{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "AMERFRESH FLUORIDE Sodium Fluoride SACCHARIN SODIUM SORBITOL SODIUM CARBONATE HYDRATED SILICA SODIUM LAURYL SULFATE WATER HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) METHYLPARABEN PROPYLPARABEN SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredients Sodium Fluoride 0.22%(0.1 w/v Fluoride ion) Purpose anticavity toothpaste"
      ],
      "purpose": [
        "Purpose anticavity toothpaste"
      ],
      "indications_and_usage": [
        "Uses 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 accidently swallowed,get medical help or contact a Poison Control Center immediately. Keep out of reach of children."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions do not swallow supervise children as necessary until capable of useing without supervision instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing). Adults and children 6 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 a physician. Children under 6 years of age:do not use unless directed by a doctor or dentist."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENT Calcium Carbonate, Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Hydroypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben"
      ],
      "package_label_principal_display_panel": [
        "image description"
      ],
      "set_id": "827e45bb-84c0-48ee-a60b-2cc32b8f33e3",
      "id": "2bce0fcd-1d50-cf52-e063-6394a90a3603",
      "effective_time": "20250116",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "AMERFRESH FLUORIDE"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Yangzhou ONE & ONLY Personal Care Products Co., LTD"
        ],
        "product_ndc": [
          "85162-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "245598"
        ],
        "spl_id": [
          "2bce0fcd-1d50-cf52-e063-6394a90a3603"
        ],
        "spl_set_id": [
          "827e45bb-84c0-48ee-a60b-2cc32b8f33e3"
        ],
        "package_ndc": [
          "85162-002-01",
          "85162-002-02",
          "85162-002-03",
          "85162-002-04",
          "85162-002-05",
          "85162-002-06",
          "85162-002-07"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}