OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION

Manufacturer
Cipla USA Inc. | Cipla Ltd. Indore
Effective date
2021-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:55

Label at a glance#

ProductOlopatadine Hydrochloride
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

Warnings - 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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

KEEP OUT OF REACH OF CHILDREN

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.

DIRECTION

DOSAGE & ADMINISTRATION SECTION

●  adults and children 2 years of age and older:

o              put 1 drop in the affected eye(s) once daily, no more than once per day

o              if using other ophthalmic products while using this product, wait at least 5 minutes between each product

o              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°-25°C (36°-77°F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, purified water, and sodium chloride

Questions

SPL UNCLASSIFIED SECTION

Call 1-866-604-3268

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription

Strength

NDC 69097-600-33

Olopatadine

Hydrochloride

Ophthalmic

 Solution, USP 0.2%

Antihistamine

ONCE DAILY

Eye allergy itch relief

Works in Minutes

Relief from Allergens:

   ● Pet Dander

   ● Pollen

● Grass

●Ragweed

Cipla

STERILE

2.5 mL (0.085 FL OZ)

carton
carton

NDC 69097-600-33

Olopatadine

Hydrochloride

Ophthalmic Solution,

USP, 0.2%

Once Daily

Antihistamine

Eye Allergy Itch Relief

Sterile 2.5 mL (0.085 FL OZ)

vial
vial

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-600OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [CIPLA USA INC.]2Legacy NDC20211203_172dbf94-d618-42fe-9cb8-552e0e0625f2.zip

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
69097-60069097-600-33

Ingredients#

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

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

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
A206087-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05

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 22:38:342026-08A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-0584e616aacf4f…
2026-08-18 06:07:402026-07A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2017-12-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2017-12-053f01610625f2…
2019-09-15 20:21 UTC2019-09A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2017-12-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2017-12-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A206087-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A206087-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206087-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206087-001AT1ea99ee380514…

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
30bc22e2-ebe7-42b9-a683-ea2286b21df7172dbf94-d618-42fe-9cb8-552e0e0625f22025-12-15WarningsExact identifier
spl set id: 172dbf94-d618-42fe-9cb8-552e0e0625f2

Reported adverse events (FAERS/openFDA)#

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