{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Orajel KidsToothpaste Sodium fluoride SORBITOL WATER HYDRATED SILICA GLYCERIN CELLULOSE GUM COCAMIDOPROPYL BETAINE STEVIA REBAUDIANA LEAF SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts Orajel Mermaid and Unicorn Anti-cavity Toothpaste"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental decay"
      ],
      "warnings": [
        "Warnings Keep out of 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."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of 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."
      ],
      "dosage_and_administration": [
        "Directions • twist off cap and remove foil seal • do not swallow • supervise children as necessary until capable of using without supervision adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist of physician"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\"><tbody><tr><td>adults and children 2 years and older</td><td>brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician</td></tr><tr><td>children under 6 years</td><td>instruct in good brushing and rinsing habits (to minimize swallowing)</td></tr><tr><td>children under 2 years</td><td>ask a dentist of physician</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, Stevia rebaudiana leaf extract, natural flavor"
      ],
      "questions": [
        "Questions or comments? Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at orajelkids.com"
      ],
      "other_safety_information": [
        "Tamper Evident: Do not use if inner foil is torn, cut or missing."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel 2-10 years Orajel™ naturals magical unicorns OR mermaid anti-cavity toothpaste fluoride protects against cavities, helps strengthen enamel and keep gums healthy NET WT 4.2 OZ (119 g) Orajel Naturals Unicorn Toothpaste Tube 72036038"
      ],
      "set_id": "99d62125-c2c5-5926-e053-2995a90aaa29",
      "id": "557a7351-42a8-5c23-e063-6294a90a5cf2",
      "effective_time": "20260601",
      "version": "7",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Orajel KidsToothpaste"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-785"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "557a7351-42a8-5c23-e063-6294a90a5cf2"
        ],
        "spl_set_id": [
          "99d62125-c2c5-5926-e053-2995a90aaa29"
        ],
        "package_ndc": [
          "10237-785-42"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}