{
  "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": [
        "Therabreath Plaque Control CETYLPYRIDINIUM CHLORIDE WATER GLYCERIN POLOXAMER 407 SODIUM BENZOATE SUCRALOSE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Cetylpyridinium Chloride 0.075%"
      ],
      "purpose": [
        "Purpose Antigingivitis/Antiplaque"
      ],
      "indications_and_usage": [
        "Uses helps prevent • gingivitis, an early form of gum disease • bleeding gums helps control plaque that leads to • gingivitis • 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=\"60%\" styleCode=\"Noautorules\"><colgroup><col align=\"left\" valign=\"top\" width=\"35%\"/><col align=\"left\" valign=\"top\" width=\"65%\"/></colgroup><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 water, glycerin, poloxamer 407, flavor, sodium benzoate, sucralose"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label USE BEFORE BRUSHING ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE TheraBreath ™ DENTIST FORMULATED PLAQUE CONTROL PRE-BRUSH ORAL RINSE HELPS FIGHT PLAQUE & GINGIVITIS FOR 12 HOURS* Helps reduce gingivitis, an early form of gum disease ANTI-BACTERIAL RINSE • CLEANS WHOLE MOUTH No Alcohol • No Dyes • Non Burning REFRESHING MINT 16 fl. oz. 473 mL *As part of an oral care routine. TB Plaque Control bottle label 72034417"
      ],
      "set_id": "4987c71b-334d-4b20-bab4-b857e08a7383",
      "id": "45b3634b-1017-96be-e063-6294a90aaa8c",
      "effective_time": "20251211",
      "version": "4",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Therabreath Plaque Control"
        ],
        "generic_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-259"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "spl_id": [
          "45b3634b-1017-96be-e063-6294a90aaa8c"
        ],
        "spl_set_id": [
          "4987c71b-334d-4b20-bab4-b857e08a7383"
        ],
        "package_ndc": [
          "10237-259-16",
          "10237-259-26"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0697029996164"
        ],
        "unii": [
          "D9OM4SK49P"
        ]
      }
    }
  ]
}