{
  "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 SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION DIBASIC CALCIUM PHOSPHATE DIHYDRATE WATER SORBITOL SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM PYROPHOSPHATE SACCHARIN SODIUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured by: COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand."
      ],
      "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 Keep out of the 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 the 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><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><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": [
        "PRINCIPAL DISPLAY PANEL - 5 g Tube Label P1536526_E Colgate ® Anticavity Toothpaste Cavity Protection NET WT 5g(0.17 oz) 2 HDPE PRINCIPAL DISPLAY PANEL - 5 g Tube Label",
        "PRINCIPAL DISPLAY PANEL - 10 g Tube Label P1536525 Colgate ® Anticavity Toothpaste Cavity Protection NET WT 10g(0.35 OZ) 2 HDPE PRINCIPAL DISPLAY PANEL - 10 g Tube Label"
      ],
      "set_id": "5bc0b430-6f68-4e52-a1da-de19136eaeac",
      "id": "80061b64-4c6c-4c58-a865-746c3eea4c3a",
      "effective_time": "20241209",
      "version": "10",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate Anticavity"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Colgate-Palmolive (Thailand) Limited - Branch"
        ],
        "product_ndc": [
          "42555-060"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "80061b64-4c6c-4c58-a865-746c3eea4c3a"
        ],
        "spl_set_id": [
          "5bc0b430-6f68-4e52-a1da-de19136eaeac"
        ],
        "package_ndc": [
          "42555-060-94",
          "42555-060-45"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}