FDA.reportPublic FDA data

Dialyvite

Manufacturer
Atlantic Biologicals Corps
Effective date
2017-05-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:24:10

Label at a glance#

ProductDialyvite
Active ingredientASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, COBALAMIN, BIOTIN, CALCIUM PANTOTHENATE
Label structure8 sections

Indications and uses

Dialyvite is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

Dosage and administration

Take one tablet per day or as directed by your physician, orally.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Dialyvite is a prescription folic acid supplement with additional nutrients for kidney dialysis patients.  Dialyvite is a small, round, light pink, 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

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color).


INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Dialyvite is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS

PRECAUTIONS SECTION

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 SECTION

Allergic sensitizations have been reported following oral administration of folic acid.

Consult your physician immediately if adverse side effects occur.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Take one tablet per day or as directed by your physician, orally.


HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 17856-0010

NDC: 17856-0010-4 1 TABLET, COATED in a DOSE PACK

DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0010-42020-01-31C16284748780-19d75b9d0-329b-f424-e053-dadaa90a57ceDialyvite

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0010-4Dialyvite100 in 1 CONTAINERTABLET, COATED1004
17856-0010-4Dialyvite1 in 1 DOSE PACKTABLET, COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0010DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [ATLANTIC BIOLOGICALS CORPS]4Legacy NDC, 2 package rows20170724_24d0f7d8-1409-452b-8fec-ce471e89f85e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10542-010-10EA - Each10542-010fae8b716-ac92-4d7b-9751-82a9a81a1e6612014-10-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-001017856-0010-4
10542-010

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
FOLIC ACID935E97BOY8ACTIB
COBALAMIN8406EY2OQAACTIB
BIOTIN6SO6U10H04ACTIB
CALCIUM PANTOTHENATE568ET80C3DACTIM
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
Croscarmellose SodiumM28OL1HH48IACT
Glyceryl Monostearate230OU9XXE4IACT
Starch, CornO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
Calcium Stearate776XM7047LIACT
CochinealTZ8Z31B35MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
ndc (product): 10542-010
cabe563d-b335-4224-a4e7-8a0c4f87779024d0f7d8-1409-452b-8fec-ce471e89f85e2017-05-11Adverse reactionsExact identifier
spl id: cabe563d-b335-4224-a4e7-8a0c4f877790
spl set id: 24d0f7d8-1409-452b-8fec-ce471e89f85e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.