{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "DawnMist Toothpaste SORBITOL WATER SODIUM FLUORIDE FLUORIDE ION SACCHARIN SODIUM CALCIUM CARBONATE SODIUM BENZOATE SODIUM LAURYL SULFATE GUARAPROLOSE (1300 MPA.S AT 1%) SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM"
      ],
      "spl_unclassified_section": [
        "DawnMist Fluoride Toothpaste"
      ],
      "active_ingredient": [
        "Sodium Fluoride 0.22%"
      ],
      "purpose": [
        "Anticavity"
      ],
      "indications_and_usage": [
        "Aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 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 doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist."
      ],
      "inactive_ingredient": [
        "Calcium Carbonate, Carboxymethylcellulose Sodium, Flavor, Guaraprolose, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Water"
      ],
      "package_label_principal_display_panel": [
        "DawnMist Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2005-0 Dukal 0.6oz (17g) RTP06",
        "DawnMist Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2005-1 Dukal 0.85oz (24g) RTP085",
        "DawnMist Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2005-2 Dukal 1.5oz (43g) RTP15",
        "DawnMist Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2005-3 Dukal 2.75oz (78g) RTP27",
        "DawnMist Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2005-4 Dukal 4.75oz (134g) RTP47B",
        "DawnMist Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2005-5 Dukal 6.4oz (181g) RTP64"
      ],
      "set_id": "147f7738-5080-9907-e063-6294a90a6170",
      "id": "2d8d37f1-43ea-5d8b-e063-6394a90a8e1c",
      "effective_time": "20250207",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "DawnMist"
        ],
        "generic_name": [
          "TOOTHPASTE"
        ],
        "manufacturer_name": [
          "Dukal LLC"
        ],
        "product_ndc": [
          "65517-2005"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "245598"
        ],
        "spl_id": [
          "2d8d37f1-43ea-5d8b-e063-6394a90a8e1c"
        ],
        "spl_set_id": [
          "147f7738-5080-9907-e063-6294a90a6170"
        ],
        "package_ndc": [
          "65517-2005-0",
          "65517-2005-1",
          "65517-2005-2",
          "65517-2005-3",
          "65517-2005-4",
          "65517-2005-5"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}