Hydrate I

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Hydrate I
Generic name: COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA
Manufacturer: BioActive Nutritional, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c0c8d350-0257-4484-acd8-f852350173db
SPL ID: f75a0424-48db-41e5-aa5d-10cfa74269a7
Version: 5
Effective date: 2026-04-30
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:28:14

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Hydrate I	openfda.brand_name
generic name		COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA	openfda.generic_name
manufacturer name		BioActive Nutritional, Inc.	openfda.manufacturer_name
ndc	package	43857-0198-1	openfda.package_ndc
ndc	product	43857-0198	openfda.product_ndc
ndc11	package	43857019801	derived:openfda.package_ndc
spl id		f75a0424-48db-41e5-aa5d-10cfa74269a7	id
spl set id		c0c8d350-0257-4484-acd8-f852350173db	set_id
unii		9H58JRT35E	openfda.unii
unii		96WE91N25T	openfda.unii
unii		ETJ7Z6XBU4	openfda.unii
unii		19FUJ2C58T	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: 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.

Reported adverse events (FAERS/openFDA)#

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