{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0338-0190",
      "generic_name": "sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate",
      "labeler_name": "Baxter Healthcare Corporation",
      "brand_name": "TIS-U-SOL",
      "active_ingredients": [
        {
          "name": "SODIUM CHLORIDE",
          "strength": "800 mg/100mL"
        },
        {
          "name": "POTASSIUM CHLORIDE",
          "strength": "40 mg/100mL"
        },
        {
          "name": "MAGNESIUM SULFATE HEPTAHYDRATE",
          "strength": "20 mg/100mL"
        },
        {
          "name": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
          "strength": "8.75 mg/100mL"
        },
        {
          "name": "MONOBASIC POTASSIUM PHOSPHATE",
          "strength": "6.25 mg/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0338-0190-04",
          "description": "12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04)  / 1000 mL in 1 BOTTLE, PLASTIC",
          "marketing_start_date": "19820219",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "rxcui": [
          "801442",
          "801445"
        ],
        "spl_set_id": [
          "9da4121f-d62d-4da4-8dfb-0494da16015f"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X",
          "660YQ98I10",
          "SK47B8698T",
          "70WT22SF4B",
          "4J9FJ0HL51"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "IRRIGANT",
      "spl_id": "313abeef-1c8f-4fb4-9e6d-3b3737102c7e",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "IRRIGATION"
      ],
      "marketing_start_date": "19820219",
      "product_id": "0338-0190_313abeef-1c8f-4fb4-9e6d-3b3737102c7e",
      "application_number": "NDA018508",
      "brand_name_base": "TIS-U-SOL",
      "pharm_class": [
        "Calculi Dissolution Agent [EPC]",
        "Increased Large Intestinal Motility [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]",
        "Magnesium Ion Exchange Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Potassium Compounds [CS]",
        "Potassium Salt [EPC]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}