{
  "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": [
        "parodontax Complete Protection stannous fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) COCAMIDOPROPYL BETAINE SACCHARIN SODIUM"
      ],
      "active_ingredient": [
        "Active ingredient Stannous fluoride 0.454% (0.15%w/v fluoride ion)"
      ],
      "purpose": [
        "Purposes Anticavity, Antigingivitis"
      ],
      "indications_and_usage": [
        "Uses • aids in the prevention of dental cavities. • helps control 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."
      ],
      "stop_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 • adults and children 2 years of age and older: • apply toothpaste onto a toothbrush. • brush teeth thoroughly, preferably after each meal at least twice a day, or as directed by a dentist or doctor. Minimize swallowing. • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "Other information • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. • this product is specially formulated to help prevent staining. • do not store above 25ºC (77ºF)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine"
      ],
      "questions": [
        "Questions or comments? Call toll-free 1-866-844-2797"
      ],
      "spl_unclassified_section": [
        "Additional Information ALWAYS FOLLOW THE LABEL parodontax COMPLETE PROTECTION Bleeding, redness, and swelling can be signs of unhealthy gums, eventually weakening the foundation of your teeth. parodontax Complete Protection builds on the gum health expertise behind our dentist recommended daily fluoride toothpaste – providing 8 benefits designed for healthy gums and strong teeth. With a fresh minty flavor to enjoy every day. 8 BENEFITS FOR HEALTHY GUMS & STRONG TEETH Gently whitens Deep cleans Helps prevent bleeding gums Effectively removes plaque Strengthens and protects enamel Freshens breath Works to keep the seal between gums and teeth tight Reduces red and inflamed gums"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel DENTIST RECOMMENDED parodontax TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION PURE FRESH MINT COMPLETE PROTECTION 8 BENEFITS ✓ REDUCES BLEEDING GUMS ✓ REDUCES INFLAMED GUMS ✓ GUM SEAL ✓ REMOVES PLAQUE ✓ STRENGHTENS ENAMEL ✓ DEEP CLEANS ✓ WHITENS ✓ FRESHENS BREATH NET WT 3.4 OZ (96.4 g) Parodontax Pure Complete Protection Fresh Mint 3.4 oz"
      ],
      "set_id": "59bb84d6-6fd3-4586-bccf-7dc45cbbb39c",
      "id": "3dceeb8e-b90f-4f13-9b47-999695738b9b",
      "effective_time": "20251222",
      "version": "8",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "parodontax Complete Protection"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0627"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "rxcui": [
          "416784"
        ],
        "spl_id": [
          "3dceeb8e-b90f-4f13-9b47-999695738b9b"
        ],
        "spl_set_id": [
          "59bb84d6-6fd3-4586-bccf-7dc45cbbb39c"
        ],
        "package_ndc": [
          "0135-0627-02",
          "0135-0627-03",
          "0135-0627-01",
          "0135-0627-04",
          "0135-0627-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}