{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Therabreath Whitening Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SODIUM BICARBONATE SODIUM TRIPOLYPHOSPHATE SODIUM LAUROYL SARCOSINATE SUCRALOSE TITANIUM DIOXIDE SORBITOL HYDRATED SILICA SODIUM LAURYL SULFATE POLOXAMER 407 GLYCERIN SODIUM SACCHARIN TETRASODIUM PYROPHOSPHATE XANTHAN GUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium fluoride 0.24% (0.17% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental decay"
      ],
      "warnings": [
        "Warning Keep out of reach of children under 6 years of age. If more than used for brushing 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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions • do not swallow • supervise children as necessary until capable of using without supervision adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years of age consult a dentist or doctor"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\" cellpadding=\"2\" width=\"60%\"><tbody><tr><td>adults and children 2 years of age and older</td><td>brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor</td></tr><tr><td>children under 6 years of age</td><td><paragraph>instruct in good brushing and rinsing habits (to minimize swallowing)</paragraph></td></tr><tr><td>children under 2 years of age</td><td>consult a dentist or doctor</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, sodium tripolyphosphate, flavor, sodium lauryI sulfate, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide, sodium saccharin, sucralose"
      ],
      "questions": [
        "Questions or Comments? TheraBreath is manufactured by Church & Dwight Co., Inc. Ewing, NJ 08628 U.S.A. Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM"
      ],
      "package_label_principal_display_panel": [
        "Prinicpal Display Panel LONG LASTING FOR EPIC FRESHNESS TheraBreath ™ WHITENING DENTIST FORMULATED TOOTHPASTE Anticavity SIGNIFICANTLY WHITENS AFTER 1 WEEK* TWIN PACK *with twice daily brushing Neutralizes the source of bad breath t t in laboratory tests Gently whitens Dr. Harold Katz Dazzling Mint 2 TUBES of 4.0 oz (113 g) TOTAL NET WT. 8.0 oz (226 g) TB Whitening Toothpaste 4 oz Twin Carton TB Whitening Toothpaste 4 oz Tube"
      ],
      "set_id": "3ba04b55-38f9-76f3-e063-6394a90a3c03",
      "id": "59903e71-6c38-3ffb-e063-6294a90afad7",
      "effective_time": "20260821",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Therabreath Whitening"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-272"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "59903e71-6c38-3ffb-e063-6294a90afad7"
        ],
        "spl_set_id": [
          "3ba04b55-38f9-76f3-e063-6394a90a3c03"
        ],
        "package_ndc": [
          "10237-272-24",
          "10237-272-04",
          "10237-272-07"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}