FDA.reportPublic FDA data

Vigen Dr. Nattokinase

Manufacturer
Vigen medical | Pohangbiopark
Effective date
2021-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:40

Label at a glance#

ProductVigen Dr. Nattokinase
Active ingredientNATTOKINASE, LAGERSTROEMIA SPECIOSA LEAF
Label structure11 sections

Indications and uses

■ Natto Bacillus Culture powder It can help to improve blood circulation. ■ Banaba Leaf Extract It can help to suppress blood sugar levels after meals.

Dosage and administration

■ Take 1 capsule once a day with sufficient water.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

NATTO BACILLUS CULTURE POWDER 13.4%
BANABA LEAF EXTRACT 9%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Bees Wax, Fermeted Soybean Extract, Fermented Soybean Extract, Lecithin, Garlic Extract Powder, Broccoli Sprout Powder, Gingko Biloba Extract Powder, Dried Yeast, Thiamine Mononitrate, Pyridoxine Hydrochloride, Folic acid

PURPOSE

OTC - PURPOSE SECTION

Improve blood circulation
Suppress blood sugar

WARNINGS

WARNINGS SECTION

■ Be sure to drink it with water as it may get stuck in your throat or uncomfortable.
■ If you have symptoms of gastrointestinal disorders or indigestion when ingesting, stop ingesting.
■ If you experience abnormal symptoms depending on your individual's physical condition, stop ingesting.
■ Do not consume if there is anything wrong with product before ingestion. Children, pregnant women and lactating women should be careful about their intake.
■ Be careful of your intake before and after surgery. Be careful when taking medicine (blood anticoagulants).
■ Please be careful because you should not take the "dehumidifier" packaged separately for food quality control.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ Natto Bacillus Culture powder
It can help to improve blood circulation.
■ Banaba Leaf Extract
It can help to suppress blood sugar levels after meals.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Take 1 capsule once a day with sufficient water.

Other Information

OTHER SAFETY INFORMATION

■ Store in a cool place to avoid direct sunlight as quality may be affected by moisture and heat.
■ Keep it out of reach of children.

Questions

OTC - QUESTIONS SECTION

■ Customer call
+82-1644-7582

PACKAGE LABEL82437-030-02 : 30 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

PACKAGE LABEL82437-030-03 : 60 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809292030236GTIN-13: 8809292030236
EAN-13: 8809292030236
GTIN storage (14 digits): 08809292030236		30 carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82437-030-022024-01-30C16284748780-11030e365-5237-111a-e063-dadaa90a10e2dbb6f852-b473-4b04-a149-d436faafe7d6
82437-030-032024-01-30C16284748780-11030e365-5237-111a-e063-dadaa90a10e2dbb6f852-b473-4b04-a149-d436faafe7d6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82437-030-01Vigen Dr. Nattokinase500 mg in 1 BLISTER PACKTABLET5001
82437-030-02Vigen Dr. Nattokinase30 in 1 CARTONTABLET301
82437-030-03Vigen Dr. Nattokinase60 in 1 CARTONTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82437-030VIGEN DR. NATTOKINASE (NATTO BACILLUS, BANABA LEAF) TABLET [VIGEN MEDICAL]1Legacy NDC, 3 package rows20211215_dbb6f852-b473-4b04-a149-d436faafe7d6.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82437-03082437-030-01, 82437-030-02, 82437-030-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
NATTOKINASEH81695M5OPACTIB
LAGERSTROEMIA SPECIOSA LEAFOUK5B3W9E4ACTIB
YELLOW WAX2ZA36H0S2VIACT
SOYBEAN OIL241ATL177AIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
317cb883-fa0a-462c-a135-aa60b66b4c24dbb6f852-b473-4b04-a149-d436faafe7d62021-12-15WarningsExact identifier
spl id: 317cb883-fa0a-462c-a135-aa60b66b4c24
spl set id: dbb6f852-b473-4b04-a149-d436faafe7d6

Reported adverse events (FAERS/openFDA)#

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