{
  "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": "2026-05-12",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc Ascorbic Acid Ascorbic Acid Thiamine Mononitrate Thiamine Ion Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Cobalamin Cobalamin Biotin Biotin Calcium Pantothenate Pantothenic Acid Zinc Citrate Zinc Cation Microcrystalline Cellulose Croscarmellose Sodium Glyceryl Monostearate Shellac Starch, Corn Calcium Stearate H"
      ],
      "description": [
        "DESCRIPTION Dialyvite with Zinc is a prescription folic acid supplement with zinc and additional nutrients for kidney dialysis patients. Dialyvite with Zinc is a small, round, yellow, clear-coated tablet, with debossed \"H\" on one side. Each tablet contains: Folic Acid.....1 mg Vitamin C (Ascorbic Acid).....100 mg Thiamine (Thiamine Mononitrate).....1.5 mg Riboflavin.....1.7 mg Niacinamide.....20 mg Vitamin B6 (Pyridoxine HCl).....10 mg Vitamin B12 (Methylcobalamin).....6 mcg Biotin.....300 mcg Pantothenic Acid (Calcium Pantothenate).....10 mg Zinc (Zinc Citrate).....50 mg Inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Calcium Stearate."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Dialyvite with Zinc is a prescription folic acid supplement with Zinc and additional nutrients indicated for use in improving the nutritional status of renal dialysis patients."
      ],
      "contraindications": [
        "CONTRAINDICATIONS This product is contraindicated in patients with known hypersensitivity to any of the ingredients."
      ],
      "precautions": [
        "PRECAUTIONS Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress. Keep out of reach of children."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Take one tablet per day or as directed by your physician, orally."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 10542-012-10 Dialyvite with Zinc Multivitamin Supplement for Dialysis Patients 100 Tablets Dialyvite with Zinc PDP"
      ],
      "set_id": "06508e37-5ae6-4a17-bf60-b3828c6082a7",
      "id": "d9913eda-a019-4227-9dd3-9e8358dec165",
      "effective_time": "20260127",
      "version": "5",
      "openfda": {
        "brand_name": [
          "Dialyvite with Zinc"
        ],
        "generic_name": [
          "ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC"
        ],
        "manufacturer_name": [
          "Hillestad Pharmaceuticals USA"
        ],
        "product_ndc": [
          "10542-012"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ASCORBIC ACID",
          "BIOTIN",
          "CALCIUM PANTOTHENATE",
          "COBALAMIN",
          "FOLIC ACID",
          "NIACINAMIDE",
          "PYRIDOXINE HYDROCHLORIDE",
          "RIBOFLAVIN",
          "THIAMINE MONONITRATE",
          "ZINC CITRATE"
        ],
        "spl_id": [
          "d9913eda-a019-4227-9dd3-9e8358dec165"
        ],
        "spl_set_id": [
          "06508e37-5ae6-4a17-bf60-b3828c6082a7"
        ],
        "package_ndc": [
          "10542-012-10",
          "10542-012-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0105420121004"
        ],
        "nui": [
          "N0000193618",
          "M0001797"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]"
        ],
        "unii": [
          "PQ6CK8PD0R",
          "6SO6U10H04",
          "568ET80C3D",
          "8406EY2OQA",
          "935E97BOY8",
          "25X51I8RD4",
          "68Y4CF58BV",
          "TLM2976OFR",
          "8K0I04919X",
          "K72I3DEX9B"
        ]
      }
    }
  ]
}