{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT STANNOUS FLUORIDE STANNOUS FLUORIDE FLUORIDE ION GLYCERIN WATER HYDRATED SILICA SORBITOL SODIUM LAURYL SULFATE SODIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POTASSIUM NITRATE SACCHARIN SODIUM XANTHAN GUM COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredient Stannous Fluoride 0.454% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purposes Anticavity, Antigingivitis, Antisensitivity"
      ],
      "indications_and_usage": [
        "Uses aids in the prevention of cavities helps prevent gingivitis helps interfere with harmful effects of plaque associated with gingivitis builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact"
      ],
      "warnings": [
        "Warnings When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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. Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease."
      ],
      "when_using": [
        "When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist."
      ],
      "stop_use": [
        "Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.",
        "Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease."
      ],
      "keep_out_of_reach_of_children": [
        "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."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult a dentist."
      ],
      "storage_and_handling": [
        "Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. this Colgate product is specially formulated to help prevent staining."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Glycerin, Water, Hydrated Silica, Sorbitol, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Cellulose Gum, Potassium Nitrate, Sodium Saccharin, Xanthan Gum, Cocamidopropyl Betaine, Titanium Dioxide."
      ],
      "questions": [
        "Questions? 1-800-468-6502"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 24.9 g Tube Carton Colgate ® Anticavity, Antigingivitis and Antisensitivity Toothpaste CLEAN MINT PASTE CLINICALLY PROVEN ANTIBACTERIAL 24 HOURS 1 ADA Accepted American Dental Association ® Total ACTIVE PREVENTION NET WT 0.88 OZ (24.9 g) Fight Root Cause † of: Gingivitis ✓ Plaque ✓ Tartar ✓ Cavities ✓ Sensitivity ✓ Bad Breath ✓ Enamel Erosion ✓ Stains ✓ Principal Display Panel - 24.9 g Tube Carton"
      ],
      "set_id": "178d4535-fa57-4b53-b1f8-5c591f2ea9e7",
      "id": "cadd20c6-0923-4922-ba0d-fa6c6afea457",
      "effective_time": "20260821",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Colgate-Palmolive Company"
        ],
        "product_ndc": [
          "35000-431"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "cadd20c6-0923-4922-ba0d-fa6c6afea457"
        ],
        "spl_set_id": [
          "178d4535-fa57-4b53-b1f8-5c591f2ea9e7"
        ],
        "package_ndc": [
          "35000-431-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}