{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "HEB Extra Whitening Fluoride WATER SACCHARIN SODIUM SODIUM TRIPOLYPHOSPHATE POLYETHYLENE GLYCOL 400 SORBITOL TITANIUM DIOXIDE SODIUM HYDROXIDE GLYCERIN XANTHAN GUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION mint"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "MADE WITH PRIDE AND CARE FOR H-E-B® SAN ANTONIO, TX 78204 MADE IN USA"
      ],
      "active_ingredient": [
        "Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Antihypersensitivity Anticavity"
      ],
      "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": [
        "Warnings If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and ask a dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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 worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist."
      ],
      "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. Minimize swallowing. Spit out after brushing. Children under 12 years of age: C onsult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin"
      ],
      "storage_and_handling": [
        "Store in a cool dry place. Keep tube capped when not in use."
      ],
      "questions": [
        "Questions or Comments? CALL 1-877-777-2748"
      ],
      "package_label_principal_display_panel": [
        "HEB_SENSITIVE_WHITENING_CARTON_2821169R3"
      ],
      "set_id": "b76c3591-6383-4661-b3db-7a56b11202f7",
      "id": "47e54604-814a-fc9e-e063-6394a90a95f3",
      "effective_time": "20260108",
      "version": "15",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "HEB Extra Whitening"
        ],
        "generic_name": [
          "FLUORIDE"
        ],
        "manufacturer_name": [
          "HEB"
        ],
        "product_ndc": [
          "37808-961"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "47e54604-814a-fc9e-e063-6394a90a95f3"
        ],
        "spl_set_id": [
          "b76c3591-6383-4661-b3db-7a56b11202f7"
        ],
        "package_ndc": [
          "37808-961-12",
          "37808-961-19"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041220819553"
        ],
        "unii": [
          "8ZYQ1474W7",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}