{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "CVS Pharmacy Restore and Defend Fluoride SACCHARIN SODIUM GLYCERIN WATER SODIUM TRIPOLYPHOSPHATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE STANNOUS FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Stannous Fluoride (0.454% w/w)"
      ],
      "purpose": [
        "Purpose Anticavity/Antihypersensitivity"
      ],
      "indications_and_usage": [
        "Uses builds increasing protection against painful sensitivity of the teeth aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings Stop use and ask a dentist if the problem persists or worsens​. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist pain / sensitivity still persists after 4 weeks Keep out of reach of children. If more than used for brushing is accidently 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 indicate a serious problem that may need prompt care by a dentist pain / sensitivity still persists after 4 weeks"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for brushing is accidently 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 one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth Do not swallow Children under 12 years of age: consult a dentist or doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor"
      ],
      "package_label_principal_display_panel": [
        "Carton label"
      ],
      "set_id": "99f86135-05b7-42b1-aef5-df4513259b8f",
      "id": "439577bb-c849-eca0-e063-6394a90a9246",
      "effective_time": "20251114",
      "version": "10",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "CVS Pharmacy Restore and Defend"
        ],
        "generic_name": [
          "FLUORIDE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy"
        ],
        "product_ndc": [
          "69842-251"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "439577bb-c849-eca0-e063-6394a90a9246"
        ],
        "spl_set_id": [
          "99f86135-05b7-42b1-aef5-df4513259b8f"
        ],
        "package_ndc": [
          "69842-251-19"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}