{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Listerine FreshBurst Antiseptic Eucalyptol, MENTHOL, UNSPECIFIED FORM, Methyl Salicylate, and Thymol WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE D&C YELLOW NO. 10 FD&C GREEN NO. 3 EUCALYPTOL EUCALYPTOL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
      ],
      "active_ingredient": [
        "Active ingredients Purposes Eucalyptol (0.092%) Antiplaque/antigingivitis Menthol (0.042%) Antiplaque/antigingivitis Methyl Salicylate (0.060%) Antiplaque/antigingivitis Thymol (0.064%) Antiplaque/antigingivitis"
      ],
      "active_ingredient_table": [
        "<table width=\"60%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"left\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purposes</content></th></tr></thead><tbody><tr><td>Eucalyptol (0.092%)</td><td>Antiplaque/antigingivitis</td></tr><tr><td>Menthol (0.042%)</td><td>Antiplaque/antigingivitis</td></tr><tr><td>Methyl Salicylate (0.060%)</td><td>Antiplaque/antigingivitis</td></tr><tr><td>Thymol (0.064%)</td><td>Antiplaque/antigingivitis</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purposes Eucalyptol (0.092%) Antiplaque/antigingivitis Menthol (0.042%) Antiplaque/antigingivitis Methyl Salicylate (0.060%) Antiplaque/antigingivitis Thymol (0.064%) Antiplaque/antigingivitis"
      ],
      "purpose_table": [
        "<table width=\"60%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"left\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purposes</content></th></tr></thead><tbody><tr><td>Eucalyptol (0.092%)</td><td>Antiplaque/antigingivitis</td></tr><tr><td>Menthol (0.042%)</td><td>Antiplaque/antigingivitis</td></tr><tr><td>Methyl Salicylate (0.060%)</td><td>Antiplaque/antigingivitis</td></tr><tr><td>Thymol (0.064%)</td><td>Antiplaque/antigingivitis</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses helps prevent and reduce: plaque gingivitis"
      ],
      "warnings": [
        "Warnings Do not use in children under 12 years of age Ask a dentist if symptoms persist Ask a dentist if symptoms persist , new symptoms appear, or conditions worsen after regular use Keep out of reach of children. ​Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in children under 12 years of age"
      ],
      "ask_doctor": [
        "Ask a dentist if symptoms persist Ask a dentist if symptoms persist , new symptoms appear, or conditions worsen after regular use"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. ​Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night do not swallow"
      ],
      "storage_and_handling": [
        "Other information this rinse is not intended to replace brushing or flossing store at room temperature cold weather may cloud this product. Its antiseptic properties are not affected."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, Green 3"
      ],
      "questions": [
        "Questions? call toll-free 888-222-0182 or 215-273-8755 (collect)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label ANTISEPTIC LISTERINE ® FRESHBURST ® FOR A FRESHER & CLEANER MOUTH THAN BRUSHING ALONE ADA Accepted American Dental Association ® 1.5 L (1 Qt 1 Pt 2.7 fl oz) Listerine_001"
      ],
      "set_id": "62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8",
      "id": "22634de5-9318-1b56-e063-6394a90a6245",
      "effective_time": "20241111",
      "version": "9",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Listerine FreshBurst Antiseptic"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0239"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL, UNSPECIFIED FORM",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619",
          "1043623"
        ],
        "spl_id": [
          "22634de5-9318-1b56-e063-6394a90a6245"
        ],
        "spl_set_id": [
          "62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8"
        ],
        "package_ndc": [
          "69968-0239-5",
          "69968-0239-2",
          "69968-0239-1",
          "69968-0239-3",
          "69968-0239-8"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0312547428552"
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}