FDA.reportPublic FDA data

Dialyvite Supreme D

Manufacturer
Hillestad Pharmaceuticals USA
Effective date
2026-01-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 21:58:02

Label at a glance#

ProductDialyvite Supreme D
Active ingredientAscorbic Acid, Cholecalciferol, .alpha.-tocopherol succinate, d-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cobalamin, Biotin, Calcium Pantothenate, Zinc Citrate, Selenocysteine
Label structure7 sections

Indications and uses

Dialyvite Supreme D 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 or as directed by your physician, orally.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Dialyvite Supreme D is a prescription folic acid supplement with additional nutrients for kidney dialysis patients.  Dialyvite Supreme D is a small, round, light green, coated tablet, with debossed "H" on one side, and bisected on the other side.

Each tablet contains:

Folic Acid.....3 mg

Vitamin C (Ascorbic Acid).....100 mg

Vitamin D (Cholecalciferol).....2000 IU

Vitamin E (D-alpha-Tocopheryl Acid Succinate).....30 IU

Thiamine Mononitrate.....1.5 mg

Riboflavin.....1.7 mg

Niacinamide.....20 mg

Vitamin B6 (Pyridoxine HCl).....25 mg

Vitamin B12 (Methylcobalamin).....1 mg

Biotin.....300 mcg

Pantothenic Acid (Calcium Pantothenate).....10 mg

Zinc (Zinc Citrate).....15 mg

Selenium (Selenium Amino Acid Chelate).....70 mcg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Pharmaceutical Glaze, Starch, Silicon Dioxide, Calcium Stearate, Chlorophyllin (color).

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Dialyvite Supreme D 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 or as directed by your physician, orally.


PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10542-009-09

Dialyvite Supreme D

Multivitamin Supplement for Dialysis Patients

90 Tablets


Dialyvite Supreme D PDPDialyvite Supreme D PDP

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130105420090904GTIN-13: 0105420090904
EAN-13: 0105420090904
GTIN-12: 105420090904
UPC-A: 105420090904
GTIN storage (14 digits): 00105420090904		LabelHP09(rev.7).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10542-009-02Dialyvite Supreme D7 in 1 BOTTLE, PLASTICTABLET, COATED79
10542-009-09Dialyvite Supreme D90 in 1 BOTTLE, PLASTICTABLET, COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10542-009-09EA - Each10542-0099a5d15ce-d1dd-4485-9c7d-78d8a958a6f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Alpha-Tocopherol Succinate, D-ACTIVE INGREDIENTLU4B53JYVE4
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R4
BiotinACTIVE INGREDIENT6SO6U10H044
Calcium PantothenateACTIVE INGREDIENT568ET80C3D4
CholecalciferolACTIVE INGREDIENT1C6V77QF414
CobalaminACTIVE INGREDIENT8406EY2OQA4
Folic AcidACTIVE INGREDIENT935E97BOY84
NiacinamideACTIVE INGREDIENT25X51I8RD44
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV4
RiboflavinACTIVE INGREDIENTTLM2976OFR4
SeleniumACTIVE INGREDIENTH6241UJ22B4
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X4
Zinc CitrateACTIVE INGREDIENTK72I3DEX9B4
Alpha-TocopherolACTIVE MOIETYH4N855PNZ14
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R4
BiotinACTIVE MOIETY6SO6U10H044
CholecalciferolACTIVE MOIETY1C6V77QF414
CobalaminACTIVE MOIETY8406EY2OQA4
Folic AcidACTIVE MOIETY935E97BOY84
NiacinamideACTIVE MOIETY25X51I8RD44
Pantothenic AcidACTIVE MOIETY19F5HK27374
PyridoxineACTIVE MOIETYKV2JZ1BI6Z4
RiboflavinACTIVE MOIETYTLM2976OFR4
SeleniumACTIVE MOIETYH6241UJ22B4
ThiamineACTIVE MOIETYX66NSO3N354
ZincACTIVE MOIETYJ41CSQ7QDS4
Calcium StearateINACTIVE INGREDIENT776XM7047L4
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U4
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH484
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE44
ShellacINACTIVE INGREDIENT46N107B71O4
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU44
Sodium Copper ChlorophyllinINACTIVE INGREDIENT1D276TYV9O4
Starch, CornINACTIVE INGREDIENTO8232NY3SJ4

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10542-00910542-009-09, 10542-009-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Ascorbic AcidPQ6CK8PD0RACTIB
Cholecalciferol1C6V77QF41ACTIB
.alpha.-tocopherol succinate, d-LU4B53JYVEACTIM
Thiamine Mononitrate8K0I04919XACTIR
RiboflavinTLM2976OFRACTIB
Niacinamide25X51I8RD4ACTIB
Pyridoxine Hydrochloride68Y4CF58BVACTIB
Folic Acid935E97BOY8ACTIB
Cobalamin8406EY2OQAACTIB
Biotin6SO6U10H04ACTIB
Calcium Pantothenate568ET80C3DACTIM
Zinc CitrateK72I3DEX9BACTIM
Selenocysteine0CH9049VISACTIM
Microcrystalline CelluloseOP1R32D61UIACT
Croscarmellose SodiumM28OL1HH48IACT
Glyceryl Monostearate230OU9XXE4IACT
Shellac46N107B71OIACT
Starch, CornO8232NY3SJIACT
Silicon DioxideETJ7Z6XBU4IACT
Calcium Stearate776XM7047LIACT
Sodium Copper Chlorophyllin1D276TYV9OIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route
30 equally ranked IID candidates
Calcium StearateCALCIUM STEARATE776XM7047LTABLET, COATED / ORAL12.2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ShellacSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Calcium StearateCALCIUM STEARATE776XM7047LTABLET, COATED / ORAL12.2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route
30 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii+route
30 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route
30 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii+route
30 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii+route
30 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii+route
30 equally ranked IID candidates
Calcium StearateCALCIUM STEARATE776XM7047LTABLET, COATED / ORAL12.2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ShellacSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii+route
30 equally ranked IID candidates
ShellacSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route
30 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii+route
30 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route
30 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dialyvite Supreme DASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA46fc3acf-1e6d-4830-ae9a-abd9c1132fca2026-01-27Adverse reactionsExact identifier
ndc (package): 10542-009-02
ndc (package): 10542-009-09
ndc (product): 10542-009
ndc11 (package): 10542000909
ndc11 (package): 10542000902
spl id: e4c39ddd-ac1c-48f2-8251-6b6fe4f570a9
spl set id: 46fc3acf-1e6d-4830-ae9a-abd9c1132fca

Reported adverse events (FAERS/openFDA)#

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