC - PURPOSE SECTION

Antihistamine and redness reliever

Use

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 the 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

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience:

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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) 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

OTHER SAFETY INFORMATION

  • only for use in the eye
  • store at 4° to 25°C (39° to 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/or sodium hydroxide (adjust pH), sodium chloride, and water for injection

Questions?

OTC - QUESTIONS SECTION

Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 51407-499-05

Olopatadine HCl Ophthalmic

Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

STERILE 5 mL (0.17 FL OZ)

51407-499-05LB.jpg51407-499-05LB.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 51407-499-05

Prescription

Strength

Olopatadine

HCl Ophthalmic

Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

TWICE DAILY

STERILE

5 mL (0.17 FL OZ)

51407-499-05CB - 10-27-2021.jpg51407-499-05CB - 10-27-2021.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-499-05ML - Milliliter51407-499f1262b9a-2343-457b-a30e-d8097a4e901912021-11-09

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
51407-49951407-499-05

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM

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
A204532-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10

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 22:38:342026-08A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-1084e616aacf4f…
2026-08-18 06:07:402026-07A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-01-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204532-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-01-10f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204532-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204532-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A204532-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204532-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204532-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204532-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A204532-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204532-001AT1ea99ee380514…

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
02fa8d3f-1fc4-041c-e063-6394a90a95accd115efc-8d68-3e01-e053-2a95a90af93c2023-08-15WarningsExact identifier
spl id: 02fa8d3f-1fc4-041c-e063-6394a90a95ac
spl set id: cd115efc-8d68-3e01-e053-2a95a90af93c

Reported adverse events (FAERS/openFDA)#

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