{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Colgate Anticavity Kit Sodium Monofluorophosphate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE WATER SORBITOL SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM PYROPHOSPHATE SACCHARIN SODIUM LIMONENE, (+/-)- SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use helps protect against cavities"
      ],
      "warnings": [
        "Warnings If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of the reach of children under 6 years of age."
      ],
      "keep_out_of_reach_of_children": [
        "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of the reach of children under 6 years of age."
      ],
      "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%\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Botrule\">adults and children 2 years of age and older</td><td styleCode=\"Lrule Botrule\">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>children 2 to 6 years</td><td styleCode=\"Lrule\">use only a pea sized amount and supervise child&apos;s brushing and rinsing (to minimize swallowing)</td></tr><tr styleCode=\"Botrule\"><td>children under 2 years</td><td styleCode=\"Lrule\">ask a dentist or physician</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin"
      ],
      "questions": [
        "Questions or comments? Call toll-free 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: label drug facts Toothbrush and tube"
      ],
      "set_id": "121decce-c364-4060-87da-0c6a6cd48474",
      "id": "457da217-6b55-47d5-e063-6394a90ab441",
      "effective_time": "20251208",
      "version": "11",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate Anticavity Kit"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Ming Fai Industrial (Shenzhen) Co. Ltd"
        ],
        "product_ndc": [
          "56153-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "457da217-6b55-47d5-e063-6394a90ab441"
        ],
        "spl_set_id": [
          "121decce-c364-4060-87da-0c6a6cd48474"
        ],
        "package_ndc": [
          "56153-001-05",
          "56153-001-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}