{
  "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": [
        "AQUAFRESH SENSITIVE MAXIMUM STRENGTH potassium nitrate and sodium fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM LAURYL SULFATE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE MENTHOL, UNSPECIFIED FORM D&C RED NO. 30 FD&C BLUE NO. 1 smooth mint"
      ],
      "active_ingredient": [
        "Active ingredients Potassium Nitrate (5%)* Sodium fluoride 0.24% (0.15% w/v fluoride ion) *maximum FDA sensitivity active ingredient"
      ],
      "purpose": [
        "Purpose Antihypersensitivity Anticavity"
      ],
      "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: o apply at least a 1-inch strip of the product onto a soft bristle toothbrush. o brush teeth thoroughly for at least 1 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."
      ],
      "storage_and_handling": [
        "Other information • store below 30°C (86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, red 30, blue 1"
      ],
      "questions": [
        "Questions or comments? Call toll-free 1-800-897-5623"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 0135-0605-01 Aquafresh ® TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION triple protection ® DENTIST RECOMMENDED ACTIVE INGREDIENTS maximum strength* sensitive Sugar Acid Protection** from Fluoride • healthy gums† • strong teeth • fresh breath smooth mint NET WT 5.6 OZ (158.8 g) Aquafresh ® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth . **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack. targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity †with twice daily brushing ALWAYS FOLLOW THE LABEL Trademarks are owned by or licensed of the GSK group of companies. GSK Consumer Healthcare Warren, NJ 07059 *maximum FDA sensitivity active ingredient ©2015 GSK or its licensor. 105481XA C:\\Users\\sh821028\\Pictures\\105481XA_Aquafresh Sensitive Maximum Strength_5_6oz_cartion."
      ],
      "set_id": "76adbccb-0812-4407-a6fc-a57e6f144fbb",
      "id": "0e988328-62da-43e7-98b3-5d94a4cd6684",
      "effective_time": "20240305",
      "version": "13",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "AQUAFRESH SENSITIVE MAXIMUM STRENGTH"
        ],
        "generic_name": [
          "POTASSIUM NITRATE AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0605"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1038929"
        ],
        "spl_id": [
          "0e988328-62da-43e7-98b3-5d94a4cd6684"
        ],
        "spl_set_id": [
          "76adbccb-0812-4407-a6fc-a57e6f144fbb"
        ],
        "package_ndc": [
          "0135-0605-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}