{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Nutralyn Multivitamin STEARIC ACID FERROUS BISGLYCINATE FERROUS CATION POTASSIUM IODIDE IODIDE ION PYRIDOXINE HYDROCHLORIDE PYRIDOXINE BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL BIOTIN BIOTIN FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION MAGNESIUM OXIDE MAGNESIUM CATION CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE MAGNESIUM STEARATE .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- MALTODEXTRIN CROSCARMELLOSE SODIUM"
      ],
      "description": [
        "Nutralyn is a prescription multivitamin/multimineral dietary supplement."
      ],
      "indications_and_usage": [
        "Nutralyn is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementa­tion, and maintenance of good health is needed."
      ],
      "contraindications": [
        "Nutralyn is contraindicated in patients with a known hypersensitivity to any of the ingredients."
      ],
      "precautions": [
        "Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."
      ],
      "warnings": [
        "WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately."
      ],
      "adverse_reactions": [
        "Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To reports adverse side effects or to obtain product information, contact Oncora Pharma at 888-321-2821."
      ],
      "dosage_and_administration": [
        "One tablet daily or as directed by a physician."
      ],
      "how_supplied": [
        "Bottles of 30 Tablets (85477-903-30). Tablet is light blue, oblong."
      ],
      "spl_unclassified_section": [
        "*Oncora Pharma does not represent this products code to be National Drug Code (NDC). Products codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies. This products is a prescription-folate with or without other dietary ingredients the - due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner(64 FR 8760). 1-3 the most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indication or claims of this product are not to be construed to be Drug claims. 1.) Federal register Notice of August 2, 1973 (39 FR 20750) 2.) Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3.) Federal register notice of March 5, 1996 (61 FR 8760) Storage and Handing"
      ],
      "storage_and_handling": [
        "STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture. TAMPER EVIDENT: Do not use if seal is broken or missing. MADE IN USA Distributed by: 888-321-2821 Oncora Pharma Dallas, TX 75161"
      ],
      "other_safety_information": [
        "KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "33da017b-1e8c-d41c-e063-6394a90aab8c",
      "id": "4aa3f835-f4aa-54bc-e063-6394a90ac250",
      "effective_time": "20260212",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Nutralyn"
        ],
        "generic_name": [
          "MULTIVITAMIN"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-903"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FERROUS BISGLYCINATE",
          "POTASSIUM IODIDE",
          "PYRIDOXINE HYDROCHLORIDE",
          "BETA CAROTENE",
          "ASCORBIC ACID",
          "CHOLECALCIFEROL",
          "BIOTIN",
          "FOLIC ACID",
          "CYANOCOBALAMIN",
          "CALCIUM CARBONATE",
          "MAGNESIUM OXIDE",
          ".ALPHA.-TOCOPHEROL ACETATE, DL-"
        ],
        "spl_id": [
          "4aa3f835-f4aa-54bc-e063-6394a90ac250"
        ],
        "spl_set_id": [
          "33da017b-1e8c-d41c-e063-6394a90aab8c"
        ],
        "package_ndc": [
          "85477-903-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193618",
          "M0001797",
          "M0022797",
          "N0000175952",
          "M0022794",
          "N0000175951"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]",
          "Vitamin D [EPC]",
          "Vitamin B12 [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]",
          "Vitamin D [CS]",
          "Vitamin B 12 [CS]"
        ],
        "unii": [
          "SFW1D987QV",
          "1C4QK22F9J",
          "68Y4CF58BV",
          "01YAE03M7J",
          "PQ6CK8PD0R",
          "1C6V77QF41",
          "6SO6U10H04",
          "935E97BOY8",
          "P6YC3EG204",
          "H0G9379FGK",
          "3A3U0GI71G",
          "WR1WPI7EW8"
        ]
      }
    }
  ]
}