{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Therabreath Deep Clean Stannous fluoride STANNOUS FLUORIDE FLUORIDE ION WATER HYDRATED SILICA GLYCERIN PENTASODIUM TRIPHOSPHATE CROSPOVIDONE, UNSPECIFIED PEG-8 SILICON DIOXIDE SUCRALOSE TITANIUM DIOXIDE SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE XANTHAN GUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Stannous fluoride 0.454% (0.14% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity/Antigingivitis"
      ],
      "indications_and_usage": [
        "Uses • aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis"
      ],
      "warnings": [
        "Warnings Stop use and ask a dentist if • gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. 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."
      ],
      "do_not_use": [
        "Stop use and ask a dentist if • gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease."
      ],
      "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 • do not swallow • supervise children as necessary until capable of using without supervision 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 children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years of age consult a dentist or doctor"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\" cellpadding=\"2\" width=\"60%\"><tbody><tr><td>adults and children 2 years of age and older</td><td>brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor</td></tr><tr><td>children under 6 years of age</td><td>instruct in good brushing and rinsing habits (to minimize swallowing)</td></tr><tr><td>children under 2 years of age</td><td>consult a dentist or doctor</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients water, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, silica, sodium lauryl sulfate, flavor, sodium lauroyl sarcosinate, polyvinylpyrrolidone, titanium dioxide, xanthan gum, sucralose"
      ],
      "questions": [
        "Questions or Comments? Therabreath™ is manufactured by Church & Dwight Co., Inc., Ewing, NJ 02628 U.S.A. Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel LONG LASTING FOR EPIC FRESHNESS TheraBreath™ DEEP CLEAN DENTIST FORMULATED TOOTHPASTE Anticavity/Antigingivitus KILLS 99.9% OF GERMS THAT CAUSE BAD BREATH, PLAQUE, AND GINGIVITIS* TWIN PACK *in laboratory tests Neutralizes the source of bad breath* *in laboratory tests Gently whitens Dr. Harold Katz Fresh Mint 2 TUBES of 4.0 oz (113 g) TOTAL NET WT. 8.0 oz (226 g) TB Toothpaste Deep Clean 4 oz Twin Carton TB Deep Clean 4oz Toothpaste Tube"
      ],
      "set_id": "3c372f26-e0c4-0659-e063-6294a90ae9f9",
      "id": "59905b26-6316-4aee-e063-6394a90a019f",
      "effective_time": "20260821",
      "version": "2",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Therabreath Deep Clean"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-270"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "59905b26-6316-4aee-e063-6394a90a019f"
        ],
        "spl_set_id": [
          "3c372f26-e0c4-0659-e063-6294a90ae9f9"
        ],
        "package_ndc": [
          "10237-270-24",
          "10237-270-04",
          "10237-270-07"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}