NDC 63479-0214-01 — B14 BRONCHOTOX BELLADONNA, BLATTA ORIENTALIS

🆔 Identity & classification

FDA NDC (as labeled) 63479-0214-1

Product NDC 63479-0214

11-digit billing NDC 63479021401

UNII VB06AV5US8, 917J3173FT, 9PP1T3TC5U, CLF5YFS11O, U364V64HUN, 86H4S6K51N +12 more

SPL Set ID beeaca49-a683-7e57-e053-2995a90ac04f

Established class (EPC) Non-Standardized Food Allergenic Extract; Copper-containing Intrauterine Device; Non-Standardized Insect Allergenic Extract

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

Chemical class Allergens; Dietary Proteins; Milk Proteins; Copper; Insect Proteins

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1994-11-01

Route SUBLINGUAL

Dosage form SOLUTION/ DROPS

Substance ECHINACEA ANGUSTIFOLIA; COW MILK; LOBELIA INFLATA; PASSIFLORA INCARNATA FLOWERING TOP; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; THYMUS SERPYLLUM; VALERIAN; ATROPA BELLADONNA; SAMBUCUS NIGRA FLOWERING TOP; PROTORTONIA CACTI; HEDERA HELIX FLOWERING TWIG

Why two NDCs? The FDA registers this code as 63479-0214-1 — 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 → 63479-0214-01. 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

LabelerApex Energetics Inc.

Labeler code63479

First marketedNov 1994

Product typeHuman Otc Drug

Portfolio110 products on file

🔎 All NDCs from Apex Energetics 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?

B14 Bronchotox is a homeopathic solution taken under the tongue that contains multiple plant, mineral, and biological ingredients traditionally used in homeopathic practice. The formula includes substances such as belladonna, lobelia, ipecac, and goldenseal, which are historically associated with respiratory symptoms in homeopathic tradition, along with echinacea and other botanicals commonly included in homeopathic remedies. This is an unapproved homeopathic product marketed based on homeopathic principles rather than evaluated by the FDA for effectiveness or safety.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
B14 Bronchotox 1 [hp_X]/mL; 30 [hp_X]/mL; 3 [hp_X]/mL; 1 [hp_X]/mL; 30 [hp_X]/mL; 1 [hp_X]/mL; 1 [hp_X]/mLthis 63479-0214-01	Apex	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

🏛️

1994

On the market since

Nov 1994

📍

2026

Currently FDA-listed

32 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for B14 BRONCHOTOX (this brand).

Top reported reactions

Fatigue412

Diarrhoea321

Nausea300

Headache277

Dizziness253

Pain236

Arthralgia225

Reporter sex

Male · 28%

Female · 72%

Unknown · 0%

Serious outcomes

Death157

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
63479-0214-01 You're viewing this	30 mL in 1 BOTTLE, GLASS (63479-0214-1)	1994-11-01	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

B14 BRONCHOTOX BELLADONNA, BLATTA ORIENTALIS, COCCUS CACTI, CORALLIUM RUBRUM, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, HEDERA HELIX, HYDRASTIS CANADENSIS, IPECACUANHA, KALI NITRICUM, LAC VACCINUM, LOBELIA INFLATA, PASSIFLORA INCARNATA, PERTUSSINU 1 [hp_X]/mL; 30 [hp_X]/mL; 3 [hp_X]/mL; 1 [hp_X]/mL; 30 [hp_X]/mL; 1 [hp_X]/mL; 1 [hp_X]/mL SOLUTION/ DROPS 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)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 63479-0214-1, 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: 63479-0214-01, written without dashes as 63479021401. 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 63479-0214-01, the first segment (63479) is the labeler code FDA assigned to Apex Energetics Inc.; the middle segment (0214) 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 Apex Energetics Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Apex Energetics 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 22 words ▾

Uses: For temporary relief of minor: coughing* wheezing* congestion* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 38 words ▾

Directions: Adults & children ages 12 years and over: Take 10 drops under the tongue 3-4 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

⚠️ Warnings 70 words ▾

Warnings: If pregnant or breastfeeding , ask a health professional before use. Do not use if clear seal over the cap is broken or missing. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if coughing, wheezing, congestion, or other symptoms do not improve within 7 days or are accompanied by fever.

🧪 Active Ingredient 60 words ▾

Active Ingredients Belladonna 4X Blatta Orientalis 3X Coccus Cacti 4X Corallium Rubrum 10X Cuprum Metallicum 10X Drosera Rotundifolia 2X Echinacea Angustifolia 1X Hedera Helix 3X Hydrastis Canadensis 2X Ipecacuanha 4X 8X 10X 15X 30X Kali Nitricum 8X Lac Vaccinum 10X 12X 15X 30X Lobelia Inflata 3X Passiflora Incarnata 1X Pertussinum 30X Sambucus Nigra 1X Thymus Serpyllum 1X Valeriana Officinalis 1X

🧪 Inactive Ingredients 8 words ▾

Inactive Ingredients alcohol (20% by volume), distilled water

🎯 Purpose 22 words ▾

Uses: For temporary relief of minor: coughing* wheezing* congestion* *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 ↗

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