{
  "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": [
        "Gum and Enamel Repair Stannous fluoride WATER HYDRATED SILICA SORBITOL SODIUM LAURYL SULFATE XANTHAN GUM ZINC CITRATE STANNOUS FLUORIDE FLUORIDE ION SACCHARIN SODIUM SACCHARIN SUCRALOSE SODIUM HYDROXIDE CARRAGEENAN TITANIUM DIOXIDE"
      ],
      "active_ingredient": [
        "Stannous fluoride 0.454% (0.14% w/v fluoride ion)"
      ],
      "purpose": [
        "Anticavity/antigingivitis"
      ],
      "indications_and_usage": [
        "aids in the prevention of cavities * helps prevent gingivitis * helps interferre with the harmful effects of plaque associated with gingivisits * helps control plaque bacteria that contribute to the development of gingivitis"
      ],
      "warnings": [
        "Keep out of reach of children under 12 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 12 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": [
        "adults and children 12 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 physician * do not swallow * children under 12 years of age: ask a dentist"
      ],
      "other_safety_information": [
        "products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing my prevent these stains which are not harmful or permanent and may be removed by your dentist * this product is specifically formulated to help prevent staining * see your dentist regularly"
      ],
      "inactive_ingredient": [
        "water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide"
      ],
      "package_label_principal_display_panel": [
        "Carton R1"
      ],
      "set_id": "ccad05d4-7f05-bebd-e053-2a95a90aa52c",
      "id": "47e6024c-0154-bf83-e063-6294a90a94cf",
      "effective_time": "20260108",
      "version": "5",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Gum and Enamel Repair"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "CVS"
        ],
        "product_ndc": [
          "69842-645"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "47e6024c-0154-bf83-e063-6294a90a94cf"
        ],
        "spl_set_id": [
          "ccad05d4-7f05-bebd-e053-2a95a90aa52c"
        ],
        "package_ndc": [
          "69842-645-59"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}