FDA.reportPublic FDA data

Ginkgo Tonic

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:16

Label at a glance#

ProductGinkgo Tonic
Active ingredientAMERICAN GINSENG, GINKGO, CENTELLA ASIATICA WHOLE, FALLOPIA MULTIFLORA ROOT, ARONIA MELANOCARPA FRUIT, BILBERRY, GERMANIUM SESQUIOXIDE, GOLD, BARIUM CHLORIDE DIHYDRATE, POTASSIUM PHOSPHATE, DIBASIC, LEAD, CLAVICEPS PURPUREA SCLEROTIUM, TOBACCO LEAF, VISCUM ALBUM FRUITING TOP, UBIDECARENONE, ADENOSINE TRIPHOSPHATE DISODIUM
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aralia Quinquefolia MT, Ginkgo Biloba MT, Hydrocotyle Asiatica MT, Polygonum Multiflorum MT, Aronia Melanocarpa 3X, Vaccinium Myrtillus 3X, Germanium Sesquioxide 8X, 12X, Aurum Metallicum 12X, Baryta Muriatica 12X, Kali Phosphoricum 12X, Plumbum Metallicum 12X, Secale Cornutum 12X, Tabacum 12X, Viscum Album 12X, Ubidecarenonum 12X, 30X, Adenosinum Triphosphoricum Dinatrum 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of coldness of the extremities; fingers and feet bluish and numb; shortness of breath on least exertion; fatigue; exhaustion and poor memory.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of coldness of the extremities; fingers and feet bluish and numb; shortness of breath on least exertion; fatigue; exhaustion and poor memory.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

GINKGO TONIC

2 FL OZ (60 ml)

Ginkgo TonicGinkgo Tonic

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0383-12024-10-17C16284748780-19d75b9d0-26b0-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0383-12023-01-30C16284748780-19d75b9d0-26b0-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0383-12021-05-18C16284748780-19d75b9d0-26b0-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0383-12020-01-31C16284748780-19d75b9d0-26b0-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0383-1Ginkgo Tonic60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0383GINKGO TONIC (ARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, POLYGONUM MULTIFLORUM, ARONIA MELANOCARPA, VACCINIUM MYRTILLUS, GERMANIUM SESQUIOXIDE, AURUM METALLICUM, BARYTA MURIATICA, KALI PHOSPHORICUM, PLUMBUM METALLICUM, SECALE CORNUTUM, TABACUM, VISCUM ALBUM, UBIDECARENONUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20241019_f26ecaab-d3fc-47de-a0ef-b0a3f0f4f71f.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-038343857-0383-1

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
AMERICAN GINSENG8W75VCV53QACTIB
GINKGO19FUJ2C58TACTIB
CENTELLA ASIATICA WHOLE7M867G6T1UACTIB
FALLOPIA MULTIFLORA ROOTAUZ3VD75MCACTIB
ARONIA MELANOCARPA FRUITS935718Z2QACTIB
BILBERRY9P2U39H18WACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
GOLD79Y1949PYOACTIB
BARIUM CHLORIDE DIHYDRATEEL5GJ3U77EACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
LEAD2P299V784PACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
TOBACCO LEAF6YR2608RSUACTIB
VISCUM ALBUM FRUITING TOPBK9092J5MPACTIB
UBIDECARENONEEJ27X76M46ACTIB
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Ginkgo TonicARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, POLYGONUM MULTIFLORUM, ARONIA MELANOCARPA, VACCINIUM MYRTILLUS, GERMANIUM SESQUIOXIDE, AURUM METALLICUM, BARYTA MURIATICA, KALI PHOSPHORICUM, PLUMBUM METALLICUM, SECALE CORNUTUM, TABACUM, VISCUM ALBUM, UBIDECARENONUM, ADENOSINUM TRIPHOSPHORICUM DINATRUMBioActive Nutritional, Inc.f26ecaab-d3fc-47de-a0ef-b0a3f0f4f71f2024-10-17WarningsExact identifier
ndc (package): 43857-0383-1
ndc (product): 43857-0383
ndc11 (package): 43857038301
spl id: 2290ed30-0d34-4259-a7b0-0ee1a97a691a
spl set id: f26ecaab-d3fc-47de-a0ef-b0a3f0f4f71f

Reported adverse events (FAERS/openFDA)#

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