{
  "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": [
        "biotene sodium monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL GLYCERIN CALCIUM PYROPHOSPHATE WATER HYDRATED SILICA XYLITOL SILICON DIOXIDE HYDROXYETHYL CELLULOSE, UNSPECIFIED ISOCETETH-20 XANTHAN GUM SODIUM BENZOATE CALCIUM LACTATE ANHYDROUS"
      ],
      "active_ingredient": [
        "Active ingredient Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings When using this product, if irritation occurs discontinue use. Keep out of reach of children under 6 years of age. If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product, if irritation occurs discontinue use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for bushing 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: o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor."
      ],
      "storage_and_handling": [
        "Other information store at or below 25ºC (77ºF)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate."
      ],
      "questions": [
        "Questions or comments? Call toll-free 1-800-922-5856"
      ],
      "spl_unclassified_section": [
        "Additional information This product contains no Sodium Lauryl Sulfate (SLS) Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 @2019 GSK group of companies or its licensor. Questions or Comments? 1-800-922-5856"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 0135-0577-01 biotene ® Fluoride Toothpaste SPECIALLY FORMULATED TO NOT IRRITATE Helps prevent cavities & strengthen teeth Gentle Formula GENTLE MINT NET WT 4.3 OZ (121.9g) 1000114 Front Carton Biotene Gentle Mint Original 4.3 oz (121.9g)"
      ],
      "set_id": "a47a6502-efb2-4072-9562-cbe293531c2b",
      "id": "c26f08a5-fa67-417e-8499-015edb65f7f8",
      "effective_time": "20241104",
      "version": "9",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "biotene"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0577"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "c26f08a5-fa67-417e-8499-015edb65f7f8"
        ],
        "spl_set_id": [
          "a47a6502-efb2-4072-9562-cbe293531c2b"
        ],
        "package_ndc": [
          "0135-0577-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}