Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% TWICE DAILY RELIEF

Manufacturer
Somerset Therapeutics, LLC | Somerset Therapeutics Limited
Effective date
2024-03-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:02

Label at a glance#

ProductOlopatadine
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure9 sections

Storage and handling

Other information only for use in the eye store between 4°-25°C (39°-77°F)

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Drug Facts

Active Ingredients
Purpose
Olopatadine (0.1%)
(equivalent to olopatadine
hydrochloride 0.111%)
Antihistamine and Redness Reliever

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • 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

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

STORAGE AND HANDLING SECTION

Other information

  • only for use in the eye
  • store between 4°-25°C (39°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions?

Customer Care # 1-800-417-9175

SPL UNCLASSIFIED SECTION

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

Code No.:KR/DRUGS/KTK/28/289/97

ST-OLP11-OTC/P/01

1200809

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

 

NDC 70069-017-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%

Antihistamine and Redness Reliever

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

Sterile

5 mL (0.017 FL OZ)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label

 

Original Prescription Strength

NDC 70069-017-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%

Antihistamine and Redness Reliever

TWICE DAILY RELIEF

Eye Allergy Itch & Redness Relief

TWICE DAILY

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

 

Sterile

5 mL (0.017 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN3
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD3
1111339olopatadine 0.1 % Ophthalmic SolutionSY3
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-017-01Olopatadine1 in 1 CARTONSOLUTION/ DROPS13
70069-017-01Olopatadine5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-017OLOPATADINE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]3Current NDC, 2 package rows20240415_55142e80-c5db-46a5-85a5-e8a040bcc8cf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-017-01ML - Milliliter70069-017f25cdcca-b8ba-48ca-93a8-08c9dac9cf9e12024-05-16

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
70069-01770069-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
A206306-001OLOPATADINE 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 22:38:342026-08A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0784e616aacf4f…
2026-08-18 06:07:402026-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206306-001OLOPATADINE 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 UTC2019-12A206306-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206306-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A206306-001AT15aa47cf7b7d7…
2019-12-14 00:12 UTC2019-12A206306-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206306-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206306-001AT1ea99ee380514…

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
OlopatadineOLOPATADINESomerset Therapeutics, LLC55142e80-c5db-46a5-85a5-e8a040bcc8cf2024-03-25WarningsExact identifier
ndc (package): 70069-017-01
ndc (product): 70069-017
ndc11 (package): 70069001701
spl id: 9cb75ee7-d7e0-4f19-8088-05426d8ea407
spl set id: 55142e80-c5db-46a5-85a5-e8a040bcc8cf

Reported adverse events (FAERS/openFDA)#

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