{
  "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": [
        "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"
      ],
      "active_ingredient": [
        "Active ingredient 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 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 and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks 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 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 and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth 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 (59⁰-77⁰F)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel"
      ],
      "adverse_reactions": [
        "ADVERSE REACTION 100% Satisfaction Guaranteed If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied. (888)309-9030 Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc. Distributed by Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072 DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel Since 1903 Rexall™ Amber Antiseptic Mouthwash Antigingivitis/Antiplaque Kills 99.9% of germs commonly associated with gingivitis Fights bad breath Helps reduce plaque ADA Accepted Amrican Dental Association Helps prevent and reduce plaque Helps prevent and reduce gingivitis 1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ image description image description"
      ],
      "set_id": "76554d61-ed96-4631-9140-135f1a2e282b",
      "id": "4c0f7ccc-21fb-c732-e063-6294a90aa9c4",
      "effective_time": "20260302",
      "version": "26",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Mouth Rinse"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
        ],
        "manufacturer_name": [
          "Old East Main Co."
        ],
        "product_ndc": [
          "55910-318"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "4c0f7ccc-21fb-c732-e063-6294a90aa9c4"
        ],
        "spl_set_id": [
          "76554d61-ed96-4631-9140-135f1a2e282b"
        ],
        "package_ndc": [
          "55910-318-12",
          "55910-318-77",
          "55910-318-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}