{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Therabreath Anticavity SODIUM FLUORIDE WATER GLYCERIN SODIUM BENZOATE SODIUM HYDROXIDE SODIUM CHLORITE XYLITOL CITRIC ACID MONOHYDRATE SUCRALOSE SODIUM CITRATE, UNSPECIFIED FORM SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium Fluoride 0.05% (0.02% w/v 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, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the 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 18 years of age or older: Use once a day after 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, Glycerin, PEG-40 Hydrogenated Castor Oil, Citric Acid, Sodium Hydroxide, Sodium Chlorite, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label USE 1X DAILY ANTICAVITY FLUORIDE RINSE TheraBreath™ DENTIST FORMULATED ANTICAVITY ORAL RINSE HELPS FIGHT CAVITIES FOR 12 HOURS* STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH Helps rebuild weakened tooth enamel and prevent cavities No Alcohol • Powered by Fluoride • Non-Burning Sodium Fluoride 0.05% IMPORTANT: Read directions for proper use. Dr. Harold Katz 16 fl.oz. (1 pt.) 473 mL SPARKLE MINT TB Anticavity Label 72032543"
      ],
      "set_id": "feab3d45-ff95-4b32-8258-7d932a7380c9",
      "id": "53d7150b-d8de-145c-e063-6394a90ac434",
      "effective_time": "20260601",
      "version": "5",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Therabreath Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-260"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "53d7150b-d8de-145c-e063-6394a90ac434"
        ],
        "spl_set_id": [
          "feab3d45-ff95-4b32-8258-7d932a7380c9"
        ],
        "package_ndc": [
          "10237-260-16",
          "10237-260-01",
          "10237-260-03",
          "10237-260-26",
          "10237-260-10",
          "10237-260-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0697029192030"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}