{
  "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 OPTIC WHITE ADVANCED VIBRANT CLEAN SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION PROPYLENE GLYCOL CALCIUM PYROPHOSPHATE POVIDONE K15 PEG/PPG-116/66 COPOLYMER POLYETHYLENE GLYCOL 600 GLYCERIN HYDROGEN PEROXIDE SODIUM LAURYL SULFATE SILICON DIOXIDE SODIUM PYROPHOSPHATE SACCHARIN SODIUM SODIUM ACID PYROPHOSPHATE SUCRALOSE BUTYLATED HYDROXYTOLUENE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredient Sodium Monofluorophosphate 1.14% (0.19% 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 6 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 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 6 years do not use unless directed by 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 Toprule\"><td styleCode=\"Rrule\">adults and children 6 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 6 to 12 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 6 years</td><td>do not use unless directed by a dentist or physician</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT."
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 127 g Tube Carton Colgate ® Anticavity Fluoride Toothpaste NOW 2X WHITENING INGREDIENT † OPTIC WHITE ® ADVANCED DEEPLY WHITENS FOR UP TO FOUR SHADES* HYDROGEN 2 % PEROXIDE ENAMEL SAFE NET WT 4.5 OZ (127 g) VIBRANT CLEAN PRINCIPAL DISPLAY PANEL - 127 g Tube Carton"
      ],
      "set_id": "ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3",
      "id": "4953d031-17cb-47e3-9d35-2358e62927ee",
      "effective_time": "20251021",
      "version": "5",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Colgate-Palmolive Company"
        ],
        "product_ndc": [
          "35000-979"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "1038995"
        ],
        "spl_id": [
          "4953d031-17cb-47e3-9d35-2358e62927ee"
        ],
        "spl_set_id": [
          "ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3"
        ],
        "package_ndc": [
          "35000-979-32",
          "35000-979-86",
          "35000-979-76",
          "35000-979-78"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}