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OLOPATADINE HYDROCHLORIDE
Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
OLOPATADINE HYDROCHLORIDE
Generic name
Olopatadine Hydrochloride
Dosage form
Solution
Route
Ophthalmic
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
46
Packages
56
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Solution
Route of administration
Ophthalmic
Presentations
102
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Histamine Release [PE] | PE | All 16 members |
| Histamine H1 Receptor Antagonists [MoA] | MoA | All 136 members |
| Histamine-1 Receptor Antagonist [EPC] | EPC | All 134 members |
| Histamine-1 Receptor Inhibitor [EPC] | EPC | All 19 members |
| Mast Cell Stabilizer [EPC] | EPC | All 16 members |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
209995
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 4, 2019
Sponsor
EUGIA PHARMA
Products on application
1
Submissions recorded
2
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 209995-001 | OLOPATADINE HYDROCHLORIDE | SOLUTION/DROPS | OLOPATADINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 1 | Labeling | Approved | July 15, 2020 | Standard |
| Original application | 1 | Approved | April 4, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260820). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260820 HUMAN OTC DRUG · 20260203 HUMAN OTC DRUG · 20260127 HUMAN OTC DRUG · 20251216
Indications and Usage
openFDA Drug LabelingUSE(S) temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
Purpose
openFDA Drug LabelingActive Ingredient Purpose Olopatadine (0.1%). (equivalent to olopatadine hydrochloride 0.111%) Antihistamine and redness reliever
Dosage and Administration
openFDA Drug LabelingDirections 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 only for use in the eye store between 4-25 °C (39-77 °F) protect from light
Warnings
openFDA Drug LabelingWarnings For external use only 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 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
Do Not Use
openFDA Drug LabelingDo 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
Stop Use
openFDA Drug LabelingStop use and ask a doctor if you experience: Stop use and ask a doctor if: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours
Active Ingredient
openFDA Drug LabelingActive Ingredients - Purpose - Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-5613 NDC: 50090-5613-0 2.5 mL in a BOTTLE, PLASTIC / 1 in a CARTON
Adverse event reports
Source: openFDA FAERS7,693
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: OLOPATADINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-5613-0 | 50090-5613 | A-S Medication Solutions | 1 BOTTLE, PLASTIC in 1 CARTON (50090-5613-0) / 2.5 mL in 1 BOTTLE, PLASTIC | August 13, 2021 |
| 50090-6341-0 | 50090-6341 | A-S Medication Solutions | 1 BOTTLE, PLASTIC in 1 CARTON (50090-6341-0) / 5 mL in 1 BOTTLE, PLASTIC | January 20, 2023 |
| 80539-001-39 | 80539-001 | Allwell Health Inc | 1 BOTTLE, PLASTIC in 1 CARTON (80539-001-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 46122-671-27 | 46122-671 | Amerisource Bergen | 1 BOTTLE, PLASTIC in 1 CARTON (46122-671-27) / 2.5 mL in 1 BOTTLE, PLASTIC | January 19, 2021 |
| 46122-672-64 | 46122-672 | Amerisource Bergen | 1 BOTTLE, PLASTIC in 1 CARTON (46122-672-64) / 5 mL in 1 BOTTLE, PLASTIC | January 20, 2021 |
