{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "FluoriMax 5000 Sensitive 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION"
      ],
      "warnings": [
        "Warnings Section Do not swallow. Keep out of reach of children under 12 years of age. Read all the instructions and prescribing information before using this product. Do not freeze or expose to extreme heat"
      ],
      "package_label_principal_display_panel": [
        "Package label and instructions for use Primary package label"
      ],
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      "id": "ae32b0a2-e430-6a56-e053-2a95a90a0b00",
      "effective_time": "20200831",
      "version": "1",
      "openfda": {
        "brand_name": [
          "FluoriMax 5000 Sensitive"
        ],
        "generic_name": [
          "1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE"
        ],
        "manufacturer_name": [
          "Elevate Oral Care"
        ],
        "product_ndc": [
          "57511-0503"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "637365",
          "2603764"
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        "spl_id": [
          "ae32b0a2-e430-6a56-e053-2a95a90a0b00"
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        "package_ndc": [
          "57511-0503-1"
        ],
        "is_original_packager": [
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        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
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}