{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Opalescence Whitening Sensitivity Relief Potassium Nitrate and Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION SILICON DIOXIDE SUCRALOSE CARBOMER SODIUM LAURYL SULFATE POLOXAMER 407 FD&C YELLOW NO. 5 SORBITOL METHYL SALICYLATE XYLITOL SODIUM BENZOATE SODIUM HYDROXIDE AQUA XANTHAN GUM GLYCERIN FD&C BLUE NO. 1 Cool Mint"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Potassium Nitrate 5% w/w Sodium Fluoride 0.24% w/w"
      ],
      "purpose": [
        "Purpose Antihypersensitivity Anticavity"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of dental cavities Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact"
      ],
      "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 yeasrs 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 Aqua (Water), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate, Sodium Lauryl Sulfate, Carbomer, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum"
      ],
      "questions": [
        "Questions or comments Call toll-free 1.800.552.5512"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - 4.7 oz Tube Carton Opalescence Whitening Toothpaste Sensitivity Relief Cool Mint NET WT. 4.7 oz * 133 g 8 100 ml FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH Opalescence Whitening Toothpaste Sensitivity Relief_4.7 oz Tube Carton"
      ],
      "set_id": "44e94663-895b-67da-e063-6394a90a5fe6",
      "id": "5b14ca86-96a0-7c20-e063-6394a90af5bd",
      "effective_time": "20260909",
      "version": "3",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Opalescence Whitening Sensitivity Relief"
        ],
        "generic_name": [
          "POTASSIUM NITRATE AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Ultradent Products, Inc."
        ],
        "product_ndc": [
          "51206-315"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "5b14ca86-96a0-7c20-e063-6394a90af5bd"
        ],
        "spl_set_id": [
          "44e94663-895b-67da-e063-6394a90a5fe6"
        ],
        "package_ndc": [
          "51206-315-01",
          "51206-315-02",
          "51206-315-03",
          "51206-315-04",
          "51206-315-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}