{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Freshen Up SODIUM FLUORIDE, POTASSIUM NITRATE POTASSIUM NITRATE NITRATE ION BENZYL ALCOHOL SODIUM LAURYL SULFATE SODIUM SACCHARIN SORBITOL WATER HYDRATED SILICA PEG-32 CELLULOSE GUM TETRASODIUM PYROPHOSPHATE SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS XYLITOL SODIUM FLUORIDE FLUORIDE ION TITANIUM DIOXIDE SODIUM BENZOATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: MKJ Brands"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion) Potassium Nitrate 5%"
      ],
      "purpose": [
        "Purpose Anticavity Antihypersensitivity"
      ],
      "indications_and_usage": [
        "Use builds increasing protection against painful sensitivity of teeth to cold, heat, acids, sweets or contact aids in prevention of dental cavities"
      ],
      "warnings": [
        "Warnings Stop use and ask a dentist if the problem persists or worsens, snesitive teeth may indicate a serious problem that may need prompt care by dentist. Pain senstivity still persists after 4 weeks of use 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 adults and children 12 years of age and older apply atleast a 1-inch strip of paste onto a soft bristle toothrush. bursh atleast for 2 minutes preferably after each meal or at least twice a day, or as directed by a dentist or physician. Make sure to brush all sensitve areas of the teeth. minimizi swallowing. Spit out after brushing children under 12 years and under ask a dentist or physician"
      ],
      "dosage_and_administration_table": [
        "<table width=\"70%\" styleCode=\"Noautorules\"><colgroup><col align=\"left\" valign=\"top\" width=\"35%\"/><col align=\"left\" valign=\"top\" width=\"65%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 12 years of age and older</td><td>apply atleast a 1-inch strip of paste onto a soft bristle toothrush. bursh atleast for 2 minutes preferably after each meal or at least twice a day, or as directed by a dentist or physician. Make sure to brush all sensitve areas of the teeth. minimizi swallowing. Spit out after brushing</td></tr><tr><td styleCode=\"Rrule\">children under 12 years and under</td><td>ask a dentist or physician</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, cellulose gum, xlitol, sodium saccharin,titanium dioxide, benzyl alcohol,Tri sodium phosphate, sodium benzoate"
      ],
      "questions": [
        "Questions? 1-888-880-1504"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL fuw"
      ],
      "set_id": "2ee626d1-6150-87db-e063-6294a90a64d8",
      "id": "3763947b-98bb-c1f3-e063-6394a90a89ab",
      "effective_time": "20250612",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Freshen Up"
        ],
        "generic_name": [
          "SODIUM FLUORIDE, POTASSIUM NITRATE"
        ],
        "manufacturer_name": [
          "MKJ BRANDS LLC"
        ],
        "product_ndc": [
          "77782-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "3763947b-98bb-c1f3-e063-6394a90a89ab"
        ],
        "spl_set_id": [
          "2ee626d1-6150-87db-e063-6294a90a64d8"
        ],
        "package_ndc": [
          "77782-002-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0855424008336"
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}