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Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mL Liquid, 60 mL — NDC 43857-0080-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mL Liquid, 60 mL — NDC 43857-0080-1 (Billing 43857-0080-01)

by BioActive Nutritional, Inc. · 60 mL in 1 BOTTLE, DROPPER

This is a package of 60 mL of Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mL Liquid from BioActive Nutritional, Inc., marketed since Feb 2013 and currently FDA-listed. It is this product's only package size.

NDC 43857-0080-01
🏷️ FDA NDC (as labeled) 43857-0080-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 43857-0080-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
43857 labeler · 0080 product · 1 package
Package marketed since
Aug 16, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4385700801 1
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43857-0080-1
Product NDC 43857-0080
11-digit billing NDC 43857008001
UNII 9H58JRT35E, MA9CQJ3F7F, 59677RXH25, XK4IUX8MNB, 19FUJ2C58T, 96WE91N25T +1 more
SPL Set ID 2d3657d9-d4f4-426c-b381-dbfde9b8e2cd
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-02-18
Route ORAL
Dosage form LIQUID
Substance COFFEA ARABICA SEED, ROASTED; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE WHOLE; HYPERICUM PERFORATUM WHOLE; GINKGO; GERMANIUM SESQUIOXIDE; SILICON DIOXIDE
Why two NDCs? The FDA registers this code as 43857-0080-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 43857-0080-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Hydrate II is an unapproved homeopathic liquid taken by mouth. It contains roasted coffee seed, oat flowering top, horsetail, St. John's wort, ginkgo, germanium sesquioxide, and silicon dioxide in homeopathic dilutions. In homeopathic practice, these plant and mineral substances are traditionally used to support hydration and general wellness, though homeopathic products are not evaluated by the FDA for effectiveness and are marketed based on homeopathic tradition rather than clinical evidence.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43857-0080-01 You're viewing this Main listing 60 mL in 1 BOTTLE, DROPPER 2016-08-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrate II 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mLthis 43857-0080-01 BioActive 60 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII N487KM8COK
    A natural red colorant derived from beets. It's used to give medicines their color and help patients identify the correct dosage form.
  • UNII 6L5ZL09795
    A plant-derived ingredient from blessed thistle used as a flavoring agent or natural additive in medicines to add taste or aroma to the product.
  • UNII 7E889U5RNN
    A plant material derived from greater celandine, used as a natural extract or botanical ingredient. It may function as a colorant, flavoring agent, or contribute to the overall formulation's botanical composition.
  • UNII 58FMD0Q0EV
    A plant extract used as a natural flavoring and coloring agent in medicines. It adds taste appeal and may provide a mild green tint to the final product.
  • UNII Q4EWM09M3O
    A plant extract from the boldo tree, native to South America. It's used in some formulations as a flavoring agent or natural ingredient to add taste or aroma to the medicine.
  • UNII 9DE5YCO0RU
    A plant extract from dandelion root traditionally used in herbal preparations. In medications, it may serve as a flavor enhancer, natural colorant, or bitter component that supports formulation taste and appearance.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCelandine (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.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBioActive Nutritional, Inc.
Labeler code43857
First marketedFeb 2013
Product typeHuman Otc Drug
Portfolio315 products on file

More NDCs from BioActive Nutritional, Inc. labeler code 43857

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

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

⏱️ Dosage and Administration 73 words ▾

DIRECTIONS: 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.

⚠️ Warnings 49 words ▾

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 cool, dry place.

🧪 Active Ingredient 22 words ▾

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

🧪 Inactive Ingredients 35 words ▾

INACTIVE INGREDIENTS: 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.

🎯 Purpose 21 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 14 words ▾

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

📄 Package Label / Principal Display Panel 16 words ▾

PACKAGE LABEL DISPLAY: BIO Active Nutritional HYDRATE II HOMEOPATHIC 2 FL OZ (60 ml) Hydrate II

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mL LIQUID is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BioActive Nutritional, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BioActive Nutritional, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43857-0075-01 · BioActive 43857-0084-01 · BioActive →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.