| 46122-823-29 | 46122-823 | AmerisourceBergen Drug Corp | 1 BOTTLE, PLASTIC in 1 CARTON (46122-823-29) / 5 mL in 1 BOTTLE, PLASTIC | May 1, 2026 |
| 46122-824-29 | 46122-824 | AmerisourceBergen Drug Corp | 1 BOTTLE, PLASTIC in 1 CARTON (46122-824-29) / 2.5 mL in 1 BOTTLE, PLASTIC | May 1, 2026 |
| 58602-006-40 | 58602-006 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-006-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-007-39 | 58602-007 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-007-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-007-41 | 58602-007 | Aurohealth LLC | 2 BOTTLE, PLASTIC in 1 CARTON (58602-007-41) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-009-40 | 58602-009 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-009-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-010-39 | 58602-010 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-010-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-010-41 | 58602-010 | Aurohealth LLC | 2 BOTTLE, PLASTIC in 1 CARTON (58602-010-41) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-012-40 | 58602-012 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-012-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-013-39 | 58602-013 | Aurohealth LLC | 1 BOTTLE, PLASTIC in 1 CARTON (58602-013-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 58602-013-41 | 58602-013 | Aurohealth LLC | 2 BOTTLE, PLASTIC in 1 CARTON (58602-013-41) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 24208-617-01 | 24208-617 | Bausch & Lomb Incorporated | 1 BOTTLE, PLASTIC in 1 CARTON (24208-617-01) / 3.5 mL in 1 BOTTLE, PLASTIC | January 20, 2025 |
| 24208-967-01 | 24208-967 | Bausch & Lomb Incorporated | 1 BOTTLE, PLASTIC in 1 CARTON (24208-967-01) / 3.5 mL in 1 BOTTLE, PLASTIC | January 20, 2025 |
| 24208-967-02 | 24208-967 | Bausch & Lomb Incorporated | 2 BOTTLE, PLASTIC in 1 CARTON (24208-967-02) / 3.5 mL in 1 BOTTLE, PLASTIC | January 20, 2025 |
| 24208-967-03 | 24208-967 | Bausch & Lomb Incorporated | 3 BOTTLE, PLASTIC in 1 CARTON (24208-967-03) / 3.5 mL in 1 BOTTLE, PLASTIC | January 20, 2025 |
| 63941-024-39 | 63941-024 | Best Choice | 1 BOTTLE, PLASTIC in 1 CARTON (63941-024-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 68001-530-69 | 68001-530 | BluePoint Laboratories | 1 BOTTLE, PLASTIC in 1 CARTON (68001-530-69) / 2.5 mL in 1 BOTTLE, PLASTIC | April 8, 2022 |
| 68001-674-92 | 68001-674 | BluePoint Laboratories | 1 BOTTLE, PLASTIC in 1 CARTON (68001-674-92) / 2.5 mL in 1 BOTTLE, PLASTIC | December 5, 2025 |
| 72657-168-50 | 72657-168 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE, PLASTIC in 1 CARTON (72657-168-50) / 5 mL in 1 BOTTLE, PLASTIC | July 26, 2024 |
| 72657-194-11 | 72657-194 | GLENMARK THERAPEUTICS INC., USA | 2 BOTTLE, PLASTIC in 1 CARTON (72657-194-11) / 2.5 mL in 1 BOTTLE, PLASTIC | February 28, 2025 |
| 72657-194-25 | 72657-194 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE, PLASTIC in 1 CARTON (72657-194-25) / 2.5 mL in 1 BOTTLE, PLASTIC | February 28, 2025 |
| 51407-938-05 | 51407-938 | Golden State Medical Supply, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (51407-938-05) / 5 mL in 1 BOTTLE, PLASTIC | March 3, 2026 |
