{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "TheraBreath Anticavity Sodium Fluoride WATER GLYCERIN POLYOXYL 40 HYDROGENATED CASTOR OIL CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE SODIUM CHLORITE MENTHOL, UNSPECIFIED FORM LEMON OIL, COLD PRESSED PEPPERMINT OIL SODIUM BENZOATE SUCRALOSE XYLITOL SODIUM BICARBONATE SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "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"
      ],
      "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 - 1 L Bottle Label ANTICAVITY FLUORIDE RINSE USE 2X DAILY TheraBreath ™ DENTIST FORMULATED ANTICAVITY ORAL RINSE HELPS FIGHT CAVITIES FOR 24 HOURS* STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH Helps rebuild weakened tooth enamel and prevent tooth decay No Alcohol • With Fluoride • Non-Burning Sodium Fluoride 0.02% IMPORTANT: Read directions for proper use. 33.8 FL OZ (1.05 QT) 1 L SPARKLE MINT PRINCIPAL DISPLAY PANEL - 1 L Bottle Label"
      ],
      "set_id": "3c5d58f1-ea8c-4708-bbc6-21e1cd1446da",
      "id": "3e626c65-3a8b-ec3c-e063-6394a90ad8f4",
      "effective_time": "20250919",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "TheraBreath Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-265"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "3e626c65-3a8b-ec3c-e063-6394a90ad8f4"
        ],
        "spl_set_id": [
          "3c5d58f1-ea8c-4708-bbc6-21e1cd1446da"
        ],
        "package_ndc": [
          "10237-265-01",
          "10237-265-21"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}