FDA.reportPublic FDA data

Ginkgo Tonic

Product NDC
43857-0383
Requested package NDC
43857-0383-1
11-digit product format
438570383
Labeler code
43857
Product ID
43857-0383_2290ed30-0d34-4259-a7b0-0ee1a97a691a
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-11-30
Substance
ADENOSINE TRIPHOSPHATE DISODIUM; AMERICAN GINSENG; ARONIA MELANOCARPA FRUIT; BARIUM CHLORIDE DIHYDRATE; BILBERRY; CENTELLA ASIATICA WHOLE; CLAVICEPS PURPUREA SCLEROTIUM; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; LEAD; POTASSIUM PHOSPHATE, DIBASIC; TOBACCO LEAF; UBIDECARENONE; VISCUM ALBUM FRUITING TOP
Active strength
30; 1; 3; 12; 3; 1; 12; 1; 8; 1; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Ginkgo Tonic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMERICAN GINSENG30 [hp_X]/mL
GINKGO1 [hp_X]/mL
CENTELLA ASIATICA WHOLE3 [hp_X]/mL
FALLOPIA MULTIFLORA ROOT12 [hp_X]/mL
ARONIA MELANOCARPA FRUIT3 [hp_X]/mL
BILBERRY1 [hp_X]/mL
GERMANIUM SESQUIOXIDE12 [hp_X]/mL
GOLD1 [hp_X]/mL
BARIUM CHLORIDE DIHYDRATE8 [hp_X]/mL
POTASSIUM PHOSPHATE, DIBASIC1 [hp_X]/mL
LEAD12 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM12 [hp_X]/mL
TOBACCO LEAF12 [hp_X]/mL
VISCUM ALBUM FRUITING TOP12 [hp_X]/mL
UBIDECARENONE12 [hp_X]/mL
ADENOSINE TRIPHOSPHATE DISODIUM12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W75VCV53QInternal UNII lookup
19FUJ2C58TInternal UNII lookup
7M867G6T1UInternal UNII lookup
AUZ3VD75MCInternal UNII lookup
S935718Z2QInternal UNII lookup
9P2U39H18WInternal UNII lookup
96WE91N25TInternal UNII lookup
79Y1949PYOInternal UNII lookup
EL5GJ3U77EInternal UNII lookup
CI71S98N1ZInternal UNII lookup
2P299V784PInternal UNII lookup
01G9XEA93NInternal UNII lookup
6YR2608RSUInternal UNII lookup
BK9092J5MPInternal UNII lookup
EJ27X76M46Internal UNII lookup
5L51B4DR1GInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f26ecaab-d3fc-47de-a0ef-b0a3f0f4f71fAvailable on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-10-17DRUG FACTS:
2023-01-30DRUG FACTS:
2021-05-18DRUG FACTS:
2020-01-31DRUG 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0383-14385703830160 mL in 1 BOTTLE, DROPPER (43857-0383-1) 60 ml2015-11-300000-00-00NoNoCurrent