{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Nicomide niacinamide, zinc glycinate, folic acid, cupric oxide, selenium and chromium NIACINAMIDE NIACINAMIDE ZINC GLYCINATE ZINC CATION FOLIC ACID FOLIC ACID CUPRIC OXIDE CUPRIC CATION SELENIUM SELENIUM CHROMIUM CHROMIUM HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS LACTOSE SILICON DIOXIDE STEARIC ACID MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TRIACETIN TITANIUM DIOXIDE 342" ], "statement_of_identity": [ "Rx Only Dietary Supplement 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. Supplement Facts Serving Size: 1 Tablet Amount per serving: % Daily Value Niacinamide 750 mg † Zinc (as Zinc Bisglycinate Chelate)* 27 mg 180% Folate (as (6S)-N5-Methyltetrahydrofolic Acid Calcium Salt) 500 mcg 125% Copper (as Cupric Oxide) 100% Selenium (Selenium Amino Acid Chelate) 71% Chromium (Chromium Amino Acid Chelate) 83% † Daily Value (DV) not established. OTHER INGREDIENTS Methocel K, Lactose Anhydrous, Silicon Dioxide, Stearic Acid, Microcrystalline Cellulose, Magnesium Stearate, Hydroxypropyl Methylcellulose, Triacetin, and Titanium Dioxide. INDICATIONS Nicomide ® Tablets is indicated for use as a dietary supplement for patients who are deficient in, or who are at risk for deficiency in one or more of the ingredients in this product. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "statement_of_identity_table": [ "
Supplement Facts
Serving Size: 1 Tablet
Amount per serving: % Daily Value
Niacinamide 750 mg†
Zinc (as Zinc Bisglycinate Chelate)* 27 mg180%
Folate (as (6S)-N5-Methyltetrahydrofolic Acid Calcium Salt) 500 mcg125%
Copper (as Cupric Oxide)100%
Selenium (Selenium Amino Acid Chelate) 71%
Chromium (Chromium Amino Acid Chelate) 83%
† Daily Value (DV) not established.
" ], "precautions": [ "PRECAUTIONS Large doses of Nicomide ® Tablets should be administered with caution in patients with a history of jaundice, liver disease, or diabetes. Patients with chronic liver failure and/or renal failure should exercise extreme caution in taking prescribed supplements containing copper. Folic acid alone is improper treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive. 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN." ], "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. Folate intake should not exceed 250% of the Daily Value (1,000 mcg). PREGNANCY & NURSING MOTHERS Nicomide ® Tablets is not indicated for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. Physicians and medical practitioners should administer Nicomide® Tablets with caution to patients who are pregnant, lactating and/or taking medication. ADVERSE REACTIONS Allergic sensitization has been reported rarely following oral and parental administration of Folate." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Take 1-2 tablets daily, as a dietary supplement, as directed by your physician. HOW SUPPLIED Nicomide ® Tablets are white-colored, oval-shaped tablets debossed on one side with “342”, and are supplied in bottles of 60 tablets (75854-343-60). The listed product number is not a National Drug Code. Instead, Avion has assigned a product code formatted according to standard industry practice in order to comply with the formatting requirements of pharmacy and healthcare insurance computer systems. STORAGE Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.] MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30022 1-888-61-AVION Rev. 1117-01 *Subject to one or more claims of U.S. Patent Nos. 7,582,418, 7,838,042 and 8,425,956. Nicomide ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-343-60 Nicomide ® Dietary Supplement 60 Tablets Rx Only Avion PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 30 capsules" ], "set_id": "799b7705-4627-4c07-8d83-52b76290af9c", "id": "1bdbe782-d27b-425b-b48b-c2d08daee019", "effective_time": "20231011", "version": "7", "openfda": { "brand_name": [ "Nicomide" ], "generic_name": [ "NIACINAMIDE, ZINC GLYCINATE, FOLIC ACID, CUPRIC OXIDE, SELENIUM AND CHROMIUM" ], "manufacturer_name": [ "Avion Pharmaceuticals, LLC" ], "product_ndc": [ "75854-343" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CHROMIUM", "CUPRIC OXIDE", "FOLIC ACID", "NIACINAMIDE", "SELENIUM", "ZINC GLYCINATE" ], "spl_id": [ "1bdbe782-d27b-425b-b48b-c2d08daee019" ], "spl_set_id": [ "799b7705-4627-4c07-8d83-52b76290af9c" ], "package_ndc": [ "75854-343-60" ], "is_original_packager": [ true ], "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": [ "0R0008Q3JB", "V1XJQ704R4", "935E97BOY8", "25X51I8RD4", "H6241UJ22B", "681VJX72FE" ] } } ] }