{
  "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": [
        "Opalescence Whitening Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION GLYCERIN SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 XANTHAN GUM SODIUM LAURYL SULFATE WATER SORBITOL SODIUM BENZOATE XYLITOL SILICON DIOXIDE METHYL SALICYLATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured by: Ultradent Products, Inc., South Jordan, UT 84095, USA"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium Fluoride 0.25% w/w"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of dental decay."
      ],
      "warnings": [
        "Warnings 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 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 supervision. Children under 2 years of age: Consult a dentist or doctor."
      ],
      "storage_and_handling": [
        "Other Information Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)"
      ],
      "questions": [
        "Questions or comments Call toll-free 1.800.552.5512"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 100 ml Tube Box Opalescence™ whitening toothpaste NET WT. 4.7 oz • 133 g • 100 ml FLUORIDE TOOTHPASTE Original Cool Mint Principal Display Panel - 100 ml Tube Box"
      ],
      "set_id": "d07f842e-b6f1-4ae1-b576-f542ecd02dd4",
      "id": "5b14d90f-23ec-372b-e063-6294a90a2066",
      "effective_time": "20260909",
      "version": "10",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Opalescence Whitening"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Ultradent Products, Inc"
        ],
        "product_ndc": [
          "51206-302"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1044547"
        ],
        "spl_id": [
          "5b14d90f-23ec-372b-e063-6294a90a2066"
        ],
        "spl_set_id": [
          "d07f842e-b6f1-4ae1-b576-f542ecd02dd4"
        ],
        "package_ndc": [
          "51206-302-07",
          "51206-302-10",
          "51206-302-06",
          "51206-302-08",
          "51206-302-09",
          "51206-302-11"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}