Hydrate

Product NDC
43857-0198
11-digit product format
438570198
Labeler code
43857
Product ID
43857-0198_f75a0424-48db-41e5-aa5d-10cfa74269a7
Type
HUMAN OTC DRUG
Nonproprietary name
Coffea Tosta, Ginkgo Biloba, Germanium Sesquioxide, Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-09-11
Substance
COFFEA ARABICA SEED, ROASTED; GINKGO; GERMANIUM SESQUIOXIDE; SILICON DIOXIDE
Active strength
1; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43857-0198-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0198-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0198-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0198-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0198-11332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrate
Brand name suffix
I
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COFFEA ARABICA SEED, ROASTED1 [hp_X]/mL
GINKGO6 [hp_X]/mL
GERMANIUM SESQUIOXIDE8 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9H58JRT35EInternal UNII lookup
19FUJ2C58TInternal UNII lookup
96WE91N25TInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0c8d350-0257-4484-acd8-f852350173dbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0198-12024-10-17C16284748780-1f386c649-b9f8-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0198-12023-01-30C16284748780-1f386c649-b9f8-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0198-1HydrateI60 mL in 1 BOTTLE, DROPPERLIQUID605

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35EHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GERMANIUM SESQUIOXIDEACTIVE INGREDIENT96WE91N25THYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GINKGOACTIVE INGREDIENT19FUJ2C58THYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4HYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35EHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4HYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GERMANIUM SESQUIOXIDEACTIVE MOIETY96WE91N25THYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GINKGOACTIVE MOIETY19FUJ2C58THYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
BEETINACTIVE INGREDIENTN487KM8COKHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
CENTAUREA BENEDICTA FLOWERING TOPINACTIVE INGREDIENTNJN80GZ34NHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
CHELIDONIUM MAJUSINACTIVE INGREDIENT7E889U5RNNHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PETROSELINUM CRISPUMINACTIVE INGREDIENT1WZA4Y92EXHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PEUMUS BOLDUS LEAFINACTIVE INGREDIENTQ4EWM09M3OHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
TARAXACUM OFFICINALE ROOTINACTIVE INGREDIENT9DE5YCO0RUHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0198HYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20241019_c0c8d350-0257-4484-acd8-f852350173db.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
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
ndc (product): 43857-0198

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0198-14385701980160 mL in 1 BOTTLE, DROPPER (43857-0198-1) 60 ml2016-11-080000-00-00NoNoCurrent