{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "TheraBreath Complete Oral Rinse Anticavity Oral Rinse SUCRALOSE PEG-40 HYDROGENATED CASTOR OIL SODIUM BICARBONATE CITRIC ACID SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION GLYCERIN WATER SODIUM CHLORITE SODIUM BENZOATE"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Sodium fluoride 0.02% (0.01% w/v fluoride ion)"
      ],
      "purpose": [
        "PURPOSE Anticavity"
      ],
      "indications_and_usage": [
        "USE aids in the prevention of dental cavities"
      ],
      "warnings": [
        "WARNING Keep out of 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 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 18 years of age and older: • use twice 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"
      ],
      "other_safety_information": [
        "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, flavor, sodium benzoate, sucralose, sodium bicarbonate"
      ],
      "package_label_principal_display_panel": [
        "NO ALCOHOL, NON BURNING ANTICAVITY FLUORIDE RINSE THERABREATH TM DENTIST FORMULATED COMPLETE ORAL RINSE 6 BENEFITS IN 1 Fights Cavities • Freshens Breath Kills Bad Breath Bacteria • Cleans Whole Mouth Strengthens Teeth • Helps Rebuild Enamel Dr. Harold Katz REVITALIZING MINT IMPORTANT: Read directions for proper use. 16 fl. oz. (1 pt.) 473 mL TB Complete"
      ],
      "set_id": "27c33ae1-52c7-baad-e063-6394a90a0611",
      "id": "4b7fc579-156a-6f86-e063-6394a90ab66a",
      "effective_time": "20260223",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "TheraBreath Complete Oral Rinse"
        ],
        "generic_name": [
          "ANTICAVITY ORAL RINSE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-267"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "4b7fc579-156a-6f86-e063-6394a90ab66a"
        ],
        "spl_set_id": [
          "27c33ae1-52c7-baad-e063-6394a90a0611"
        ],
        "package_ndc": [
          "10237-267-16",
          "10237-267-26"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}