{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Colgate Revitalizing White Sodium Monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION WATER SORBITOL HYDRATED SILICA CALCIUM PYROPHOSPHATE GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM TRIPOLYPHOSPHATE ANHYDROUS POTASSIUM PYROPHOSPHATE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XANTHAN GUM ACTIVATED CHARCOAL SACCHARIN SODIUM COCAMIDOPROPYL BETAINE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: COLGATE-PALMOLIVE CO. New York, NY 10022 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredient Sodium Monofluorophosphate 0.76% (0.10% 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 align=\"left\" width=\"30%\" valign=\"top\"/><col align=\"left\" width=\"70%\" 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 Water, Sorbitol, Hydrated Silica, Calcium Pyrophosphate, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Xanthan Gum, Charcoal Powder, Sodium Saccharin, Cocamidopropyl Betaine, Blue 1, Red 40, Yellow 5."
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 130 g Tube Carton Colgate ® Anticavity Fluoride Toothpaste REVITALIZING WHITE whitening toothpaste with activated charcoal Recyclable Tube NET WT 4.6 OZ (130 g) FRESH MINT PRINCIPAL DISPLAY PANEL - 130 g Tube Carton"
      ],
      "set_id": "c67223ae-b068-41c5-a15b-7ae9840b93ef",
      "id": "22a56e6d-1b58-466a-b172-7a71181168be",
      "effective_time": "20260527",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate Revitalizing White"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Colgate-Palmolive Company"
        ],
        "product_ndc": [
          "35000-017"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "22a56e6d-1b58-466a-b172-7a71181168be"
        ],
        "spl_set_id": [
          "c67223ae-b068-41c5-a15b-7ae9840b93ef"
        ],
        "package_ndc": [
          "35000-017-46"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}