{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 37
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Made by Dentists Sensitive and Whitening Fresh Mint POTASSIUM NITRATE, SODIUM FLUORIDE WATER SORBITOL HYDRATED SILICA XYLITOL COCAMIDOPROPYL BETAINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM TRIPOLYPHOSPHATE ANHYDROUS TITANIUM DIOXIDE SACCHARIN SODIUM POTASSIUM SORBATE HYDROGEN PEROXIDE SODIUM BICARBONATE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient: Potassium Nitrate 5.0% Sodium Fluoride 0.24% (0.15% w/v fluoride ion) Purpose Antisensitivity Anticavity"
      ],
      "purpose": [
        "Purpose Antisensitivity Anticavity"
      ],
      "indications_and_usage": [
        "Use: Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact."
      ],
      "warnings": [
        "Warnings: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentlly 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 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Water (Aqua), Sorbitol, Hydrated Silica, Xylitol, Flavor, Cocamidopropyl Betaine, Cellulose Gum, Pentasodium Triphosphate, Titanium Dioxide, Sodium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate"
      ],
      "questions": [
        "Questions or comments? + 1 (646) 980-6461"
      ],
      "package_label_principal_display_panel": [
        "Label Label tube label"
      ],
      "set_id": "0d379c26-69ff-4666-9ad5-7618f0bd139f",
      "id": "125c746e-12f0-07cf-e063-6294a90ac1ca",
      "effective_time": "20240227",
      "version": "1",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Made by Dentists Sensitive and Whitening Fresh Mint"
        ],
        "generic_name": [
          "POTASSIUM NITRATE, SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "MADE BY DENTISTS INC"
        ],
        "product_ndc": [
          "75065-029"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "125c746e-12f0-07cf-e063-6294a90ac1ca"
        ],
        "spl_set_id": [
          "0d379c26-69ff-4666-9ad5-7618f0bd139f"
        ],
        "package_ndc": [
          "75065-029-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850031970724"
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}