{
  "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": "2026-07-23",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Nicomide niacinamide, zinc glycinate, levomefolate calcium, cupric oxide, selenium and chromium ANHYDROUS LACTOSE SILICON DIOXIDE STEARIC ACID MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE TRIACETIN TITANIUM DIOXIDE CROSCARMELLOSE SODIUM HYDROXYPROPYL METHYLCELLULOSE NIACINAMIDE NIACINAMIDE ZINC GLYCINATE ZINC CATION LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID CUPRIC OXIDE CUPRIC CATION SELENIUM SELENIUM CHROMIUM CHROMIUM 342"
      ],
      "description": [
        "DESCRIPTION: Nicomide ® Tablets is a prescription dietary supplement for oral administration, specifically formulated for the dietary management of patients with unique nutritional needs who require increased levels of one or more of the ingredients in this product. Each white-colored, oval-shaped tablet is debossed with “342” on one side and blank on the other. OTHER INGREDIENTS: croscarmellose sodium, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide,stearic acid, titanium dioxide, and triacetin. Nicomide SF Panel"
      ],
      "warnings": [
        "WARNINGS WARNINGS: If you are pregnant, nursing, or taking medication, consult your doctor before use. Use only under the advice and supervision of a physician if you have a history of jaundice, liver disease or diabetes. Abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacinamide."
      ],
      "warnings_table": [
        "<table width=\"856px\"><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><content styleCode=\"bold\">WARNINGS:</content>If you are pregnant, nursing, or taking medication, consult your doctor before use. Use only under the advice and supervision of a physician if you have a history of jaundice, liver disease or diabetes. Abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacinamide. </td></tr></tbody></table>"
      ],
      "precautions": [
        "PRECAUTION: Folic acid alone is improper therapy and should not be used in treatment of pernicious anemia and other megaloblastic anemias where B 12 is deficient. Folic acid should be used with care in the presence of peptic ulcer disease, regional enteritis, and ulcerative colitis. In doses above 0.1 mg daily, folic acid may obscure the diagnosis of pernicious anemia. Please consult with your healthcare provider to determine if this dose is appropriate for you and for any anemia related questions."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION: Take 1-2 tablets daily, as a dietary supplement, as directed by your physician. Each white-colored, oval-shaped tablet is debossed with “342” on one side and blank on the other."
      ],
      "how_supplied": [
        "KEEP OUT OF THE REACH OF CHILDREN. Store at 20° -25°C (68° - 77°F); excursions permitted to 15° -30°C (59° -86°F). [See USP Controlled Room Temperature.] Do not use if seal under cap is broken or missing. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. The listed product number is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems. *Subject to one or more claims of U.S. Patent Nos. 7,582,418, 7,838,042 and 8,425,956. Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0469 Rev. 0925-01"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Nicomide BL Nicomide BL 2"
      ],
      "set_id": "799b7705-4627-4c07-8d83-52b76290af9c",
      "id": "423b62e0-e017-72f7-e063-6294a90affc5",
      "effective_time": "20251028",
      "version": "9",
      "openfda": {
        "brand_name": [
          "Nicomide"
        ],
        "generic_name": [
          "NIACINAMIDE, ZINC GLYCINATE, LEVOMEFOLATE CALCIUM, CUPRIC OXIDE, SELENIUM AND CHROMIUM"
        ],
        "manufacturer_name": [
          "Avion Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "75854-343"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NIACINAMIDE",
          "ZINC GLYCINATE",
          "LEVOMEFOLATE CALCIUM",
          "CUPRIC OXIDE",
          "SELENIUM",
          "CHROMIUM"
        ],
        "spl_id": [
          "423b62e0-e017-72f7-e063-6294a90affc5"
        ],
        "spl_set_id": [
          "799b7705-4627-4c07-8d83-52b76290af9c"
        ],
        "package_ndc": [
          "75854-343-60"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0375854343604"
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "25X51I8RD4",
          "681VJX72FE",
          "A9R10K3F2F",
          "V1XJQ704R4",
          "H6241UJ22B",
          "0R0008Q3JB"
        ]
      }
    }
  ]
}