{
  "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": "2026-10-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL POLOXAMER 407 BENZOIC ACID SODIUM BENZOATE CARAMEL Clear"
      ],
      "active_ingredient": [
        "Active ingredient Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)"
      ],
      "purpose": [
        "Purposes Antiplaque/antigingivitis"
      ],
      "indications_and_usage": [
        "Uses helps prevent and reduce plaque gingivitis"
      ],
      "warnings": [
        "Warning Do not use in children under 12 years of age. Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use in children under 12 years of age."
      ],
      "stop_use": [
        "Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use"
      ],
      "other_safety_information": [
        "Other information store at room temperature cold weather may cloud this product. Its antiseptic properties are not affected. this rinse is nor intended to replace brushing or flossing"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol (26.9% v/v), poloxamer 407, sodium benzoate, benzoic acid, caramel"
      ],
      "questions": [
        "Questions or comments Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE®* ORIGINAL ANTISEPTIC MOUTHWASH Antigingivitis/Antiplaque Mouthwash Eucalyptol (0.092%) Menthol (0.042%) Methyl salicylate (0.060%) Thymol (0.064%) Kill germs that cause plaque, gingivitis, bad breath Helps to control and prevent plaque that leads to gingivitis mL (fl oz) *This product is not manufactured or distributed by Kenvue Brands LLC, distributor of Listerine®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 510 VOLVO PKWY, CHESAPEAKE, VA 23320",
        "Package label FAMILY WELLNESS Original Mouthwash Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)"
      ],
      "set_id": "9f991292-bbaa-4f4e-b2cb-059d1a04849e",
      "id": "538277bd-6e12-40c3-af57-c1c6891a1a56",
      "effective_time": "20260420",
      "version": "9",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Antiseptic"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
        ],
        "manufacturer_name": [
          "Family Dollar (FAMILY WELLNESS)"
        ],
        "product_ndc": [
          "55319-089"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "538277bd-6e12-40c3-af57-c1c6891a1a56"
        ],
        "spl_set_id": [
          "9f991292-bbaa-4f4e-b2cb-059d1a04849e"
        ],
        "package_ndc": [
          "55319-089-01",
          "55319-089-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0032251741104"
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}