{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "HEB Sensitive Extra Whitening Twin Sodium Fluoride WATER PEG-8 SODIUM FLUORIDE FLUORIDE ION GLYCERIN HYDRATED SILICA POTASSIUM NITRATE NITRATE ION SODIUM SACCHARIN TITANIUM DIOXIDE SODIUM METHYL COCOYL TAURATE XANTHAN GUM SORBITOL SODIUM HYDROXIDE PENTASODIUM TRIPHOSPHATE COCAMIDOPROPYL BETAINE"
      ],
      "active_ingredient": [
        "Potassium nitrate 5% ...................................................... Anthihypersensitivity Sodium Fluoride 0.24% (0.15% w/v fluoride ion) .............Anticavity"
      ],
      "purpose": [
        "Antihypersensitivity Anticavity"
      ],
      "warnings": [
        "When using this product, if irritation occurs discontinue use. 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": [
        "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 twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor. 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 twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age : Consult a dentist or doctor."
      ],
      "indications_and_usage": [
        "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 twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age : Consult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin"
      ],
      "questions": [
        "Questions or comments? 1-877-777-2743"
      ],
      "package_label_principal_display_panel": [
        "HEB_SENSITIVE_WHITENING_CARTON_2PK_2921097R1"
      ],
      "set_id": "41d5ae3e-51c1-263b-e063-6394a90a3312",
      "id": "45775048-8a86-3867-e063-6294a90a6dd2",
      "effective_time": "20251208",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "HEB Sensitive Extra Whitening Twin"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "HEB"
        ],
        "product_ndc": [
          "37808-237"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE",
          "POTASSIUM NITRATE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "45775048-8a86-3867-e063-6294a90a6dd2"
        ],
        "spl_set_id": [
          "41d5ae3e-51c1-263b-e063-6394a90a3312"
        ],
        "package_ndc": [
          "37808-237-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0197870231709"
        ],
        "unii": [
          "8ZYQ1474W7",
          "RU45X2JN0Z"
        ]
      }
    }
  ]
}