{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol WATER ALCOHOL BENZOIC ACID POLOXAMER 407 SODIUM BENZOATE CARAMEL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL"
      ],
      "spl_unclassified_section": [
        "Tamper Evident Statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION",
        "Disclaimer *This product is not manufactered or distributed by Kenvue, Inc., distributor of Listerine Original Antiseptic Mouthwash.",
        "Claims ADA Accepted American Dental Association Helps prevent and reduce plaque Helps prevent and reduce gingivitis"
      ],
      "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 (59° - 77°F)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel"
      ],
      "questions": [
        "Questions or comments? Call 1-888-593-0593"
      ],
      "adverse_reactions": [
        "Adverse reactions MADE WITH PRIDE AND CARE FOR H-E-B ® SAN ANTONIO, TX 78204 100% GUARANTEE promise If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it. DSP-TN-21091 DSP-MO-20087 PLASTIC BOTTLE Widely Recyclable Discard Seal, Empty & Replace Cap US ONLY how2recycle.info"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel Compare to Listerine ® Original Antiseptic Mouthwash* H-E-B ® Original ANTISEPTIC ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH Helps Fight Bad-Beath Germs, Plaque & Gingivitis ADA Accepted American Dental Association ® 33.8 FL OZ (1.05 QT) 1 L image description image description"
      ],
      "set_id": "8ba4382d-1a88-4a8d-9d40-c0f38cfd01a5",
      "id": "4a9014de-51a1-319c-e063-6394a90a4632",
      "effective_time": "20260211",
      "version": "16",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Antiseptic Mouth Rinse"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
        ],
        "manufacturer_name": [
          "H E B"
        ],
        "product_ndc": [
          "37808-318"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "4a9014de-51a1-319c-e063-6394a90a4632"
        ],
        "spl_set_id": [
          "8ba4382d-1a88-4a8d-9d40-c0f38cfd01a5"
        ],
        "package_ndc": [
          "37808-318-86",
          "37808-318-77",
          "37808-318-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}