{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "SparkleFresh Flouride Toothpaste Sodium Monofluorophosphate WATER SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION METHYLPARABEN SODIUM SILICATE SACCHARIN SODIUM SACCHARIN TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 PROPYLPARABEN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CALCIUM CARBONATE SODIUM LAURYL SULFATE SORBITOL SODIUM PYROPHOSPHATE"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Monofluorophosphate 0.76%"
      ],
      "purpose": [
        "Purpose Anticavity toothpaste"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately."
      ],
      "dosage_and_administration": [
        "Directions adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician 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 physician"
      ],
      "inactive_ingredient": [
        "Inactive ingredients calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben"
      ],
      "spl_unclassified_section": [
        "Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in India www.medline.com 1-800-MEDLINE (633-5463) REF: NONTP15I RH22NWI"
      ],
      "package_label_principal_display_panel": [
        "Package Label Label RH22NWI"
      ],
      "set_id": "1565528b-89f2-4c97-b294-15b6ebd3f80e",
      "id": "27d69435-782e-9b40-e063-6394a90a93f4",
      "effective_time": "20241126",
      "version": "7",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "SparkleFresh Flouride Toothpaste"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-083"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "27d69435-782e-9b40-e063-6394a90a93f4"
        ],
        "spl_set_id": [
          "1565528b-89f2-4c97-b294-15b6ebd3f80e"
        ],
        "package_ndc": [
          "53329-083-21",
          "53329-083-92",
          "53329-083-93",
          "53329-083-94"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}