{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "OMNI Stannous Fluoride Stannous Fluoride Fluoride Ion Ascorbic Acid Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) Anhydrous Citric Acid Glycerin Trolamine MINT"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Stannous fluoride 0.4% w/w (0.12% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental decay"
      ],
      "warnings": [
        "Warnings This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."
      ],
      "keep_out_of_reach_of_children": [
        "This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "Other information Do not freeze or expose to extreme heat. Do not use if tamper evident seal on top of box is broken or removed."
      ],
      "inactive_ingredient": [
        "Inactive ingredients ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine"
      ],
      "questions": [
        "Questions or comments? call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249"
      ],
      "package_label_principal_display_panel": [
        "Principle Display Panel Mint NDC 48878-4061-3 3M ESPE OMNI Gel™ 0.4% Stannous Fluoride Preventive Treatment Gel IMPORTANT: Read Directions thoroughly. Contents: NET WT. 4.3 oz (121.9 g) Principle Display Panel"
      ],
      "set_id": "0c2a81b1-65b5-432b-8e66-30432a245aba",
      "id": "5f88065a-e74d-4285-93d2-b208bf197523",
      "effective_time": "20240801",
      "version": "7",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "OMNI"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Solventum US LLC"
        ],
        "product_ndc": [
          "48878-4061"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "spl_id": [
          "5f88065a-e74d-4285-93d2-b208bf197523"
        ],
        "spl_set_id": [
          "0c2a81b1-65b5-432b-8e66-30432a245aba"
        ],
        "package_ndc": [
          "48878-4061-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}