{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE potassium nitrate and sodium fluoride SORBITOL WATER SILICON DIOXIDE SODIUM LAURYL SULFATE XANTHAN GUM SACCHARIN SODIUM SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED TITANIUM DIOXIDE FD&C BLUE NO. 1 D&C YELLOW NO. 10 POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active Ingredients Potassium Nitrate 5% Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Antihypersensitivity Anticavity"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact. aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warning"
      ],
      "when_using": [
        "When using this product if pain\\ sensitivity still persists after 4 weeks of use, please visit your dentist."
      ],
      "stop_use": [
        "Stop and ask a dentist if the problem persists or worsens. Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years of age and older apply at least a 1-inch strip of product onto soft bristle toothbrush brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor."
      ],
      "spl_unclassified_section": [
        "Other information store in a cool, dry place."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE label"
      ],
      "set_id": "fcf59439-7e06-4129-a89f-cdeecdf8d488",
      "id": "1199f2f8-98e4-4b76-9be9-3b921495a3c3",
      "effective_time": "20231117",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE"
        ],
        "generic_name": [
          "POTASSIUM NITRATE AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Universal Distribution Center LLC"
        ],
        "product_ndc": [
          "52000-109"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1038841"
        ],
        "spl_id": [
          "1199f2f8-98e4-4b76-9be9-3b921495a3c3"
        ],
        "spl_set_id": [
          "fcf59439-7e06-4129-a89f-cdeecdf8d488"
        ],
        "package_ndc": [
          "52000-109-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}