FDA.reportPublic FDA data

NICAPRIN

Manufacturer
Artesa Labs, LLC
Effective date
2016-09-23
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:20

Label at a glance#

ProductNICAPRIN
Active ingredientNIACIN, FOLIC ACID, CUPRIC OXIDE, ZINC OXIDE, PYRIDOXINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

This product is indicated for patients who are deficient in, or at risk of deficiency in, one or more of the components of this product.

Dosage and administration

Usual adult dose is 1 to 2 tablets daily, or as directed by a physician.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Rx Only Dietary Supplement

DESCRIPTION:

STATEMENT OF IDENTITY SECTION

This product 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 tan colored caplet-shaped tablet is debossed with “203” on one side and plain on the other.

INGREDIENTS:

HEALTH CLAIM SECTION

Each tablet of NicaprinTM contains:

 Niacin (nicotinamide) 250 mg
 Folic Acid 500 mcg
 Vitamin B6 (pyridoxine HCl) 4.5 mg
 Copper (cupric oxide) 1.4 mg
 Zinc (zinc oxide) 9 mg
 Soliprin (scutellaria baicalensis (root) & acacia catechu (heartwood)) 125 mg

OTHER INGREDIENTS:

HEALTH CLAIM SECTION

Iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, starch, silica, talc, and titanium dioxide.

INDICATIONS AND USAGE:

HEALTH CLAIM SECTION

This product is indicated for patients who are deficient in, or at risk of deficiency in, one or more of the components of this product.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

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

WARNINGS AND PRECAUTIONS:

WARNINGS SECTION

This product should be administered with caution in patients with a history of liver disease, jaundice or diabetes mellitus. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs and/or supplements should be considered. Folic acid above 1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive. Abnormal liver functions tests have been reported in persons taking daily doses of 500 mg or more of niacinamide.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PREGNANCY & NURSING MOTHERS:

HEALTH CLAIM SECTION

This product is not indicated for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. Physicians and medical practitioners should administer this product with caution to patients who are pregnant, lactating and/or taking medication.

ADVERSE REACTIONS:

HEALTH CLAIM SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1 to 2 tablets daily, or as directed by a physician.

HOW SUPPLIED:

HEALTH CLAIM SECTION

This product is supplied in the following size(s):
60 count bottles, NDC 57893-203-60

HEALTH CLAIM SECTION

Store between 15°C and 30°C (between 59°F and 86°F). Tamper evident by foil seal under cap.

HEALTH CLAIM SECTION

Manufactured for:
Artesa Labs, LLC
137585 Research Blvd.
Suite 125
Austin, TX 78750
v1 Rev. 05/16 826146

PRINCIPAL DISPLAY PANEL - 60 TABLET BOTTLE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57893-203-60

Rx Only

NICAPRINTM

Dietary Supplement

60 Tablets

Artesa Labs

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57893-203-60NICAPRIN60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57893-203NICAPRIN (NICOTINAMIDE, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CUPRIC OXIDE, ZINC OXIDE, AND SOLIPRIN) TABLET [ARTESA LABS, LLC]11 package rows20160927_52cc4bd5-427f-4a5e-8da0-a4cca3258899.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57893-203-60EA - Each57893-2036332b530-a6c8-4f3b-90d8-036a5ed066c112016-11-08

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
57893-20357893-203-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACIN2679MF687AACTIB
FOLIC ACID935E97BOY8ACTIB
CUPRIC OXIDEV1XJQ704R4ACTIM
ZINC OXIDESOI2LOH54ZACTIM
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SODIUM BICARBONATE8MDF5V39QOIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
SCUTELLARIA BARBATA WHOLEDPR4R122E7IACT
ACACIA CATECHU WOODCHL342Y4LAIACT

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NiacinNIACINGolden State Medical Supply, Inc.8eff9205-84ac-e69d-e053-2995a90aad4b2026-04-15Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAvPAKdd60fe81-3d54-4a29-9502-601be89c575e2026-02-25Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINQUAGEN PHARMACEUTICALS LLC249e27ac-e1e7-42dc-84f6-cd32fd1d9dee2025-12-25Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINRedmont Pharmaceuticals, LLCf51f7e6d-b132-48d8-8bb1-54203472f0d82025-12-17Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINChartwell RX, LLC568c3a99-b6e8-48b4-bb68-867bbcefa0272025-12-08Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINLannett Company, Inc.d7b66e13-00ed-48a9-a54a-8e474cc31d542025-11-10Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAmneal Pharmaceuticals LLC7250313b-b2ef-4736-bd25-2f29c2ac0eb92025-10-03Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINMacleods Pharmaceuticals Limited52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e2025-01-10Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINSun Pharmaceutical Industries, Inc.8e290f96-e8c6-47fd-863f-1c9480f28d9b2023-11-24Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINLupin Pharmaceuticals, Inc.92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b92023-10-06Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAurobindo Pharma Limited43233a21-3f90-4c69-bbeb-f50d5f2d35ae2023-02-14Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacorNIACINAvondale Pharmaceuticals, LLCbf287412-160b-403f-8eb4-57f29a4759022021-12-23Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINEmerald Therapeutics, LLC5fceeb58-e54d-43c1-8abb-33feea69d6632021-04-07Warnings, Adverse reactionsName fallback
generic name: NIACIN

Reported adverse events (FAERS/openFDA)#

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