{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Therabreath Deep Clean Fresh Mint CETYLPYRIDINIUM CHLORIDE WATER GLYCERIN POLOXAMER 407 SUCRALOSE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Cetylpyridinium Chloride 0.1%"
      ],
      "purpose": [
        "Purpose Antigingivitis/Antiplaque"
      ],
      "indications_and_usage": [
        "Uses Helps prevent gingivitis, an early form of gum disease and bleeding gums Helps control plaque that leads to gingivitis and bleeding gums"
      ],
      "warnings": [
        "Warnings 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 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 right away."
      ],
      "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 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 right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and Children 12 years and older Vigorously swish 20 milliliters (4 teaspoonfuls) 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 Supervise use. Children under 6 years Do not use."
      ],
      "dosage_and_administration_table": [
        "<table width=\"50%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Adults and Children 12 years and older</td><td>Vigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Children 6 years to under 12 years</td><td>Supervise use.</td></tr><tr><td styleCode=\"Rrule\">Children under 6 years</td><td>Do not use.</td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information This rinse is not intended to replace brushing or flossing."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Flavor, Glycerin, Poloxamer 407, Sucralose, Water"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label ALCOHOL FREE ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE TheraBreath ™ DENTIST FORMULATED DEEP CLEAN ORAL RINSE KILLS 99.9% OF GERMS THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS* ANTISEPTIC No Alcohol • No Dyes • Non Burning FRESH MINT 16 fl.oz. 473 mL PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"
      ],
      "set_id": "19bb1bc2-f4e3-4faa-82a5-656fec4397dd",
      "id": "453a6780-e9fb-e694-e063-6294a90a2122",
      "effective_time": "20251205",
      "version": "3",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Therabreath Deep Clean Fresh Mint"
        ],
        "generic_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-261"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "rxcui": [
          "1251772"
        ],
        "spl_id": [
          "453a6780-e9fb-e694-e063-6294a90a2122"
        ],
        "spl_set_id": [
          "19bb1bc2-f4e3-4faa-82a5-656fec4397dd"
        ],
        "package_ndc": [
          "10237-261-16",
          "10237-261-03",
          "10237-261-01",
          "10237-261-26"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "D9OM4SK49P"
        ]
      }
    }
  ]
}