{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "TheraBreath Sodium Fluoride Therabreath Anticavity Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN SODIUM BENZOATE SODIUM CHLORITE XYLITOL CITRIC ACID SUCRALOSE SODIUM CITRATE, UNSPECIFIED FORM TheraBreath Whitening Fresh Breath Oral Rinse Dazzling Mint"
      ],
      "spl_unclassified_section": [
        "Drug Facts Anticavity Oral Rinse",
        "TheraBreath Whitening Fresh Breath Oral Rinse Dazzling Mint Directions"
      ],
      "active_ingredient": [
        "Active Ingredient 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 Whitening Oral Rinse Keep out of reach of children under 12 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If spilled on fabrics, wash out immediately. This product was sealed with protective packaging. If seal is broken or missing, do not use. Anticavity Oral Rinse 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": [
        "Anticavity Oral Rinse 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 Rinses are not intended to be used together. Always read and follow the product labels."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, flavor, sodium benzoate, sucralose, xylitol, sodium bicarbonate"
      ],
      "package_label_principal_display_panel": [
        "TheraBreath TM WHITENING + ANTICAVITY VARIETY PACK TheraBreath TM DENTIST FORMULATED WHITENING DAZZLING MINT TM + ANTICAVITY SPARKLE MINT ORAL RINSE VARIETY PACK Helps remove stains and prevent future staining Helps fight cavities for 12 hours* *For cavity protection, use as directed. 2 BOTTLES 16 FL OZ (1 PT) 473 mL EACH; 32 FL OZ (1QT) 946mL TOTAL IMPORTANT: Read directions for proper use. TB Whitening-Anticavity Combo 72036907"
      ],
      "set_id": "53c1086d-264b-9d00-e063-6394a90ad19d",
      "id": "5b11930d-111a-400e-e063-6294a90a9e6b",
      "effective_time": "20260909",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "TheraBreath"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-274"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "spl_id": [
          "5b11930d-111a-400e-e063-6294a90a9e6b"
        ],
        "spl_set_id": [
          "53c1086d-264b-9d00-e063-6394a90ad19d"
        ],
        "package_ndc": [
          "10237-274-01",
          "10237-260-16"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}