| 72036-008-40 | 72036-008 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-008-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 72036-009-39 | 72036-009 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-009-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 30142-026-27 | 30142-026 | Kroger Company | 1 BOTTLE, PLASTIC in 1 CARTON (30142-026-27) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 30142-064-64 | 30142-064 | Kroger Company | 1 BOTTLE, PLASTIC in 1 CARTON (30142-064-64) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 79481-1000-1 | 79481-1000 | Meijer | 1 BOTTLE, PLASTIC in 1 CARTON (79481-1000-1) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 79481-1001-2 | 79481-1001 | Meijer | 1 BOTTLE, PLASTIC in 1 CARTON (79481-1001-2) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 79481-1001-4 | 79481-1001 | Meijer | 2 BOTTLE, PLASTIC in 1 CARTON (79481-1001-4) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 11822-0063-2 | 11822-0063 | RITE AID CORPORATION | 1 BOTTLE, PLASTIC in 1 CARTON (11822-0063-2) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 11822-0064-1 | 11822-0064 | RITE AID CORPORATION | 1 BOTTLE, PLASTIC in 1 CARTON (11822-0064-1) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 72476-851-21 | 72476-851 | Retail Business Services, LLC. | 1 BOTTLE, PLASTIC in 1 CARTON (72476-851-21) / 2.5 mL in 1 BOTTLE, PLASTIC | April 2, 2021 |
| 72476-852-64 | 72476-852 | Retail Business Services, LLC. | 1 BOTTLE, PLASTIC in 1 CARTON (72476-852-64) / 5 mL in 1 BOTTLE, PLASTIC | May 6, 2021 |
| 16571-861-25 | 16571-861 | Rising Pharma Holdings, Inc. | 1 CONTAINER in 1 CARTON (16571-861-25) / 2.5 mL in 1 CONTAINER | May 1, 2025 |
| 16571-882-05 | 16571-882 | Rising Pharma Holdings, Inc. | 1 CONTAINER in 1 CARTON (16571-882-05) / 5 mL in 1 CONTAINER | May 1, 2025 |
| 85766-111-05 | 85766-111 | Sportpharm LLC | 1 BOTTLE, PLASTIC in 1 CARTON (85766-111-05) / 5 mL in 1 BOTTLE, PLASTIC | November 10, 2025 |
| 70677-1280-1 | 70677-1280 | Strategic Sourcing Services LLC | 1 BOTTLE, PLASTIC in 1 CARTON (70677-1280-1) / 5 mL in 1 BOTTLE, PLASTIC | March 1, 2025 |
| 82442-966-01 | 82442-966 | TARGET CORPORATION | 1 BOTTLE in 1 CARTON (82442-966-01) / 5 mL in 1 BOTTLE | April 15, 2025 |
| 76162-020-40 | 76162-020 | TOPCO ASSOCIATES LLC | 1 BOTTLE, PLASTIC in 1 CARTON (76162-020-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 76162-044-39 | 76162-044 | TOPCO ASSOCIATES LLC | 1 BOTTLE, PLASTIC in 1 CARTON (76162-044-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 0363-0200-40 | 0363-0200 | WALGREEN CO. | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 0363-8022-39 | 0363-8022 | WALGREEN CO. | 1 BOTTLE, PLASTIC in 1 CARTON (0363-8022-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 0363-8022-41 | 0363-8022 | WALGREEN CO. | 2 BOTTLE, PLASTIC in 1 CARTON (0363-8022-41) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 0363-0869-01 | 0363-0869 | WALGREEN COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0869-01) / 3.5 mL in 1 BOTTLE, PLASTIC | December 22, 2025 |
| 0363-0869-02 | 0363-0869 | WALGREEN COMPANY | 2 BOTTLE, PLASTIC in 1 CARTON (0363-0869-02) / 3.5 mL in 1 BOTTLE, PLASTIC | December 22, 2025 |
| 79903-000-40 | 79903-000 | Wal-Mart Stores, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (79903-000-40) / 5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 79903-001-39 | 79903-001 | Wal-Mart Stores, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (79903-001-39) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 79903-001-41 | 79903-001 | Wal-Mart Stores, Inc. | 2 BOTTLE, PLASTIC in 1 CARTON (79903-001-41) / 2.5 mL in 1 BOTTLE, PLASTIC | July 15, 2020 |
| 73581-712-02 | 73581-712 | YYBA CORP | 2 BOTTLE in 1 CARTON (73581-712-02) / 2.5 mL in 1 BOTTLE | August 31, 2026 |
