{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "H E B Restore and Defend Fluoride SORBITOL GLYCERIN SACCHARIN SODIUM WATER TITANIUM DIOXIDE SODIUM TRIPOLYPHOSPHATE ANHYDROUS CARBOXYMETHYLCELLULOSE SODIUM COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE HYDRATED SILICA STANNOUS FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "MADE WITH PRIDE AND CARE FOR H-E-B® SAN ANTONIO, TX 78204"
      ],
      "active_ingredient": [
        "Active ingredients 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 directed 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 glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin"
      ],
      "questions": [
        "Questions or Comments? CALL 1-877-777-2743"
      ],
      "other_safety_information": [
        "Other information products containng stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may 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."
      ],
      "package_label_principal_display_panel": [
        "HEB_RESTORE_DEFEND_CTN_2821230R3"
      ],
      "set_id": "56080493-9ab8-4b4f-be5f-7df22dee133f",
      "id": "47e52621-fd2a-850a-e063-6294a90affff",
      "effective_time": "20260108",
      "version": "15",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "H E B Restore and Defend"
        ],
        "generic_name": [
          "FLUORIDE"
        ],
        "manufacturer_name": [
          "HEB"
        ],
        "product_ndc": [
          "37808-230"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "47e52621-fd2a-850a-e063-6294a90affff"
        ],
        "spl_set_id": [
          "56080493-9ab8-4b4f-be5f-7df22dee133f"
        ],
        "package_ndc": [
          "37808-230-09",
          "37808-230-92"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041220996506"
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}