{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Rembrandt Intense Stain Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION GLYCERIN HYDRATED SILICA WATER SORBITOL POTASSIUM PYROPHOSPHATE TITANIUM DIOXIDE SODIUM LAUROYL SARCOSINATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED LAURYL GLUCOSIDE POVIDONE, UNSPECIFIED SODIUM SULFATE COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SUCRALOSE"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride (0.243%)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental cavities."
      ],
      "warnings": [
        "Warnings"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferably after each meal or at least 2 times 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 minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor. Do not swallow."
      ],
      "other_safety_information": [
        "Other information • Store at 20°-25°C (68°-77°F). • Do not use if inner foil is torn, cut or missing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Glycerin, Hydrated Silica, Water, Sorbitol, Tetrapotassium Pyrophosphate, Flavor, Titanium Dioxide, Sodium Lauroyl Sarcosinate, Cellulose Gum, Lauryl Glucoside, PVP, Sodium Sulfate, Cocamidopropyl Betaine, Xanthan Gum, Sodium Saccharin, Sucralose."
      ],
      "questions": [
        "QUESTIONS OR COMMENTS? Email consumercare@rembrandt.com , or call 800-548-3663. Distributed by Ranir, LLC, Grand Rapids, MI 49512 ©2018 Ranir, LLC 80102AB"
      ],
      "spl_unclassified_section": [
        "Directions: updated use instructions 7/2/2019"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel I INTENSE STAIN® REMBRANDT WHITENING TOOTHPASTE WITH FLUORIDE Mint 25x MORE STAIN REMOVED IN 1 WEEK STRENGTHENS & RESTORES ENAMEL NET WT 3.5 OZ (99.2 g) rembrandt-intense-stain-carton"
      ],
      "set_id": "55dcd063-5661-35aa-e054-00144ff8d46c",
      "id": "492c5426-1082-421b-afae-a3286466683f",
      "effective_time": "20241126",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Rembrandt Intense Stain"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Ranir LLC"
        ],
        "product_ndc": [
          "66923-373"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "492c5426-1082-421b-afae-a3286466683f"
        ],
        "spl_set_id": [
          "55dcd063-5661-35aa-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "66923-373-01",
          "66923-373-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}