| 73581-713-02 | 73581-713 | YYBA CORP | 2 BOTTLE in 1 CARTON (73581-713-02) / 2.5 mL in 1 BOTTLE | September 10, 2026 |
| 73581-709-02 | 73581-709 | YYBA Corp | 2 BOTTLE in 1 CARTON (73581-709-02) / 2.5 mL in 1 BOTTLE | March 1, 2026 |
| 50090-5613 | 50090-5613 | A-S Medication Solutions | — | July 15, 2020 |
| 50090-6341 | 50090-6341 | A-S Medication Solutions | — | July 15, 2020 |
| 80539-001 | 80539-001 | Allwell Health Inc | — | July 15, 2020 |
| 46122-671 | 46122-671 | Amerisource Bergen | — | January 19, 2021 |
| 46122-672 | 46122-672 | Amerisource Bergen | — | January 20, 2021 |
| 46122-823 | 46122-823 | AmerisourceBergen Drug Corp | — | May 1, 2026 |
| 46122-824 | 46122-824 | AmerisourceBergen Drug Corp | — | May 1, 2026 |
| 58602-006 | 58602-006 | Aurohealth LLC | — | July 15, 2020 |
| 58602-007 | 58602-007 | Aurohealth LLC | — | July 15, 2020 |
| 58602-009 | 58602-009 | Aurohealth LLC | — | July 15, 2020 |
| 58602-010 | 58602-010 | Aurohealth LLC | — | July 15, 2020 |
| 58602-012 | 58602-012 | Aurohealth LLC | — | July 15, 2020 |
| 58602-013 | 58602-013 | Aurohealth LLC | — | July 15, 2020 |
| 24208-617 | 24208-617 | Bausch & Lomb Incorporated | — | January 20, 2025 |
| 24208-967 | 24208-967 | Bausch & Lomb Incorporated | — | January 20, 2025 |
| 63941-024 | 63941-024 | Best Choice | — | July 15, 2020 |
| 68001-530 | 68001-530 | BluePoint Laboratories | — | April 8, 2022 |
| 68001-674 | 68001-674 | BluePoint Laboratories | — | December 5, 2025 |
| 72657-168 | 72657-168 | GLENMARK THERAPEUTICS INC., USA | — | July 26, 2024 |
| 72657-194 | 72657-194 | GLENMARK THERAPEUTICS INC., USA | — | February 28, 2025 |
| 51407-938 | 51407-938 | Golden State Medical Supply, Inc. | — | June 28, 2017 |
| 72036-008 | 72036-008 | Harris Teeter | — | July 15, 2020 |
| 72036-009 | 72036-009 | Harris Teeter | — | July 15, 2020 |
| 30142-026 | 30142-026 | Kroger Company | — | July 15, 2020 |
| 30142-064 | 30142-064 | Kroger Company | — | July 15, 2020 |
| 79481-1000 | 79481-1000 | Meijer | — | July 15, 2020 |
| 79481-1001 | 79481-1001 | Meijer | — | July 15, 2020 |
| 11822-0063 | 11822-0063 | RITE AID CORPORATION | — | July 15, 2020 |
| 11822-0064 | 11822-0064 | RITE AID CORPORATION | — | July 15, 2020 |
| 72476-851 | 72476-851 | Retail Business Services, LLC. | — | April 2, 2021 |
| 72476-852 | 72476-852 | Retail Business Services, LLC. | — | May 6, 2021 |
| 16571-861 | 16571-861 | Rising Pharma Holdings, Inc. | — | May 1, 2025 |
| 16571-882 | 16571-882 | Rising Pharma Holdings, Inc. | — | May 1, 2025 |
| 85766-111 | 85766-111 | Sportpharm LLC | — | July 15, 2020 |
| 70677-1280 | 70677-1280 | Strategic Sourcing Services LLC | — | March 1, 2025 |
| 82442-966 | 82442-966 | TARGET CORPORATION | — | April 15, 2025 |
| 76162-020 | 76162-020 | TOPCO ASSOCIATES LLC | — | July 15, 2020 |
| 76162-044 | 76162-044 | TOPCO ASSOCIATES LLC | — | July 15, 2020 |
| 0363-0200 | 0363-0200 | WALGREEN CO. | — | July 15, 2020 |
| 0363-8022 | 0363-8022 | WALGREEN CO. | — | July 15, 2020 |
| 0363-0869 | 0363-0869 | WALGREEN COMPANY | — | December 22, 2025 |
| 79903-000 | 79903-000 | Wal-Mart Stores, Inc. | — | July 15, 2020 |
| 79903-001 | 79903-001 | Wal-Mart Stores, Inc. | — | July 15, 2020 |
| 73581-712 | 73581-712 | YYBA CORP | — | August 31, 2026 |
| 73581-713 | 73581-713 | YYBA CORP | — | September 10, 2026 |
| 73581-709 | 73581-709 | YYBA Corp | — | March 1, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.