{
  "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 AM-PM Twin Pack Sodium Fluoride Therabreath Overnight Chamomile Mint SODIUM FLUORIDE WATER GLYCERIN SODIUM BENZOATE SODIUM HYDROXIDE SODIUM CHLORITE CITRIC ACID MONOHYDRATE SUCRALOSE SODIUM FLUORIDE FLUORIDE ION POLYOXYL 40 HYDROGENATED CASTOR OIL TheraBreath Fresh Breath Oral Rinse Invigorating Icy Mint Not Applicable"
      ],
      "spl_unclassified_section": [
        "Drug Facts Overnight Oral Rinse"
      ],
      "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": [
        "Warning Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get 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 help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults 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 30 minutes after rinsing"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, PEG-40 hyrogenated castor oil, citric acid, menthol, sodium benzoate, sodium bicarbonate, sodium chlorite, sodium hydroxide, sucralose, flavor"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel TheraBreath AM + PM TWIN PACK AM POWERED BY OXYGEN TM INVIGORATING ICY MINT PM ANTICAVITY FLUORIDE RINSE CHAMOMILE MINT Helps prvent cavities and rebuild enamel Add TheraBreath to your swishy time routine both day + night! Fights bad breath for 12 hours 72030753 TB AM-PM Combo Carton"
      ],
      "set_id": "4618e390-9039-a1d0-e063-6294a90ab294",
      "id": "4618e390-903a-a1d0-e063-6294a90ab294",
      "effective_time": "20251216",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "TheraBreath AM-PM Twin Pack"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-268"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "4618e390-903a-a1d0-e063-6294a90ab294"
        ],
        "spl_set_id": [
          "4618e390-9039-a1d0-e063-6294a90ab294"
        ],
        "package_ndc": [
          "10237-268-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0697029200254"
        ]
      }
    }
  ]
}