{
  "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 Potassium nitrate, Sodium fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION GLYCERIN SORBITOL WATER SUCRALOSE SODIUM SACCHARIN SODIUM BICARBONATE HYDRATED SILICA SODIUM METHYL COCOYL TAURATE POLOXAMER 407 XANTHAN GUM TITANIUM DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Potassium nitrate 5.0% Sodium fluoride 0.24% (0.16% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Potassium nitrate - Tooth desensitizer Sodium fluoride - Anticavity"
      ],
      "indications_and_usage": [
        "Uses • aids in the prevention of dental decay • helps reduce and builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact"
      ],
      "warnings": [
        "Warnings Do not use longer than 4 weeks unless recommended by a dentist or doctor Stop use and ask a dentist or doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use longer than 4 weeks unless recommended by a dentist or doctor"
      ],
      "stop_use": [
        "Stop use and ask a dentist or doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. 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 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, sodium methyl cocoyl taurate, flavor, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide, sucralose"
      ],
      "questions": [
        "Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM"
      ],
      "package_label_principal_display_panel": [
        "TheraBreath TM SENSITIVE DENTIST FORMULATED TOOTHPASTE Anticavity for Senstive Teeth PROVIDES 24/7 SENSITIVITY RELIEF* *with twice daily brushing Neutralizes the source of bad breath t t in laboratory tests Gently whitens GENTLE MINT NET WT. 4.0 oz (113g) TB Sensitive Toothpaste Carton TB Sensitive Toothpaste Tube"
      ],
      "set_id": "4b812a38-f7cb-51c8-e063-6394a90ab82c",
      "id": "59906b37-9bbf-710d-e063-6294a90abee4",
      "effective_time": "20260821",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "TheraBreath"
        ],
        "generic_name": [
          "POTASSIUM NITRATE, SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-273"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "59906b37-9bbf-710d-e063-6294a90abee4"
        ],
        "spl_set_id": [
          "4b812a38-f7cb-51c8-e063-6394a90ab82c"
        ],
        "package_ndc": [
          "10237-273-04",
          "10237-273-24",
          "10237-273-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0697029996249"
        ],
        "unii": [
          "8ZYQ1474W7",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}