{
  "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": [
        "Opal by Opalescence Sensitivity Potassium Nitrate and Sodium Fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION SILICON DIOXIDE XYLITOL WATER GLYCERIN SORBITOL POLOXAMER 407 METHYL SALICYLATE SODIUM LAURYL SULFATE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 FD&C YELLOW NO. 5 SODIUM BENZOATE SODIUM HYDROXIDE SUCRALOSE XANTHAN GUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Purpose Potassium Nitrate 5% w/w Antihypersensitivity Sodium Fluoride 0.25% w/w Anticavity"
      ],
      "active_ingredient_table": [
        "<table width=\"55%\"><col width=\"75%\" align=\"left\" valign=\"middle\"/><col width=\"25%\" align=\"right\" valign=\"middle\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active Ingredients</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>Potassium Nitrate 5% w/w</td><td>Antihypersensitivity</td></tr><tr><td>Sodium Fluoride 0.25% w/w</td><td>Anticavity</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active Ingredients Purpose Potassium Nitrate 5% w/w Antihypersensitivity Sodium Fluoride 0.25% w/w Anticavity"
      ],
      "purpose_table": [
        "<table width=\"55%\"><col width=\"75%\" align=\"left\" valign=\"middle\"/><col width=\"25%\" align=\"right\" valign=\"middle\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active Ingredients</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>Potassium Nitrate 5% w/w</td><td>Antihypersensitivity</td></tr><tr><td>Sodium Fluoride 0.25% w/w</td><td>Anticavity</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor. 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 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 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 Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate (flavor), Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum"
      ],
      "questions": [
        "Questions or comments Call toll-free 1.800.496.8330"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton opal™ by Opalescence ® Whitening Toothpaste SENSITIVITY RELIEF COOL MINT FLUORIDE TOOTHPASTE NET WT. 4.7 OZ PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton"
      ],
      "set_id": "5ffc0d14-0290-47bb-90e5-90a25a5acc28",
      "id": "5b14ee76-2fcb-639e-e063-6294a90a9211",
      "effective_time": "20260909",
      "version": "6",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Opal by Opalescence Sensitivity"
        ],
        "generic_name": [
          "POTASSIUM NITRATE AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Ultradent Products, Inc."
        ],
        "product_ndc": [
          "51206-311"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1086243"
        ],
        "spl_id": [
          "5b14ee76-2fcb-639e-e063-6294a90a9211"
        ],
        "spl_set_id": [
          "5ffc0d14-0290-47bb-90e5-90a25a5acc28"
        ],
        "package_ndc": [
          "51206-311-02",
          "51206-311-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}