{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "CVS Restore and Defend Sensitive Whitening Stannous fluoride GLYCERIN HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM TRIPOLYPHOSPHATE ANHYDROUS CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM STANNOUS FLUORIDE FLUORIDE ION WATER SACCHARIN SODIUM TITANIUM DIOXIDE SODIUM LAURYL SULFATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 ©2019 CVS/pharmacy CVS.com 1-800-SHOP CVS"
      ],
      "active_ingredient": [
        "Active ingredient Stannous fluoride 0.454% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity / Antihypersensitivity"
      ],
      "indications_and_usage": [
        "Uses aids in the prevention of dental cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact"
      ],
      "warnings": [
        "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 indicate a serious 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."
      ],
      "when_using": [
        "When using this product, if irritation occurs discontinue use."
      ],
      "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 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 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 physican. Make sure to brush all sensitive areas of the teeth. Do not swallow Children under 12 years of age: consult a dentist or doctor"
      ],
      "storage_and_handling": [
        "Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed your dentist. This product is specifically formulated to help prevent staining store below 30°C (86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin"
      ],
      "package_label_principal_display_panel": [
        "CVS Health™ RESTORE & DEFEND SENSITIVE ANTICAVITY TOOTHPASTE WITH FLUORIDE For sensitive teeth & cavity protection Whitening Fresh Mint NET WT 3.4 OZ (96.4 g) CVS_Sensitive_RestoreDefend_Ctn_F8015274"
      ],
      "set_id": "81b72da2-7f41-74ca-e053-2a91aa0a9646",
      "id": "47e5f657-c061-b740-e063-6394a90a114e",
      "effective_time": "20260108",
      "version": "7",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "CVS Restore and Defend Sensitive Whitening"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy"
        ],
        "product_ndc": [
          "69842-218"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "47e5f657-c061-b740-e063-6394a90a114e"
        ],
        "spl_set_id": [
          "81b72da2-7f41-74ca-e053-2a91aa0a9646"
        ],
        "package_ndc": [
          "69842-218-19"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}