{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "TheraBreath Cetylpyridinium chloride Therabreath Deep Clean Fresh Mint CETYLPYRIDINIUM CHLORIDE WATER GLYCERIN CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM SUCRALOSE POLOXAMER 407 TheraBreath Healthy Gums CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM GLYCERIN POLOXAMER 407 SUCRALOSE WATER"
      ],
      "spl_unclassified_section": [
        "TheraBreath Healthy Gums + Deep Clean Variety Pack",
        "Drug Facts TheraBreath Healthy Gums Oral Rinse",
        "Drug Facts TheraBreath Deep Clean Oral Rinse"
      ],
      "active_ingredient": [
        "Active ingredient Cetylpyridinium chloride 0.05%",
        "Active Ingredient Cetylpyridinium chloride 0.1%"
      ],
      "purpose": [
        "Purpose Antigingivitis/Antiplaque",
        "Purpose Antigingivitis/Antiplaque"
      ],
      "indications_and_usage": [
        "Uses helps prevent • gingivitis, an early form of gum disease • bleeding gums helps control plaque that leads to • gingivitus • bleeding gums",
        "Uses helps prevent • gingivitis, an early form of gum disease • bleeding gums helps control plaque that leads to • gingivitus • 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.",
        "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 reachof 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."
      ],
      "ask_doctor": [
        "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.",
        "Keep out of reachof 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 rinse. children 6 years to under 12 years supervise use children under 6 years do not use",
        "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 border=\"1\" width=\"65%\"><tbody><tr><td>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 rinse.</td></tr><tr><td>children 6 years to under 12 years</td><td>supervise use</td></tr><tr><td>children under 6 years</td><td>do not use</td></tr></tbody></table>",
        "<table border=\"1\" width=\"65%\"><tbody><tr><td>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><td>children 6 years to under 12 years</td><td>supervise use</td></tr><tr><td>children under 6 years</td><td>do not use</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information this rinse is not intended to replace brushing or flossing do not use both oral rinses together.",
        "Other information this rinse is not intended to replace brushing or flossing do not use both oral rinses together."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, poloxamer 407, flavor, sucralose",
        "Inactive ingredients water, glycerin, poloxamer 407, flavor, sucralose"
      ],
      "questions": [
        "Church & Dwight Co., Inc. PHONE: 1-800-973-7374 WEB: THERABREATH.COM",
        "Church & Dwight Co., Inc. PHONE: 1-800-973-7374 WEB: THERABREATH.COM"
      ],
      "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."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel TheraBreath TM HEALTHY GUMS + DEEP CLEAN ANTIGINGIVITIS/ANTIPLAQUE VARIETY PACK Add TheraBreath to your swishy time routine for healthy gums or a deep clean Helps fight gingivitis for 12 hours Kills 99.9% of germs that cause bad breath, plaque & gingivitis* *in laboratory tests TheraBreath HEALTHY GUMS CLEAN MINT TheraBreath DEEP CLEAN FRESH MINT 2 BOTTLES 16 FL OZ (1 PT) 473 mL each; 32 FL OZ (1 qt) 946 mL TOTAL TB Healthy Gums - Deep Clean 16 oz Variety Pack Carton"
      ],
      "set_id": "4b803b5f-0d8c-a3e0-e063-6294a90a2ecf",
      "id": "4b803b5f-0d8d-a3e0-e063-6294a90a2ecf",
      "effective_time": "20260101",
      "version": "1",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "TheraBreath"
        ],
        "generic_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-269"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "1251772"
        ],
        "spl_id": [
          "4b803b5f-0d8d-a3e0-e063-6294a90a2ecf"
        ],
        "spl_set_id": [
          "4b803b5f-0d8c-a3e0-e063-6294a90a2ecf"
        ],
        "package_ndc": [
          "10237-269-01",
          "10237-261-16",
          "10237-258-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0697029996324"
        ]
      }
    }
  ]
}