{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Enamelon stannous fluoride GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) COCAMIDOPROPYL BETAINE CALCIUM SULFATE POLOXAMER 407 DIMETHICONE LAUROYL SARCOSINE TITANIUM DIOXIDE ACESULFAME POTASSIUM SODIUM PHOSPHATE, MONOBASIC SUCRALOSE STANNOUS FLUORIDE FLUORIDE ION Mint Breeze"
      ],
      "active_ingredient": [
        "Active ingredient Stannous fluoride 0.45% (0.16% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity/Sensitivity Relief/Antigingivitis"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of cavities Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact Helps prevent gingivitis Helps interfere with the harmful effects of plaque associated with gingivitis"
      ],
      "keep_out_of_reach_of_children": [
        "Warnings Keep out of the reach of children under 6 years of age."
      ],
      "warnings": [
        "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."
      ],
      "spl_unclassified_section": [
        "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. Do not use if foil seal on tube is broken or missing Keep tightly closed when not in use Store at controlled room temperature",
        "Distributed By Premier ® Dental Products Company, Plymouth Meeting, PA 19462 www.premusa.com Part # 9007280 www.enamelon.com United States Patent Numbers : US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A. Ultramulsion ® is a registered trademark of WhiteHill Oral Technologies, Inc."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Glycerin, polyethylene glycol, silica, calcium/sodium maleate methyl vinyl ether copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, titanium dioxide, flavor, acesulfame k, monosodium phosphate, sucralose"
      ],
      "questions": [
        "Questions or comments? Call toll-free 1-888-670-6100 Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL STRENGTHEN YOUR SMILE! ACP TM Enamel Therapy Premier ® Enamelon ® Mint Breeze Fluoride Toothpaste NET WT 4.3 OZ (122 g) For Anticavity, Antigingivitis & Sensitive Teeth HYDRAMULSION ® NDC 48783-520-43 Enamelon Toothpaste Box"
      ],
      "set_id": "1626375a-f78b-4192-b7f3-ca932acab7fb",
      "id": "4847e71b-2083-917b-e063-6394a90a2df0",
      "effective_time": "20260113",
      "version": "7",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Enamelon"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Premier Dental Products Company"
        ],
        "product_ndc": [
          "48783-520"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "4847e71b-2083-917b-e063-6394a90a2df0"
        ],
        "spl_set_id": [
          "1626375a-f78b-4192-b7f3-ca932acab7fb"
        ],
        "package_ndc": [
          "48783-520-43"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}