{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Colgate MaxFresh Knockout Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM SODIUM PYROPHOSPHATE COCAMIDOPROPYL BETAINE HYPROMELLOSE, UNSPECIFIED FD&C BLUE NO. 1 TITANIUM DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: COLGATE-PALMOLIVE CO. 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=\"75%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" 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, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide."
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 170 g Tube Carton Colgate ® Anticavity Fluoride Toothpaste 10x LONGER LASTING COOL † MaxFresh ® WITH WHITENING KNOCKOUT ® FIGHTS BAD BREATH AND FOOD AFTERTASTES ‡ MINT FUSION ® Recyclable Tube NET WT 6.0 OZ (170 g) PRINCIPAL DISPLAY PANEL - 170 g Tube Carton"
      ],
      "set_id": "b6ca4ec7-5087-4693-82b7-199b44d7f931",
      "id": "aa4c35c1-54b0-42a0-abec-a41932c0821c",
      "effective_time": "20241113",
      "version": "14",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate MaxFresh Knockout"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "COLGATE PALMOLIVE COMPANY"
        ],
        "product_ndc": [
          "35000-127"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "aa4c35c1-54b0-42a0-abec-a41932c0821c"
        ],
        "spl_set_id": [
          "b6ca4ec7-5087-4693-82b7-199b44d7f931"
        ],
        "package_ndc": [
          "35000-127-60",
          "35000-127-74",
          "35000-127-95",
          "35000-127-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}