{
  "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 Overnight Chamomile Mint SODIUM FLUORIDE WATER GLYCERIN SODIUM BENZOATE SODIUM HYDROXIDE SODIUM CHLORITE CITRIC ACID MONOHYDRATE SUCRALOSE POLYOXYL 40 HYDROGENATED CASTOR OIL SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium Fluoride 0.05% (0.02% wh fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away. Do not use with another fluoride rinse on the same day."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use with another fluoride rinse on the same day."
      ],
      "dosage_and_administration": [
        "Directions Adults 18 years of age or older: Use once a day atter brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing."
      ],
      "storage_and_handling": [
        "Other information Do not use if safety seal is broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Flavor, Citric Acid, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Sodium Chlorite, Sodium Hydroxide, Sucralose"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label ANTICAVITY FLUORIDE RINSE STRENGTHENS TEETH TheraBreath ™ DENTIST FORMULATED OVERNIGHT ORAL RINSE FIGHTS BAD BREATH FOR 12 HOURS* HELPS PREVENT CAVITIES & REBUILD ENAMEL No Alcohol • No Dyes Non Burning IMPORTANT: Read directions for proper use. 16 fl. oz. 473 mL CHAMOMILE MINT PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"
      ],
      "set_id": "cc0c533c-145e-4877-b421-1baf3a3a572e",
      "id": "45a8183b-aa06-ed02-e063-6394a90a46f5",
      "effective_time": "20251211",
      "version": "4",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Therabreath Overnight Chamomile Mint"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-262"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "45a8183b-aa06-ed02-e063-6394a90a46f5"
        ],
        "spl_set_id": [
          "cc0c533c-145e-4877-b421-1baf3a3a572e"
        ],
        "package_ndc": [
          "10237-262-16",
          "10237-262-26"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}