FDA.reportPublic FDA data

Hydrate

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-09-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:22:12

Label at a glance#

ProductHydrate II
Active ingredientCOFFEA ARABICA SEED, ROASTED, AVENA SATIVA FLOWERING TOP, EQUISETUM HYEMALE WHOLE, HYPERICUM PERFORATUM WHOLE, GINKGO, GERMANIUM SESQUIOXIDE, SILICON DIOXIDE
Label structure9 sections

Dosage and administration

Mix 3 parts water to one part juice, add 6 drops Hydrate II to 8 oz mixture or add 30 drops to a quart mixture. Drink 4 eight oz glasses daily in between meals. Drink Hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less Hydrate/water mixture. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Coffea Tosta 1X, Avena Sativa 3X, Equisetum Hyemale 3X, Hypericum Perforatum 3X, Ginkgo Biloba 6X, Germanium Sesquioxide 8X, Silicea 8X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Mix 3 parts water to one part juice, add 6 drops Hydrate II to 8 oz mixture or add 30 drops to a quart mixture. Drink 4 eight oz glasses daily in between meals. Drink Hydrate/water mixture for 6 days and then only water for one day. Repeat. After eight weeks begin drinking more pure water and less Hydrate/water mixture. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Celandine (Leaf, Stem, Flower) Chelidonium Majus, Beet (Root) Beta Vulgaris, Blessed Thistle (Leaf, Stem, Flower) Cnicus Benedictus, Boldo (Leaf) Peumus Boldus, Dandelion (Root) Taraxacum Officinale, Parsley (Leaf) Petroselinum Crispum, Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

HYDRATE II

HOMEOPATHIC

2 FL OZ  (60 ml)

Hydrate IIHydrate II

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35E1
EQUISETUM HYEMALEACTIVE INGREDIENT59677RXH251
GERMANIUM SESQUIOXIDEACTIVE INGREDIENT96WE91N25T1
GINKGOACTIVE INGREDIENT19FUJ2C58T1
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35E1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
EQUISETUM HYEMALEACTIVE MOIETY59677RXH251
GERMANIUM SESQUIOXIDEACTIVE MOIETY96WE91N25T1
GINKGOACTIVE MOIETY19FUJ2C58T1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BEETINACTIVE INGREDIENTN487KM8COK1
CENTAUREA BENEDICTAINACTIVE INGREDIENT6L5ZL097951
CHELIDONIUM MAJUSINACTIVE INGREDIENT7E889U5RNN1
PARSLEYINACTIVE INGREDIENT58FMD0Q0EV1
PEUMUS BOLDUS LEAFINACTIVE INGREDIENTQ4EWM09M3O1
TARAXACUM OFFICINALE ROOTINACTIVE INGREDIENT9DE5YCO0RU1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-008043857-0080-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
COFFEA ARABICA SEED, ROASTED9H58JRT35EACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
EQUISETUM HYEMALE WHOLE59677RXH25ACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
GINKGO19FUJ2C58TACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNIACT
BEETN487KM8COKIACT
CENTAUREA BENEDICTA6L5ZL09795IACT
PEUMUS BOLDUS LEAFQ4EWM09M3OIACT
TARAXACUM OFFICINALE ROOT9DE5YCO0RUIACT
PARSLEY58FMD0Q0EVIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 (package): 43857-0080-1
ndc (product): 43857-0080
ndc11 (package): 43857008001
spl id: 7bf668c6-531a-4c35-adfd-89295fe1e85c
spl set id: 2d3657d9-d4f4-426c-b381-dbfde9b8e2cd

Reported adverse events (FAERS/openFDA)#

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