{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Dentisse Sodium Fluoride KAOLIN BENTONITE SODIUM LAURYL SULFATE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM SODIUM PHOSPHATE, DIBASIC XYLITOL SUCRALOSE MENTHOL SODIUM CITRATE"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.243%"
      ],
      "purpose": [
        "Purpose Anticavity Toothpaste"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of dental cavities."
      ],
      "keep_out_of_reach_of_children": [
        "Warnings Keep out of 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 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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supevision. Children under 2 years of age, constult a dentist or a doctor."
      ],
      "warnings": [
        "Other information For your protection, this tube has a foil seal under the cap."
      ],
      "inactive_ingredient": [
        "Inactive ingredients refined kaolin clay, purified water, sorbitol, vegetable glycerin, sodium laurly sulfate, cellulose gum, natural mint flavors, xylitol, bentonite clay, sodium citrate, sodium phosphate, sucralose"
      ],
      "questions": [
        "Questions or comments? Manufactured for Dentisse, Inc. 1-260-444-3046 Fort Wayne, IN 46825 www.dentisse.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel DENTISSE ® Anticavity Fluoride Toothpaste Natural Clay Based Whitening Radiant Mint Net Wt. 3.2 oz. (91 g) Detisse_tube3.2_image.jpg"
      ],
      "set_id": "326b290a-9bd2-468e-e054-00144ff8d46c",
      "id": "42c83cbe-24d7-6ccb-e063-6294a90ab55b",
      "effective_time": "20251104",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Dentisse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Dentisse, Inc."
        ],
        "product_ndc": [
          "70683-0703"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL",
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "42c83cbe-24d7-6ccb-e063-6294a90ab55b"
        ],
        "spl_set_id": [
          "326b290a-9bd2-468e-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "70683-0703-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}