{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Sensodyne Extra Whitening Cool Mint potassium nitrate and sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM TRIPOLYPHOSPHATE ANHYDROUS POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE TITANIUM DIOXIDE XANTHAN GUM SODIUM HYDROXIDE SACCHARIN SODIUM POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Cool"
      ],
      "active_ingredient": [
        "Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purposes Antihypersensitivity Anticavity"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. 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."
      ],
      "stop_use": [
        "Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use."
      ],
      "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 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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "Other information do not store above 25°C (77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin"
      ],
      "questions": [
        "Questions or comments? 1-866-844-2797 Additional information ALWAYS FOLLOW THE LABEL What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing. Exposed Dentin 24/7 Sensitivity Protection* + Strong & Healthy Teeth Use Sensodyne Extra Whitening Cool Mint twice dally: • Long lasting sensitivity protection* everyday • Contains fluoride to protect against cavities Trademarks are owned by or licensed to the GSK group of companies. ©2022 GSK group of companies or its licensor. Distributed by: GSK Consumer Healthcare Warren, NJ 07059"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel SENSODYNE #1 DENTIST RECOMMENDED BRAND TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 Sensitivity Protection* + Strong & Healthy Teeth Extra Whitening Cool Mint NET WT 4.0 OZ (113 g) 62000000079742 Front Carton Sensodyne Extra Whitening Cool Mint 4.0 OZ(113 g)"
      ],
      "set_id": "c977f2c4-e0f3-44d2-aa7a-845f0583af3e",
      "id": "12d8be79-e302-098d-e063-6394a90aa50d",
      "effective_time": "20240304",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Sensodyne Extra Whitening Cool Mint"
        ],
        "generic_name": [
          "POTASSIUM NITRATE AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0643"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "12d8be79-e302-098d-e063-6394a90aa50d"
        ],
        "spl_set_id": [
          "c977f2c4-e0f3-44d2-aa7a-845f0583af3e"
        ],
        "package_ndc": [
          "0135-0643-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}