{
  "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": "2026-10-27",
    "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 SORBITOL POLOXAMER 407 SODIUM BENZOATE BENZOIC ACID SACCHARIN SODIUM FD&C GREEN NO. 3"
      ],
      "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"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol (21.6% v/v), sorbitol, poloxamer 407, sodium benzoate, benzoic acid, sodium saccharin, flavor, FD&C green no. 3"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE® COOL MINT®* BLUE MINT ANTISEPTIC MOUTHWASH Antigingivitis/Antiplaque Mouthwash Eucalyptol (0.092%) Menthol (0.042%) Methyl salicylate (0.060%) Thymol (0.064%) Kills 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® Cool Mint®. 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 USA",
        "Package label FAMILY WELLNESS Blue Mint Antiseptic Mouthwash Eucalyptol (0.92%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)"
      ],
      "set_id": "269b9e7f-c5c8-4023-a3ea-e39040ade271",
      "id": "d32a10b2-84f7-45f7-9cf5-0259066bb0ab",
      "effective_time": "20260406",
      "version": "8",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Antiseptic"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
        ],
        "manufacturer_name": [
          "Family Dollar (FAMILY WELLNESS)"
        ],
        "product_ndc": [
          "55319-090"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "d32a10b2-84f7-45f7-9cf5-0259066bb0ab"
        ],
        "spl_set_id": [
          "269b9e7f-c5c8-4023-a3ea-e39040ade271"
        ],
        "package_ndc": [
          "55319-090-01",
          "55319-090-25",
          "55319-090-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0032251740480"
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}