FDA.reportPublic FDA data

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
AVENA SATIVA FLOWERING TOP3 [hp_X]/mL
COFFEA ARABICA SEED, ROASTED1 [hp_X]/mL
EQUISETUM HYEMALE WHOLE3 [hp_X]/mL
GERMANIUM SESQUIOXIDE8 [hp_X]/mL
GINKGO6 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE3 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMA9CQJ3F7F, 9H58JRT35E, 59677RXH25, 96WE91N25T, 19FUJ2C58T, XK4IUX8MNB, ETJ7Z6XBU4

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

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