{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Colgate Maximum Cavity Protection Bubble Fruit Flavor SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM LAURYL SULFATE SACCHARIN SODIUM FD&C BLUE NO. 1 D&C YELLOW NO. 10"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use helps protect against cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally 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 accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician"
      ],
      "dosage_and_administration_table": [
        "<table width=\"65%\" styleCode=\"Noautorules\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 2 years of age and older</td><td>brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 2 to 6 years</td><td>use only a pea sized amount and supervise child&apos;s brushing and rinsing (to minimize swallowing)</td></tr><tr><td styleCode=\"Rrule\">children under 2 years</td><td>ask a dentist or physician</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10."
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 124 g Tube Label Colgate ® Anticavity Fluoride Toothpaste MAXIMUM cavity protection* BUBBLE FRUIT ® ADA Accepted American Dental Association ® NET WT 4.4 OZ (124 g) Principal Display Panel - 124 g Tube Label"
      ],
      "set_id": "0a1389f6-cac9-3d58-0744-c488abb0bbcc",
      "id": "05db5425-ea54-45c0-a50e-2d1d08fa8853",
      "effective_time": "20260303",
      "version": "9",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate Maximum Cavity Protection Bubble Fruit Flavor"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Colgate-Palmolive Company"
        ],
        "product_ndc": [
          "35000-196"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "05db5425-ea54-45c0-a50e-2d1d08fa8853"
        ],
        "spl_set_id": [
          "0a1389f6-cac9-3d58-0744-c488abb0bbcc"
        ],
        "package_ndc": [
          "35000-196-44"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}