DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:38:26

Label at a glance#

ProductHydrate I
Active ingredientCOFFEA ARABICA SEED, ROASTED, GINKGO, GERMANIUM SESQUIOXIDE, SILICON DIOXIDE
Label structure9 sections

Indications and uses

For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headache, and low back pain.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Coffea Tosta MT, Germanium Sesquioxide 8X, Ginkgo Biloba 6X, Silica 8X.

PURPOSE:

OTC - PURPOSE SECTION

Coffea Tosta - headache,** Germanium Sesquioxide – low fatigue,** Ginkgo Biloba – brain fatigue,** Silica – headache**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

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

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional 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.

QUESTIONS:

OTC - QUESTIONS SECTION

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

HYDRATE I

HOMEOPATHIC

2 fl. oz. (60mL)

HYDRATE IHYDRATE I

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341640GTIN-13: 0210184341640
EAN-13: 0210184341640
GTIN-12: 210184341640
UPC-A: 210184341640
GTIN storage (14 digits): 00210184341640
BANI0179 Hydrate I 2-11-26.jpg

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
IngredientTypeUNIISPL versionUploaded
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35E1
GERMANIUM SESQUIOXIDEACTIVE INGREDIENT96WE91N25T1
GINKGOACTIVE INGREDIENT19FUJ2C58T1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35E1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
GERMANIUM SESQUIOXIDEACTIVE MOIETY96WE91N25T1
GINKGOACTIVE MOIETY19FUJ2C58T1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BEETINACTIVE INGREDIENTN487KM8COK1
CENTAUREA BENEDICTA FLOWERING TOPINACTIVE INGREDIENTNJN80GZ34N1
CHELIDONIUM MAJUSINACTIVE INGREDIENT7E889U5RNN1
PETROSELINUM CRISPUMINACTIVE INGREDIENT1WZA4Y92EX1
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 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-019843857-0198-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
ndc (package): 43857-0198-1
ndc (product): 43857-0198
ndc11 (package): 43857019801
spl id: f75a0424-48db-41e5-aa5d-10cfa74269a7
spl set id: c0c8d350-0257-4484-acd8-f852350173db

Reported adverse events (FAERS/openFDA)#

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