{
  "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": [
        "Freshen Up SODIUM FLUORIDE HYDROXYPROPYL METHYLCELLULOSE BENZYL ALCOHOL SODIUM LAURYL SULFATE SODIUM BENZOATE SORBITOL WATER HYDRATED SILICA PEG-32 SACCHARIN SODIUM CELLULOSE GUM TETRASODIUM PYROPHOSPHATE COCAMIDOPROPYL BETAINE TETRAPOTASSIUM PYROPHOSPHATE FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION TITANIUM DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: MKJ Brands"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use helps protect against cavities"
      ],
      "warnings": [
        "Warnings 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 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 physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician"
      ],
      "dosage_and_administration_table": [
        "<table width=\"70%\" styleCode=\"Noautorules\"><col width=\"35%\" align=\"left\" valign=\"top\"/><col width=\"65%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">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 physician</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 2 to 6 years</td><td>use only a pea sized amount and supervise child&apos;s brushing and rinsing (to minimize swallowing)</td></tr><tr><td styleCode=\"Rrule\">children under 2 years</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, cocamidopropyl betaine, sodium saccharin,hydroxypropyl methylcellulose, FD&C blue no. 1,titanium dioxide, benzyl alcohol,tetra potassium pyrophosphate"
      ],
      "questions": [
        "Questions? 1-888-880-1504"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 130 g Bottle Label Fu 1411"
      ],
      "set_id": "56acecd2-6966-2ee4-e063-6394a90a356f",
      "id": "56acecd2-6967-2ee4-e063-6394a90a356f",
      "effective_time": "20260715",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Freshen Up"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "DABUR INDIA LIMITED"
        ],
        "product_ndc": [
          "87846-007"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "56acecd2-6967-2ee4-e063-6394a90a356f"
        ],
        "spl_set_id": [
          "56acecd2-6966-2ee4-e063-6394a90a356f"
        ],
        "package_ndc": [
          "87846-007-13",
          "87846-007-14"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0855424008213"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}