{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Plak Smacker Anti Cavity Fluoride Sodium Fluoride POLYETHYLENE GLYCOL 1450 HYDRATED SILICA SACCHARIN SODIUM WATER SODIUM LAURYL SULFATE SORBITOL SODIUM FLUORIDE FLUORIDE ION POLYETHYLENE GLYCOL 300 CARBOXYMETHYLCELLULOSE PROPYLPARABEN METHYLPARABEN FD&C BLUE NO. 1 D&C RED NO. 33"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium Fluoride 0.24% (0.14% w/v Fluoride ion) Purpose Anticavity toothpaste"
      ],
      "purpose": [
        "Purpose Anticavity toothpaste",
        "Purpose Anti-Cavity Toothpaste"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental 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. Do not use if inner foil is torn, cut, or missing. Keep out of reach of children."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children.",
        "Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately."
      ],
      "do_not_use": [
        "Do not use if inner foil is torn, cut or missing."
      ],
      "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. Do not swallow To minimize swallowing use a pea sized amount in children under 6 years. Supervise children's brushing until good habits are established. Children under 2 years of age, consult a dentist or physician."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Sorbitol, Water, Hydrated silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propyparaben, Blue1, Red 33"
      ],
      "questions": [
        "Questions or comments? (800) 558-6684"
      ],
      "package_label_principal_display_panel": [
        "PLAK SMACKER® NO SUGAR ADDED DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE NET WT. 4.2 oz (119g) Dinosaur_image.jpg Dinosaur_small_image.jpg"
      ],
      "set_id": "c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe",
      "id": "07d5baa5-6b43-e0fa-e063-6394a90a9565",
      "effective_time": "20231016",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Plak Smacker Anti Cavity Fluoride"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "YOUNG PS ACQUISITION, LLC"
        ],
        "product_ndc": [
          "72326-8002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "07d5baa5-6b43-e0fa-e063-6394a90a9565"
        ],
        "spl_set_id": [
          "c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe"
        ],
        "package_ndc": [
          "72326-8002-1",
          "72326-8002-2",
          "72326-8002-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}