Hydrate

Product NDC
43857-0080
11-digit product format
438570080
Labeler code
43857
Product ID
43857-0080_7bf668c6-531a-4c35-adfd-89295fe1e85c
Type
HUMAN OTC DRUG
Nonproprietary name
Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-02-18
Substance
AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; EQUISETUM HYEMALE WHOLE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM WHOLE; SILICON DIOXIDE
Active strength
3; 1; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrate
Brand name suffix
II
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COFFEA ARABICA SEED, ROASTED3 [hp_X]/mL
AVENA SATIVA FLOWERING TOP1 [hp_X]/mL
EQUISETUM HYEMALE WHOLE3 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE8 [hp_X]/mL
GINKGO6 [hp_X]/mL
GERMANIUM SESQUIOXIDE3 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9H58JRT35EInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
59677RXH25Internal UNII lookup
XK4IUX8MNBInternal 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
2d3657d9-d4f4-426c-b381-dbfde9b8e2cdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0080-12023-09-01C16284748780-1f386c64a-1236-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0080-12023-01-30C16284748780-1f386c64a-1236-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0080-1HydrateII60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35EHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
EQUISETUM HYEMALEACTIVE INGREDIENT59677RXH25HYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GERMANIUM SESQUIOXIDEACTIVE INGREDIENT96WE91N25THYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GINKGOACTIVE INGREDIENT19FUJ2C58THYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNBHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4HYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35EHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4HYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
EQUISETUM HYEMALEACTIVE MOIETY59677RXH25HYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GERMANIUM SESQUIOXIDEACTIVE MOIETY96WE91N25THYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GINKGOACTIVE MOIETY19FUJ2C58THYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNBHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
BEETINACTIVE INGREDIENTN487KM8COKHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
CENTAUREA BENEDICTAINACTIVE INGREDIENT6L5ZL09795HYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
CHELIDONIUM MAJUSINACTIVE INGREDIENT7E889U5RNNHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PARSLEYINACTIVE INGREDIENT58FMD0Q0EVHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PEUMUS BOLDUS LEAFINACTIVE INGREDIENTQ4EWM09M3OHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
TARAXACUM OFFICINALE ROOTINACTIVE INGREDIENT9DE5YCO0RUHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0080HYDRATE II (COFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20230902_2d3657d9-d4f4-426c-b381-dbfde9b8e2cd.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 IICOFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.2d3657d9-d4f4-426c-b381-dbfde9b8e2cd2023-09-01WarningsExact identifier
ndc (product): 43857-0080

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0080-14385700800160 mL in 1 BOTTLE, DROPPER (43857-0080-1) 60 ml2016-08-160000-00-00NoNoCurrent