{
  "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": [
        "OralLine Kids SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL HYDRATED SILICA WATER GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SACCHARIN SODIUM FD&C BLUE NO. 1 MINT FLAVOR OralLine Kids SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL HYDRATED SILICA WATER GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SACCHARIN SODIUM FD&C RED NO. 40 D&C RED NO. 33 Mint Flavor"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 600, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1"
      ],
      "purpose": [
        "Purpose Anticavity Toothpaste"
      ],
      "indications_and_usage": [
        "Use Use - Helps protect against cavities"
      ],
      "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 doctor. Children under 6 years of age. Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision."
      ],
      "warnings": [
        "Warnings If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep Out of Reach of Children Children under 2 years of age consult a doctor or a dentist Keep out of the reach of children under 6 years of age."
      ],
      "package_label_principal_display_panel": [
        "Product Labels OraLine Kids Fluoride Toothpaste ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed No animal based ingredients. Berry Flavor Net Wt res 003-01 113gm oraline_kids_berry 004-01 113gm 4oz BublGum 004-02 85gm 3oz BublGum"
      ],
      "set_id": "12c5bee5-e228-4f71-9bfd-c377ee2372a9",
      "id": "1076e667-505a-494a-865a-ee3767e3305e",
      "effective_time": "20250321",
      "version": "6",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "OralLine Kids"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "J.M. Murray Center Inc."
        ],
        "product_ndc": [
          "55873-003",
          "55873-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "1076e667-505a-494a-865a-ee3767e3305e"
        ],
        "spl_set_id": [
          "12c5bee5-e228-4f71-9bfd-c377ee2372a9"
        ],
        "package_ndc": [
          "55873-003-01",
          "55873-004-01",
          "55873-004-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}