{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Freshen Up SODIUM FLUORIDE, POTASSIUM NITRATE BENZYL ALCOHOL SODIUM LAURYL SULFATE SODIUM SACCHARIN SORBITOL WATER HYDRATED SILICA PEG-400 XANTHAN GUM TETRASODIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM SILICATE TITANIUM DIOXIDE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CI 42090"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: MKJ Brands"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Monofluorophosphate (0.76%)........Anticavity Total Fluoride content- 1000 ppm appx."
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use helps protect against 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 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by physician or dentist children 2 to 6 years use only a pea siz 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\"><colgroup><col align=\"left\" valign=\"top\" width=\"35%\"/><col align=\"left\" valign=\"top\" width=\"65%\"/></colgroup><tbody><tr><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 physician or dentist</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 2 to 6 years</td><td>use only a pea siz 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 calcium carbonate, water, sorbitol, silica, SLS, flavor, sodium silicate, tetrasodium pyrophosphate, xanthum gum, sodium carboxymethylcellulose, benzyl alcohol, sodium benzoate, sodium bicarbonate, sodium saccharin, titanium dioxide, peg-400, blue 1"
      ],
      "questions": [
        "Questions? 1-888-880-1504"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL col (1)"
      ],
      "set_id": "476f453b-9215-0a11-e063-6294a90a5cd4",
      "id": "56964f07-211c-29b1-e063-6394a90a214f",
      "effective_time": "20260714",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Freshen Up"
        ],
        "generic_name": [
          "SODIUM FLUORIDE, POTASSIUM NITRATE"
        ],
        "manufacturer_name": [
          "MKJ BRANDS LLC"
        ],
        "product_ndc": [
          "77782-005"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "56964f07-211c-29b1-e063-6394a90a214f"
        ],
        "spl_set_id": [
          "476f453b-9215-0a11-e063-6294a90a5cd4"
        ],
        "package_ndc": [
          "77782-005-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}