{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "UNITED Asutra TC Kit Colgate SODIUM MONOFLUOROPHOSPHATE Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE WATER SORBITOL SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SODIUM PYROPHOSPHATE SACCHARIN SODIUM SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION DIBASIC CALCIUM PHOSPHATE DIHYDRATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion) Purpose Anticavity"
      ],
      "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=\"100%\"><caption/><tbody><tr><td>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><td>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>children under 2 years</td><td>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:Kit Kit0",
        "Package Labeling: Label0 Label02"
      ],
      "set_id": "082a581a-c7e5-e614-e063-6394a90a87da",
      "id": "082a45fa-5595-1572-e063-6294a90af378",
      "effective_time": "20231020",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "UNITED Asutra TC Kit Colgate"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "MING FAI ENTERPRISE (CAMBODIA) CO., LTD"
        ],
        "product_ndc": [
          "73234-037"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "082a45fa-5595-1572-e063-6294a90af378"
        ],
        "spl_set_id": [
          "082a581a-c7e5-e614-e063-6394a90a87da"
        ],
        "package_ndc": [
          "73234-037-01",
          "42555-060-94"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}