{
  "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": [
        "DeCure Sodium Monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM SILICATE SODIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XANTHAN GUM BENZYL ALCOHOL SACCHARIN SODIUM SODIUM BENZOATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "With Fluoride Anticavity Protection Manufactured For: Scope Medical Devices Pvt. Ltd. 11/10, Mandhour Industrial Area, Ambala -134003, India Factory Neutral Code DNH/COS/DNH/52 Ref # :330139 Made in India Exp. Date & Batch No. on crimp."
      ],
      "active_ingredient": [
        "Active Ingredients: Sodium Monofluorophosphate 0.76%"
      ],
      "purpose": [
        "Purpose Anticavity (Total Fluoride Content - 1000 ppm Approx.)"
      ],
      "indications_and_usage": [
        "Uses: Regular brushing with Fluoride toothpaste helps protect teeth roots against cavities."
      ],
      "warnings": [
        "Warnings: Keep out of reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions: Adults and children 2 years and older. Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician Children under 6 yrs. To minimize swallowing use a pea - sized amount and supervise brushing until good habits are established. Children under 2 yrs. Ask a dentist or physician."
      ],
      "dosage_and_administration_table": [
        "<table width=\"80%\"><tbody><tr><td styleCode=\"Botrule Rrule\"><paragraph>Adults and children </paragraph><paragraph>2 years and older.</paragraph></td><td styleCode=\"Botrule\">Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician</td></tr><tr><td styleCode=\"Botrule Rrule\">Children under 6 yrs.</td><td styleCode=\"Botrule\">To minimize swallowing use a pea - sized amount and supervise brushing until good habits are established.</td></tr><tr><td styleCode=\"Botrule Rrule\">Children under 2 yrs.</td><td styleCode=\"Botrule\">Ask a dentist or physician.</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulphate, Flavor, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate"
      ],
      "package_label_principal_display_panel": [
        "Packaging ScopeMedical-100"
      ],
      "set_id": "590c4827-f036-45bd-af30-0a4853ca3447",
      "id": "cdcda1fe-a465-4aca-baba-c3e2114a9952",
      "effective_time": "20240507",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "DeCure"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Scope medical devices private limited"
        ],
        "product_ndc": [
          "84132-100"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "cdcda1fe-a465-4aca-baba-c3e2114a9952"
        ],
        "spl_set_id": [
          "590c4827-f036-45bd-af30-0a4853ca3447"
        ],
        "package_ndc": [
          "84132-100-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}