{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Orajel Paw Patrol Sodium fluoride CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED WATER SODIUM FLUORIDE FLUORIDE ION HYDRATED SILICA GLYCERIN STEVIA REBAUDIUNA LEAF SORBITOL COCAMIDOPROPYL BETAINE"
      ],
      "spl_patient_package_insert": [
        "Drug Facts Orajel Anti-Cavity Toothpaste"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity toothpaste"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental decay"
      ],
      "warnings": [
        "Warning 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 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 or physician"
      ],
      "dosage_and_administration_table": [
        "<table width=\"100%\" 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 or 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 www.orajelkids.com"
      ],
      "other_safety_information": [
        "Tamper Evident: Do not use if inner foil is torn, cut or missing."
      ],
      "package_label_principal_display_panel": [
        "2-10 years Orajel™ naturals nickelodeon™ PAW PATROL anti-cavity toothpaste fluoride natural fruity bubbles NET WT 4.2 OZ (119 g) Orajel Naturals Paw Patrol Tube 72036034"
      ],
      "set_id": "99d87bea-3e99-5d04-e053-2a95a90aaf54",
      "id": "5569754f-76d6-333d-e063-6294a90ab13f",
      "effective_time": "20260601",
      "version": "9",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Orajel Paw Patrol"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-786"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "5569754f-76d6-333d-e063-6294a90ab13f"
        ],
        "spl_set_id": [
          "99d87bea-3e99-5d04-e053-2a95a90aaf54"
        ],
        "package_ndc": [
          "10237-786-42",
          "10237-786-58",
          "10237-786-44"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310310320249"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}