NDC 83027-0133-01 — Mycotox Glandula Suprarenalis (Bovine)

🆔 Identity & classification

FDA NDC (as labeled) 83027-0133-1

Product NDC 83027-0133

11-digit billing NDC 83027013301

UNII M2776SWB29, 190Q9MB3U3, 6GLA1946WX, 1NT28V9397, FOF26T73HA, MN18OTN73W +12 more

UPC 0649818024282

SPL Set ID f19eca09-6733-41e7-b0a9-94d5a3d8a728

Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Fungal Allergenic Extract

Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production

Chemical class Allergens; Dietary Proteins; Fungal Proteins

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-09-25

Route ORAL

Dosage form SPRAY

Substance BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; HANDROANTHUS IMPETIGINOSUS BARK; THUJA OCCIDENTALIS LEAFY TWIG; LAMB; THYROID, BOVINE; SODIUM BORATE; COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; SUS SCROFA LYMPH; ARSENIC TRIOXIDE; ZINC; ASPERGILLUS NIGER VAR.

Why two NDCs? The FDA registers this code as 83027-0133-1 — 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 → 83027-0133-01. 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

LabelerNutritional Specialties, Inc.

Labeler code83027

First marketedSep 2024

Product typeHuman Otc Drug

Portfolio162 products on file

🔎 All NDCs from Nutritional Specialties, 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?

This is an unapproved homeopathic oral spray containing multiple ingredients used in homeopathic tradition, including fungal and candida extracts, bovine organ tissues, and plant materials. Homeopathic products are marketed based on traditional homeopathic practice and are not evaluated by the FDA for effectiveness or safety. The ingredients in this product are typically selected in homeopathic formulations for their purported role in supporting immune or lymphatic function, though these uses are not established through standard medical evidence. Homeopathic products are diluted according to homeopathic principles and contain extremely small or no measurable amounts of their original substances.

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 statesAlcohol USP 20%, Purified Water USP.

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
Mycotox 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mLthis 83027-0133-01	Nutritional	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

🏛️

2024

On the market since

Sep 2024

📍

2026

Currently FDA-listed

2 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
83027-0133-01 You're viewing this	60 mL in 1 BOTTLE, SPRAY (83027-0133-1)	2024-09-25	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Mycotox Glandula Suprarenalis (Bovine), Spleen (Bovine), Tabebuia Impetiginosa (Pau D Arco), Thuja Occidentalis, Thymus (Ovine), Thyroidinum (Bovine), Borax, Colchicum Autumnale, Lacticum Acidum, Lymph Node (Suis), Arsenicum Album, Zincum Metallicum, Aspergillus 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL SPRAY 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 83027-0133-1, 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: 83027-0133-01, written without dashes as 83027013301. 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 83027-0133-01, the first segment (83027) is the labeler code FDA assigned to Nutritional Specialties, Inc.; the middle segment (0133) 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 Nutritional Specialties, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Nutritional Specialties, 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 33 words ▾

USES: Aids in temporary relief of achiness, fatigue, fever, headache, itchy eyes, red or itchy skin, rhinitis, and runny nose.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 45 words ▾

DIRECTIONS: • Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. • Do not take within 15 minutes of consuming food, beverage or brushing teeth. • Consult a physician for use in children under 12 years of age.

⚠️ Warnings 56 words ▾

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. If condition worsens, seek medical attention. KEEP OUT OF REACH OF CHILDREN Do not use if tamper evident seal is broken or missing. Store in a cool place after opening

🧪 Active Ingredient 69 words ▾

ACTIVE INGREDIENTS: Alternaria Tenuis Nees 60X, Arsenicum Album 12X, Aspergillus Niger 16X, Borax 6X, 12X, Candida Albicans 16X, Candida Krusei 16C, Candida Parapsilosis 16X, Candida Tropicalis 32C, Colchicum Autumnale 6X, 12X, 30X, Glandula Suprarenalis 6X, Lacticum Acidum 6X, 12X, 30X, Lymph Node 8X, Mucor Racemosus 16X, Rhizopus Nigricans 16C, Spleen 6X, Tabebuia Impetiginosa (Pau D’Arco) 6X, Thuja Occidentalis 6X, Thymus 6X, Thyroidinum 6X, Torula Cerevisiae 16X, Zincum Metallicum 12X.

🧪 Inactive Ingredients 8 words ▾

INACTIVE INGREDIENTS: Alcohol USP 20%, Purified Water USP.

🎯 Purpose ~1 min read ▾

PURPOSE: Alternaria Tenuis Nees – Assists in Relief of Headache, Itchy Eyes, and Runny Nose,† Arsenicum Album – Assists in Relief of Headache, Fatigue, and Fever,† Aspergillus Niger – Assists in Relief of Achiness, Fever, Headache, and Itchy Eyes,† Borax – Assists in Relief of Fatigue, Headache, and Itchy Skin,† Candida Albicans – Assists in Relief of Red or Itchy Skin,† Candida Krusei – Assists in Relief of Fatigue, and Red or Itchy Skin,† Candida Parapsilosis – Assists in Relief of Fatigue, Headache, Rhinitis, and Red or Itchy Skin,† Candida Tropicalis – Assists in Relief of Red or Itchy Skin,† Colchicum Autumnale – Assists in Relief of Fever, and Headache,† Glandula Suprarenalis – Support of Adrenal and Assists in Relief of Fatigue,† Lacticum Acidum – Assists in Relief of Fatigue,† Lymph Node – Lymphatic System Drainage and Support, and Assists in Relief of Fatigue,† Mucor Racemosus – Assists in Relief of Headache, Itchy Eyes, Itchy Skin, Rhinitis, and Runny Nose,† Rhizopus Nigricans – Assists in Relief of Itchy Eyes, Red or Itchy Skin, and Runny Nose,† Spleen – Support of Spleen,† Tabebuia Impetiginosa (Pau D’Arco) – Antioxidant, and Assists in Relief of Fever,† Thuja Occidentalis – Assists in Relief of Fatigue, Fever, Headache, and Rhinitis,† Thymus – Support of Thymus,† Thyroidinum – Support of Thyroid, and Assists in Relief of Fatigue,† Torula Cerevisiae – Assists in Relief of Achiness, Fatigue, Headache, and Itchy Skin,† Zincum Metallicum – Assists in Relief of Fatigue, Headache, and Rhinitis† †Claims based on traditional homeopathic practice, not accepted medical evidence.

Not FDA evaluated.

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

🔗 Related NDC lookups

🧪 All Glandula Suprarenalis (Bovine), Spleen (Bovine), Tabebuia Impetiginosa (Pau D Arco), Thuja Occidentalis, Thymus (Ovine), Thyroidinum (Bovine), Borax, Colchicum Autumnale, Lacticum Acidum, Lymph Node (Suis), Arsenicum Album, Zincum Metallicum, Aspergillus NDCsSame ingredient 🏭 All Nutritional labeler NDCsLabeler code 83027