{
  "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": [
        "Opal by Opalescence Original Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION GLYCERIN WATER SILICON DIOXIDE SORBITOL XYLITOL METHYL SALICYLATE POLOXAMER 407 SODIUM LAURYL SULFATE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 FD&C YELLOW NO. 5 SODIUM BENZOATE SODIUM HYDROXIDE SUCRALOSE XANTHAN GUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium Fluoride 0.25% w/w"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses 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 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. Instruct children under 6 years of age 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."
      ],
      "storage_and_handling": [
        "Other Information Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum"
      ],
      "questions": [
        "Questions or comments Call toll-free 1.800.496.8330"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton opal™ by Opalescence ® Whitening Toothpaste ORIGINAL COOL MINT FLUORIDE TOOTHPASTE NET WT. 4.7 OZ Principal Display Panel - 4.7 OZ Tube Carton"
      ],
      "set_id": "5c3bf8fc-2e8f-4a58-bcbf-e47540072a49",
      "id": "5b14e96f-d015-5738-e063-6294a90ac014",
      "effective_time": "20260909",
      "version": "6",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Opal by Opalescence Original"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Ultradent Products, Inc."
        ],
        "product_ndc": [
          "51206-312"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "1044547"
        ],
        "spl_id": [
          "5b14e96f-d015-5738-e063-6294a90ac014"
        ],
        "spl_set_id": [
          "5c3bf8fc-2e8f-4a58-bcbf-e47540072a49"
        ],
        "package_ndc": [
          "51206-312-02",
          "51206-312-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}