FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Manufacturer
TOPCO ASSOCIATES LLC | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2024-06-14
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:13:55

Label at a glance#

ProductOLOPATADINE HYDROCHLORIDE
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure14 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 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

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Olopatadine (0.1%).
(equivalent to olopatadine hydrochloride, USP 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 - 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

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 (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) 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

✆1-855-274-4122

Distributed by:
TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO ARHA0323
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com
 
PRODUCT OF INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCare®             NDC 76162-020-40
       health                 TWICE DAILY
Eye Allergy Itch & Redness Relief
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine & Redness Reliever
 STERILE            0.17 FL OZ (5 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

                                NDC 76162-020-40
+TopCare®
        health
COMPARE TO PATADAY® TWICE DAILY
          RELIEF ACTIVE INGREDIENT*
Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.1%
Eye Allergy Itch
& Redness Relief
Antihistamine & Redness Reliever
Works in Minutes                            
Relief from Allergens:                        
• Pet Dander • Pollen
• Grass • Ragweed
                                                          TWICE
                                                            DAILY
STERILE                       0.17 FL OZ (5 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN2
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD2
1111339olopatadine 0.1 % Ophthalmic SolutionSY2
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY2

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
76162-020-40OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLE, PLASTICSOLUTION52
76162-020-40OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-020OLOPATADINE HYDROCHLORIDE SOLUTION [TOPCO ASSOCIATES LLC]2Current NDC, 2 package rows20240621_f5bddc73-1899-b5f0-e053-2995a90ab98f.zip

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
76162-02076162-020-40

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 HYDROCHLORIDE2XG66W44KFACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
A204812-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18

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 22:38:342026-08A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1884e616aacf4f…
2026-08-18 06:07:402026-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204812-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A204812-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A204812-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204812-001AT1ea99ee380514…

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
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDETOPCO ASSOCIATES LLCf5bddc73-1899-b5f0-e053-2995a90ab98f2024-06-14WarningsExact identifier
ndc (package): 76162-020-40
ndc (product): 76162-020
ndc11 (package): 76162002040
spl id: a413aedd-c114-40a3-bfad-1f9db0565b0f
spl set id: f5bddc73-1899-b5f0-e053-2995a90ab98f

Reported adverse events (FAERS/openFDA)#

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