![GB-Tone Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale 12 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 4 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 8 [hp_X]/mL; 9 [hp_X]/mL; 5 Liquid, 30 mL — NDC 64578-0130-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5620a1dc-b59c-4489-a548-20f3e488287f&name=ENTX0023+GB+Tone+7-9-18.jpg)
GB-Tone Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale 12 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 4 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 8 [hp_X]/mL; 9 [hp_X]/mL; 5 Liquid, 30 mL
by Energetix Corp · 30 mL in 1 BOTTLE, DROPPER (64578-0130-1)
NDC 64578-0130-01
🏷️ FDA NDC (as labeled)
64578-0130-1
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
64578-0130-1
Product NDC
64578-0130
11-digit billing NDC
64578013001
UNII
3UN285QN0C, 03J5ZE7KA5, Q4EWM09M3O, U946SH95EE, 7E889U5RNN, VB06AV5US8 +8 more
UPC
0364578030310
SPL Set ID
5620a1dc-b59c-4489-a548-20f3e488287f
Established class (EPC)
Anticholinergic; Calculi Dissolution Agent; Cholinergic Muscarinic Antagonist; Inhibition Large Intestine Fluid/Electrolyt
Mechanism of action
Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
Physiologic effect
Increased Large Intestinal Motility
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2016-07-14
Route
ORAL
Dosage form
LIQUID
Substance
AMMI VISNAGA FRUIT; ATROPINE SULFATE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; BOS TAURUS BILE; PORK LIVER; GOLDENSEAL; VERONICASTRUM VIRGINICUM ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC,
Why two NDCs?
The FDA registers this code as 64578-0130-1 — 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 → 64578-0130-01. 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.
🏭 Manufacturer & labeler
LabelerEnergetix Corp
Labeler code64578
First marketedJul 2016
Product typeHuman Otc Drug
Portfolio4 products on file
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.
🩺 Clinical
🧪 What is this product?
GB-Tone is an unapproved homeopathic liquid taken by mouth that contains multiple plant and animal-derived ingredients. In homeopathic practice, these ingredients are traditionally used to support digestive and liver function, though homeopathic products are not evaluated by the FDA for effectiveness. The formula includes milk thistle, goldenseal, and chelidonium, which homeopathic practitioners associate with bile and liver support, along with other botanical extracts commonly found in traditional digestive tonics. This product is marketed based on homeopathic tradition rather than established clinical evidence.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
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.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesEthyl Alcohol, Glycerin, Purified Water
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.
💲 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 system | Per mL | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| GB-Tone 12 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 4 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 8 [hp_X]/mL; 9 [hp_X]/mL; 5this 64578-0130-01 | Energetix | 30 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
🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64578-0130-01 You're viewing this | 30 mL in 1 BOTTLE, DROPPER (64578-0130-1) | 2016-07-14 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
GB-Tone Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale 12 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 4 [hp_X]/mL; 12 [hp_X]/mL; 4 [hp_X]/mL; 8 [hp_X]/mL; 9 [hp_X]/mL; 5 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 FDA registers it as 64578-0130-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 64578-0130-01, written without dashes as 64578013001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 64578-0130-01, the first segment (64578) is the labeler code FDA assigned to Energetix Corp; the middle segment (0130) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Energetix Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Energetix Corp 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.
📄 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
🎯 Indications and Usage ▾
USES: Temporary relief of abdominal discomfort, indigestion, headaches.
⏱️ Dosage and Administration ▾
DIRECTIONS: Take 30 drops orally twice daily or as directed by a healthcare professional. Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
⚠️ Warnings ▾
WARNINGS: In case of overdose, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. Other information Store at room temperature out of direct sunlight. Do not use if neck wrap is broken or missing.
🧪 Active Ingredient ▾
ACTIVE INGREDIENTS: 59.1 mL contains 12.5% of Boldo 4X; Carduus Marianus 4X; Echinacea 4X; Hepar Suis 6C; Hydrastis Canadensis 5X; Natrum Phosphoricum 6X; Taraxacum Officinale 4X; 0.83% of: Ammi Visnaga 12X; Atropinum Sulphuricum 12X; Boldo 12X; Chelidonium Majus 12X; Fel Tauri 8X, 12X, 30X; Hepar Suis 9X, 12X, 30X; Leptandra Virginica 12X; Magnesia Phosphorica 12X, 30X; Natrum Phosphoricum 12X; Podophyllum Peltatum 12X.
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS: Ethyl Alcohol, Glycerin, Purified Water
🎯 Purpose ▾
PURPOSE: Temporary relief of abdominal discomfort, indigestion, headaches.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.