{
  "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": "2026-07-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Devrom bismuth subgallate BISMUTH SUBGALLATE BISMUTH CATION MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN TALC XYLITOL D"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information This product cannot be expected to be effective in the reduction of odor due to faulty personal hygiene. Does not contain gluten, lactose, or salicylates.",
        "distributed by The Parthenon Company, Inc."
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Bismuth subgallate 200 mg"
      ],
      "purpose": [
        "Purpose Internal Deodorant"
      ],
      "indications_and_usage": [
        "Use for eliminating or reducing odor from flatulence (gas) and stool (feces)."
      ],
      "warnings": [
        "Warnings If pregnant or breast-feeding , ask a health professional before use. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years and over: 1 to 2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children under 12 years: ask a doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients magnesium stearate, microcrystalline cellulose, natural banana flavor. starch, talc, xylitol."
      ],
      "questions": [
        "Questions? 1-800-453-8898"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label Devrom ® (200 mg bismuth subgallate) Internal Deodarant 100 chewable tablets PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label"
      ],
      "set_id": "6a9408b1-9085-42e6-9104-c6986d5446a9",
      "id": "61d82c84-289a-4d83-a8ed-6c026f9edec9",
      "effective_time": "20241112",
      "version": "3",
      "openfda": {
        "application_number": [
          "M026"
        ],
        "brand_name": [
          "Devrom"
        ],
        "generic_name": [
          "BISMUTH SUBGALLATE"
        ],
        "manufacturer_name": [
          "The Parthenon Co., Inc."
        ],
        "product_ndc": [
          "49309-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BISMUTH SUBGALLATE"
        ],
        "rxcui": [
          "308757",
          "1942846"
        ],
        "spl_id": [
          "61d82c84-289a-4d83-a8ed-6c026f9edec9"
        ],
        "spl_set_id": [
          "6a9408b1-9085-42e6-9104-c6986d5446a9"
        ],
        "package_ndc": [
          "49309-001-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0866344000300"
        ],
        "unii": [
          "YIW503MI7V"
        ]
      }
    }
  ]
}