{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-01",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Equate Olopatadine Hydrochloride Ophthalmic Solution Olopatadine Hydrochloride Ophthalmic Solution BENZALKONIUM CHLORIDE WATER SODIUM HYDROXIDE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM OLOPATADINE HYDROCHLORIDE OLOPATADINE"
      ],
      "active_ingredient": [
        "Active ingredient Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)"
      ],
      "purpose": [
        "Purpose Antihistamine and Redness Reliever"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "spl_unclassified_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 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": [
        "Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "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"
      ],
      "other_safety_information": [
        "Other Information only for use in the eye store between 4-25 °C (39-77 °F) protect from light"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (to adjust pH), sodium chloride and water for injection"
      ],
      "questions": [
        "Questions? Call 1-888-287-1915"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel equate carton"
      ],
      "set_id": "010b0c92-21ad-4e96-ac14-14683131da17",
      "id": "32bfdba1-5dab-787e-e063-6294a90a9602",
      "effective_time": "20250414",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA206046"
        ],
        "brand_name": [
          "Equate Olopatadine Hydrochloride Ophthalmic Solution"
        ],
        "generic_name": [
          "OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION"
        ],
        "manufacturer_name": [
          "WAL-MART STORES, INC.,"
        ],
        "product_ndc": [
          "79903-319"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "OLOPATADINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1111339"
        ],
        "spl_id": [
          "32bfdba1-5dab-787e-e063-6294a90a9602"
        ],
        "spl_set_id": [
          "010b0c92-21ad-4e96-ac14-14683131da17"
        ],
        "package_ndc": [
          "79903-319-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2XG66W44KF"
        ]
      }
    }
  ]
}