{
  "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": [
        "CVS Health Sensitive Enamel Repair Sodium Fluoride HYDRATED SILICA COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION XANTHAN GUM POTASSIUM NITRATE NITRATE ION SODIUM SACCHARIN GLYCERIN WATER PEG-8 SORBITOL"
      ],
      "active_ingredient": [
        "Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities"
      ],
      "warnings": [
        "When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicare a seriuous problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicare a seriuous problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. 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 older : apply at least a 1-inch strip of the product into a soft bristle toothbrush brus teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all snesitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide"
      ],
      "purpose": [
        "Antihypersensitivity Anticavity"
      ],
      "package_label_principal_display_panel": [
        "CVS_EnamelREpair_Intensive_2821093R1"
      ],
      "set_id": "41d547b3-2feb-8e83-e063-6294a90ae3cd",
      "id": "47f95dac-296a-3639-e063-6394a90abc25",
      "effective_time": "20260109",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "CVS Health Sensitive Enamel Repair"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "CVS"
        ],
        "product_ndc": [
          "51316-169"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1086243"
        ],
        "spl_id": [
          "47f95dac-296a-3639-e063-6394a90abc25"
        ],
        "spl_set_id": [
          "41d547b3-2feb-8e83-e063-6294a90ae3cd"
        ],
        "package_ndc": [
          "51316-169-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}