{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Pronamel Repair Whitening Pronamel Repair Whitening POTASSIUM NITRATE NITRATE ION WATER SACCHARIN SODIUM TITANIUM DIOXIDE XANTHAN GUM HYDRATED SILICA SODIUM HYDROXIDE COCAMIDOPROPYL BETAINE SODIUM FLUORIDE FLUORIDE ION POLYETHYLENE GLYCOL 400 SORBITOL GLYCERIN"
      ],
      "active_ingredient": [
        "potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Antihypersensitivity Anticavity"
      ],
      "indications_and_usage": [
        "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact * aids in the prevention of dental cavities"
      ],
      "warnings": [
        "When using this product, of iffitation occurs discontine use. Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty 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 accidently swallowed, get medical help or contact a Posion 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."
      ],
      "inactive_ingredient": [
        "water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide"
      ],
      "package_label_principal_display_panel": [
        "Publix Enamel Guard Intensive"
      ],
      "set_id": "16ee2625-3641-205d-e063-6394a90a742f",
      "id": "437fb5ce-7bc7-ad3e-e063-6394a90a6b66",
      "effective_time": "20251113",
      "version": "6",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Pronamel Repair Whitening"
        ],
        "generic_name": [
          "PRONAMEL REPAIR WHITENING"
        ],
        "manufacturer_name": [
          "Publix Super Market Inc"
        ],
        "product_ndc": [
          "56062-514"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1086243"
        ],
        "spl_id": [
          "437fb5ce-7bc7-ad3e-e063-6394a90a6b66"
        ],
        "spl_set_id": [
          "16ee2625-3641-205d-e063-6394a90a742f"
        ],
        "package_ndc": [
          "56062-514-44"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041415097728"
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}