NDC 54973-4086-01 — Bioplasma SILICON DIOXIDE,POTASSIUM

🆔 Identity & classification

FDA NDC (as labeled) 54973-4086-1

Product NDC 54973-4086

11-digit billing NDC 54973408601

UNII ETJ7Z6XBU4, 91D9GV0Z28, 91GQH8I5F7, HF539G9L3Q, 70WT22SF4B, 660YQ98I10 +6 more

SPL Set ID dd0a7ed2-d112-4b96-e053-2995a90ac6b6

Established class (EPC) Blood Coagulation Factor; Calculi Dissolution Agent; Cations; Increased Large Intestin

Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility

Chemical class Calcium; Divalent

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-12-06

Route ORAL

Dosage form TABLET, SOLUBLE

Substance SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SODIUM CHLORIDE; CALCIUM SULFATE A

Why two NDCs? The FDA registers this code as 54973-4086-1 — 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 → 54973-4086-01. 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

LabelerHyland's Inc.

Labeler code54973

First marketedDec 2021

Product typeHuman Otc Drug

Portfolio69 products on file

🔎 All NDCs from Hyland's 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?

Bioplasma is a soluble tablet taken by mouth that contains mineral salts and compounds including potassium, sodium, calcium, magnesium, phosphate, and sulfate. It is marketed as a homeopathic product based on traditional homeopathic use. Homeopathic products are not evaluated by the FDA for effectiveness. This product is sold over the counter and should not be confused with medicines reviewed and approved by the FDA.

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.

💊 What it looks like

Color white

ShapeRound

Size9 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.

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

The official label also statesAcacia Gum, Lactose.

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 each	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
Bioplasma 6 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]this 54973-4086-01	Hyland's	100 tablets	—	—	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

🏛️

2021

On the market since

Dec 2021

📍

2026

Currently FDA-listed

5 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 Bioplasma (this brand).

Top reported reactions

Drug Interaction3

Anxiety1

Asthenia1

Blood Iron Increased1

Drug Hypersensitivity1

Dyspnoea1

Ejection Fraction Abnormal1

Reporter sex

Male · 40%

Female · 60%

Serious outcomes

Hospitalization4

Life-threatening2

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
54973-4086-01 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (54973-4086-1) / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC	2021-12-06	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Bioplasma SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SUL 6 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1 TABLET, SOLUBLE 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	— Not published for this NDC No photo available yet for this listing.
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 54973-4086-1, 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: 54973-4086-01, written without dashes as 54973408601. 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 54973-4086-01, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (4086) 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 Hyland's Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Hyland's 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 14 words ▾

Uses ■ Temporarily relieves: ■ cold symptoms ■ nervous tension ■ fatigue ■ headaches

⏱️ Dosage and Administration 22 words ▾

Directions ■ Use as directed. ■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

⚠️ Warnings 134 words ▾

Warnings Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ redness, swelling, inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. ■ new symptoms occur. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children.

🧪 Active Ingredient 87 words ▾

Active ingredients Purpose Calc Fluor 6X HPUS cold symptoms Calc Phos 3X HPUS headaches Calc Sulph 3X HPUS cold symptoms Ferrum Phos 3X HPUS fatigue, headaches Kali Mur 3X HPUS cold symptoms, fatigue, headaches Kali Phos 3X HPUS headaches, nervous tension Kali Sulph 3X HPUS headaches Mag Phos 3X HPUS headaches, nervous tension Nat Mur 6X HPUS fatigue Nat Phos 3X HPUS fatigue, headaches, nervous tension Nat Sulph 3X HPUS cold symptoms, fatigue, headaches Silicea 6X HPUS fatigue "HPUS" is the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients Acacia Gum, Lactose.

🎯 Purpose 91 words ▾

Purpose Active ingredients Purpose* Calc Fluor 6X HPUS ................................................................................................cold symptoms Calc Phos 3X HPUS .......................................................................................................headaches Calc Sulph 3X HPUS ...............................................................................................cold symptoms Ferrum Phos 3X HPUS.................................................................................... fatigue, headaches Kali Mur 3X HPUS .............................................................. cold symptoms, fatigue, headaches Kali Phos 3X HPUS.......................................................................... headaches, nervous tension Kali Sulph 3X HPUS .......................................................................................................headaches Mag Phos 3X HPUS ........................................................................ headaches, nervous tension Nat Mur 6X HPUS ................................................................................................................. fatigue Nat Phos 3X HPUS............................................................fatigue, headaches, nervous tension Nat Sulph 3X HPUS............................................................ cold symptoms, fatigue, headaches Silicea 6X HPUS .................................................................................................................... fatigue "HPUS" is the Homeopathic Pharmacopoeia of the United States.

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

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