{
  "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,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Colgate Optic White Stain Fighter With Baking Soda SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POTASSIUM HYDROXIDE SODIUM PYROPHOSPHATE PHOSPHORIC ACID COCAMIDOPROPYL BETAINE BENZYL ALCOHOL SACCHARIN SODIUM SODIUM BICARBONATE"
      ],
      "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=\"60%\" 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 Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Sodium Bicarbonate."
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 85 g Tube Carton Colgate ® Anticavity Fluoride Toothpaste Clean Mint Paste ENAMEL SAFE Removes 95% of Daily Surface Stains* with Micro-Polishing Action OPTIC WHITE ® STAIN FIGHTER ® with Baking Soda NET WT 3.0 OZ (85 g) Principal Display Panel"
      ],
      "set_id": "8e6113e2-101b-4bde-90e9-6ab32c6ebf5c",
      "id": "6b8c76b7-89f3-4e27-91cb-c4bb2f06aaed",
      "effective_time": "20260805",
      "version": "8",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate Optic White Stain Fighter With Baking Soda"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Colgate-Palmolive Company"
        ],
        "product_ndc": [
          "35000-809"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "6b8c76b7-89f3-4e27-91cb-c4bb2f06aaed"
        ],
        "spl_set_id": [
          "8e6113e2-101b-4bde-90e9-6ab32c6ebf5c"
        ],
        "package_ndc": [
          "35000-809-60",
          "35000-809-42",
          "35000-809-63",
          "35000-809-59",
          "35000-809-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}