{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Antiseptic Mouthrinse Eucalyptol, Menthol, Methyl Salicylate, Thymol WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM CITRATE D&C YELLOW NO. 10 FD&C GREEN NO. 3 EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL"
      ],
      "active_ingredient": [
        "Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%"
      ],
      "purpose": [
        "Purpose Antigingivitis, Antiplaque"
      ],
      "indications_and_usage": [
        "Use helps control plaque that leads to gingivitis"
      ],
      "warnings": [
        "Warnings for this product"
      ],
      "do_not_use": [
        "Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease."
      ],
      "stop_use": [
        "Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks."
      ],
      "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 adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing"
      ],
      "storage_and_handling": [
        "Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, D&C yellow no. 10, FD&C green no.3"
      ],
      "spl_unclassified_section": [
        "Disclaimer *This product is not manufatured or distriubted by Kenvue, Inc., distributor of FreshBurst ® Listerine Antiseptic Mouthwash."
      ],
      "adverse_reactions": [
        "Adverse Reactions QC 100% SATISFACTION GUARANTEED ® Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel Sealed With Printed Neckband For Your Protection NDC 83324-181-33 QC ® QUALITY CHOICE Compare to FreshBurst ® Listerine ® * Antiseptic Mouth Rinse Antigingivitis/Antilaque Kills Germs That Cause: Bad Breath Plaque Gingivitis Gum Disease Spring Mint ® 1 L (1.05 QT) 33.8 FL OZ image description image description"
      ],
      "set_id": "27ff8499-63e0-49ad-a4dd-dde6da584f93",
      "id": "4bcf3aa4-348a-3dcc-e063-6394a90adcfb",
      "effective_time": "20260227",
      "version": "3",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Antiseptic Mouthrinse"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
        ],
        "manufacturer_name": [
          "Chain Drug Marketing Association"
        ],
        "product_ndc": [
          "83324-181"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "4bcf3aa4-348a-3dcc-e063-6394a90adcfb"
        ],
        "spl_set_id": [
          "27ff8499-63e0-49ad-a4dd-dde6da584f93"
        ],
        "package_ndc": [
          "83324-181-33"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}