{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
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      "total": 184
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  "results": [
    {
      "spl_product_data_elements": [
        "Colgate Essentials SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION WATER HYDRATED SILICA SORBITOL CALCIUM PYROPHOSPHATE GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM TRIPOLYPHOSPHATE ANHYDROUS POTASSIUM PYROPHOSPHATE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM ACTIVATED CHARCOAL XANTHAN GUM COCAMIDOPROPYL BETAINE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredient Sodium monofluorophosphate 0.76% (0.10% 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=\"55%\" 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, hydrated silica, sorbitol, calcium pyrophosphate, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium saccharin, charcoal powder, xanthan gum, cocamidopropyl betaine, blue 1, red 40, yellow 5"
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 130 g Tube Carton NEW Colgate ® Anticavity Fluoride Toothpaste ESSENTIALS™ WITH CHARCOAL Daily toothpaste removes stains and impurities for whiter teeth and fresher breath NET WT 4.6 OZ (130g) ENAMEL SAFE FRESH MINT PRINCIPAL DISPLAY PANEL - 130 g Tube Carton"
      ],
      "set_id": "01c205e0-8419-47a4-ba9e-403251966ed5",
      "id": "f2ae22cc-7f47-4172-8e03-2a1de53c63ed",
      "effective_time": "20181017",
      "version": "7",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Colgate Essentials"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Mission Hills S.A de C.V"
        ],
        "product_ndc": [
          "65954-786"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "f2ae22cc-7f47-4172-8e03-2a1de53c63ed"
        ],
        "spl_set_id": [
          "01c205e0-8419-47a4-ba9e-403251966ed5"
        ],
        "package_ndc": [
          "65954-786-61",
          "65954-786-46"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}