NDC 43857-0655-01 — Renotox Triticum Aestivum, Asparagus

🆔 Identity & classification

FDA NDC (as labeled) 43857-0655-1

Product NDC 43857-0655

11-digit billing NDC 43857065501

UNII 3C3Y389JBU, Z1EJP3037Z, 1TH8Q20J0U, VB06AV5US8, 660YQ98I10, 1WZA4Y92EX +12 more

SPL Set ID 2b691b17-296b-49d2-924e-c62522d4b9a7

Established class (EPC) Non-Standardized Food Allergenic Extract; Standardized Chemical Allergen; Copper-containing Intrauterine Device; Acetylcholine Release Inhibitor; Neuromuscular Blocker

Mechanism of action Acetylcholine Release Inhibitors

Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization; Neuromuscular Blockade

Chemical class Allergens; Dietary Proteins; Vegetable Proteins; Copper

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-03-20

Route ORAL

Dosage form LIQUID

Substance TRITICUM AESTIVUM WHOLE; ASPARAGUS; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA WHOLE; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM WHOLE; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; AGATHOSMA BE

Why two NDCs? The FDA registers this code as 43857-0655-1 — 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 → 43857-0655-01. 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

LabelerBioActive Nutritional, Inc.

Labeler code43857

First marketedMar 2025

Product typeHuman Otc Drug

Portfolio315 products on file

🔎 All NDCs from BioActive Nutritional, Inc.

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?

Renotox is an unapproved homeopathic liquid product taken by mouth that contains botanical extracts, mineral substances, and other ingredients traditionally used in homeopathic practice. The formulation includes plant materials such as uva-ursi, asparagus, berberis, and solidago, along with various mineral and chemical substances in highly diluted homeopathic potencies. Homeopathic products are marketed based on homeopathic tradition rather than evaluated by the FDA for safety or effectiveness. This product listing reflects ingredients as they appear in homeopathic preparations and should not be understood as representing established medical uses.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 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.

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

The official label also statesDemineralized 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.

💲 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
Renotox 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL 43857-0582-01	BioActive	60 ml	—	—	FDA listed	—
Renotox 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mLthis 43857-0655-01	BioActive	60 ml	—	—	FDA listed	—
Renotox 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL 43857-0634-01	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

🏛️

2025

On the market since

Mar 2025

📍

2026

Currently FDA-listed

1 year 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
43857-0655-01 You're viewing this	60 mL in 1 BOTTLE, DROPPER (43857-0655-1)	2025-03-20	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Renotox Triticum Aestivum, Asparagus Officinalis, Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Barosma (Betulina), Eupatorium Purpureum, Kidney (Suis), Bry 1 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [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 FDA registers it as 43857-0655-1, 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: 43857-0655-01, written without dashes as 43857065501. 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 43857-0655-01, the first segment (43857) is the labeler code FDA assigned to BioActive Nutritional, Inc.; the middle segment (0655) 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 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.

📄 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 25 words ▾

INDICATIONS: For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

⏱️ Dosage and Administration 20 words ▾

DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

⚠️ Warnings 50 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 a cool, dry place.

🧪 Active Ingredient ~1 min read ▾

ACTIVE INGREDIENTS: Triticum Aestivum MT, Asparagus Officinalis 3X, Berberis Vulgaris 3X, Echinacea 3X, Kali Muriaticum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Solidago Virgaurea 3X, Taraxacum Officinale 3X, Uva-Ursi 3X, Barosma 5X, Eupatorium Purpureum 6X, Kidney 8X, Bryonia 12X, Mercurius Corrosivus 12X, Aluminum Metallicum 12X, 30X, Antimonium Crudum 12X, 30X, Argentum Metallicum 12X, 30X, Arsenicum Album 12X, 30X, Aurum Metallicum 12X, 30X, Baryta Carbonica 12X, 30X, Beryllium Metallicum 12X, 30X, Bismuthum Metallicum 12X, 30X, Boron 12X, 30X, Bromium 12X, 30X, Cadmium Metallicum 12X, 30X, Cerium Metallicum 12X, 30X, Cesium Chloride 12X, 30X, Chromium 12X, 30X, Cobaltum Metallicum 12X, 30X, Cuprum Metallicum 12X, 30X, Dysprosium Metallicum 12X, 30X, Erbium Metallicum 12X, 30X, Europium Metallicum 12X, 30X, Ferrum Metallicum 12X, 30X, Gadolinium Metallicum 12X, 30X, Germanium Sesquioxide 12X, 30X, Holmium Metallicum 12X, 30X, Indium Metallicum 12X, 30X, Lithium Carbonicum 12X, 30X, Magnesium Metallicum 12X, 30X, Manganum Metallicum 12X, 30X, Mercurius Solubilis 12X, 30X, Molybdenum 12X, 30X, Neodymium Oxide 12X, 30X, Niccolum Metallicum 12X, 30X, Osmium Metallicum 12X, 30X, Palladium Metallicum 12X, 30X, Platinum Metallicum 12X, 30X, Plumbum Metallicum 12X, 30X, Praseodymium Metallicum 12X, 30X, Rhodium Metallicum 12X, 30X, Rubidium Nitricum 12X, 30X, Samarium Metallicum 12X, 30X, Selenium Metallicum 12X, 30X, Stannum Metallicum 12X, 30X, Strontium Carbonicum 12X, 30X, Terbium Metallicum 12X, 30X, Thallium Metallicum 12X, 30X, Uranium Nitricum 12X, 30X, Vanadium Metallicum 12X, 30X, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Influenzinum 30C, Morbillinum 30X, Botulinum 30X, 60X, Colibacillinum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, Lanthanum Metallicum 14C, Clostridium Perfringens 19C, 30C, Epstein-Barr Virus Nosode 30C, Niobium Metallicum 30C, Poliomyelitis Nosode 30C, Tantalum Metallicum 30C.

🧪 Inactive Ingredients 6 words ▾

INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol

🎯 Purpose 25 words ▾

PURPOSE: For temporary relief of pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.

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

🔗 Related NDC lookups

🧪 All Triticum Aestivum, Asparagus Officinalis, Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Barosma (Betulina), Eupatorium Purpureum, Kidney (Suis), Bry NDCsSame ingredient 🏭 All BioActive labeler NDCsLabeler code 43857 📚 All Acetylcholine Release Inhibitor NDCsDrug class