{
  "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,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Antigingivitis/Antiplaque Cetylpyridinium Chloride WATER GLYCERIN ZINC LACTATE BENZOIC ACID SACCHARIN SODIUM SUCRALOSE SODIUM BENZOATE POLOXAMER 407 CINNAMALDEHYDE FD&C BLUE NO. 1 CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM"
      ],
      "spl_unclassified_section": [
        "Tamper Evident Statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION",
        "Claims Kroger ® GUM DEFENSE ANTIGINGIVITIS ANTIPLAQUE MOUTH RINSE",
        "Other information this rinse is not intended to replace brushing or flossing",
        "Disclaimers This may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence. *Crest ® and Pro-Health ® are registered trademarks of the Proctor & Gamble Co."
      ],
      "active_ingredient": [
        "Active Ingredient Cetylpyridinium Chloride 0.07%"
      ],
      "purpose": [
        "Purpose Antigingivitis, Antiplaque"
      ],
      "indications_and_usage": [
        "Use helps control plaque that leads to gingivitis"
      ],
      "warnings": [
        "Warnings For this product"
      ],
      "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 increased 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 rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushing, rinse mouth with water first children under 6 years of age: do not use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1"
      ],
      "questions": [
        "Questions or Comments? Call 1-800-632-6900"
      ],
      "adverse_reactions": [
        "ADVERSE REACTION PROUDLY DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202 MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS. Quality Guaranteed Kroger.com/guarantee 800-632-6900"
      ],
      "package_label_principal_display_panel": [
        "Principal Panel Display COMPARE TOCREST ® PRO-HEALTH ® BREATHPURIFY AND GUM CARE ORAL RINSE SEE BACK LABEL* Kroger ® GUM DEFENSE ANTIGINGIVITIS • ANTIPLAQUE MOUTH RINSE ALCOHOL-FREE SMOOTH MINT KILLS GERMS THAT CAUSE BAD BREATH HELPS DEFEND AGAINST EARLY SIGNS OF GUM DISEASE HELPS IMPROVE GUM HYGIENE QUALITY GUARANTEED 33.8 FL OZ (1.05 QT) 1 L image description image description"
      ],
      "set_id": "922bff32-7536-4a6d-b04b-0b02f14fbecc",
      "id": "4bd21344-e34f-9f71-e063-6294a90aec5b",
      "effective_time": "20260227",
      "version": "5",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Antigingivitis/Antiplaque"
        ],
        "generic_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "The Kroger Co."
        ],
        "product_ndc": [
          "59450-997"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "rxcui": [
          "1100924"
        ],
        "spl_id": [
          "4bd21344-e34f-9f71-e063-6294a90aec5b"
        ],
        "spl_set_id": [
          "922bff32-7536-4a6d-b04b-0b02f14fbecc"
        ],
        "package_ndc": [
          "59450-997-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "D9OM4SK49P"
        ]
      }
    }
  ]
}