{
  "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",
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  "results": [
    {
      "spl_product_data_elements": [
        "Plak Smacker Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) MINT GLYCERIN ASCORBIC ACID ANHYDROUS CITRIC ACID TROLAMINE"
      ],
      "active_ingredient": [
        "Active ingredient Stannous Fluoride 0.4%"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses Helps aid in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using."
      ],
      "when_using": [
        "Warnings When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."
      ],
      "keep_out_of_reach_of_children": [
        "Warnings 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 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "Other information Do not use if the foil seal under the cap is torn, cut of missing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine"
      ],
      "questions": [
        "Questions or comments? 1-800-558-6684"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Home Care Fluoride Gel 0.4% Stannous Fluoride Creamy Mint 11421 AIDS IN THE PREVENTION OF DENTAL CAVITIES PLAK SMACKER Net Weight 4.3 oz (121.9 g) Plak_mint_image.jpg"
      ],
      "set_id": "e65fa41e-ce2e-53e4-e053-2995a90a24d2",
      "id": "42c89af1-c7d7-0ee3-e063-6394a90a3aef",
      "effective_time": "20251104",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Plak Smacker"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Young Innovations, Inc."
        ],
        "product_ndc": [
          "72796-0411"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL",
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "spl_id": [
          "42c89af1-c7d7-0ee3-e063-6394a90a3aef"
        ],
        "spl_set_id": [
          "e65fa41e-ce2e-53e4-e053-2995a90a24d2"
        ],
        "package_ndc": [
          "72796-0411-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}