Home › NDC Lookup › Ingredients › Bryonia Alba Root, Euphrasia Stricta, Ca... › 54973-3284-01
BABY MUCUS PLUS COLD RELIEF bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 30 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL Liquid — NDC 54973-3284-01 package photo

BABY MUCUS PLUS COLD RELIEF bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 30 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL Liquid

by Hyland's Inc. · 1 BOTTLE, PLASTIC in 1 CARTON (54973-3284-1) / 118 mL in 1 BOTTLE, PLASTIC
NDC 54973-3284-01
🏷️ FDA NDC (as labeled) 54973-3284-1 billing pads the package segment with a zero
This package
Contains118 mL in 1 bottle, plastic Pack sizes2 compare ↓
Also comes in: 148 mL 54973-3284-03
OTC On market Non-controlled
🗂️ Data synced Sep 18, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 54973-3284-1
Product NDC 54973-3284
11-digit billing NDC 54973328401
UNII T7J046YI2B, C9642I91WL, 1MBW07J51Q, 451W47IQ8X, 27YLU75U4W, I76KB35JEV +2 more
SPL Set ID 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-05-13
Route ORAL
Dosage form LIQUID
Substance BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SILICON DIOXIDE; RUMEX CRISPUS ROOT
Why two NDCs? The FDA registers this code as 54973-3284-1 — 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 → 54973-3284-01. 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 marketedMay 2016
Product typeHuman Otc Drug
Portfolio69 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?

Baby Mucus Plus Cold Relief is an unapproved homeopathic liquid product taken by mouth. It contains eight plant and mineral ingredients, including bryonia alba, euphrasia stricta, anemone pulsatilla, and rumex crispus root, which are traditionally used in homeopathic practice for symptoms related to cold and congestion. Homeopathic products are marketed based on traditional homeopathic principles and are not evaluated by the FDA for safety or effectiveness.

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.

From the label’s inactive-ingredient sectionCitric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate. Citric Acid, Glycerine,Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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 systemPer mLPer 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.
Try another pack size: 148 mL
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baby Mucus Plus Cold Relief 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 30 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mLthis 54973-3284-01 Hyland's 1 bottle — — 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
May 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 NDCDescription Marketing startStatus
54973-3284-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (54973-3284-1) / 118 mL in 1 BOTTLE, PLASTIC 2016-05-13 Active
54973-3284-03 1 BOTTLE, PLASTIC in 1 CARTON (54973-3284-3) / 148 mL in 1 BOTTLE, PLASTIC 2018-08-01 Active

Pack size FAQ

What quantity is in NDC 54973-3284-01?
NDC 54973-3284-01 is listed by the FDA — 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of BABY MUCUS PLUS COLD RELIEF bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 30 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL Liquid?
Bill NDC 54973-3284-01 — the 11-digit billing format is 54973328401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

BABY MUCUS PLUS COLD RELIEF bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 30 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [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 54973-3284-1, 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: 54973-3284-01, written without dashes as 54973328401. 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 54973-3284-01, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (3284) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (54973-3284-03). Each has its own NDC and its own page — see the package list near the top of this page.
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 75 words ▾

Uses* ■ Helps temporarily relieve symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose ■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion

Uses* ■ Helps temporarily relieve symptoms of common cold in children at night, including: ■ accumulation of mucus in chest, throat or nose ■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion ■ occasional sleeplessness

⏱️ Dosage and Administration 170 words ▾

Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year 2.5 mL up to 4 times per day (every 6 hours). Children 1 year to under 3 years 5 mL up to 6 times per day (every 4 hours).

Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year 2.5 mL at bedtime and every 6 hours during the night until relieved.

Children 1 year to under 3 years 5 mL at bedtime and every 4 hours during the night until relieved.

⚠️ Warnings 205 words ▾

Warnings Ask a doctor before use if you have ■ persistent or chronic cough such as 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. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children

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 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. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. Keep out of reach of children

🧪 Active Ingredient ~1 min read ▾

Active ingredients Purpose* Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus Euphrasia Officinalis 6X HPUS cough with mucus in chest Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest Natrum Muriaticum 30X HPUS accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS cough with mucus, chest congestion Pulsatilla 6X HPUS accumulation of mucus, discharge of mucus, loose cough Rumex Crispus 6X HPUS runny nose, sneezing Silicea 12X HPUS nasal congestion HPUS" is the Homeopathic Pharmacopoeia of the United States.

Active ingredients Purpose* Allium Cepa 6X HPUS runny nose with mucus, hacking cough, sore throat Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus Chamomilla 3X HPUS occasional sleeplessness Coffea Cruda 3X HPUS occasional sleeplessness Euphrasia Offcinalis 6X HPUS cough with mucus in chest Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest Hydrastis 6X HPUS cough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat Natrum Muriaticum 6X HPUS accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS cough with mucus, chest congestion Pulsatilla 6X HPUS accumulation of mucus, discharge of mucus, loose cough Rumex Crispus 6X HPUS runny nose, sneezing Silicea 12X HPUS nasal congestion Sulphur 12X HPUS cough with thick mucus, chest congestion, nasal congestion "HPUS" is the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Inactive ingredients Citric Acid, Glycerine,Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

🎯 Purpose 32 words ▾

Helps temporarily relieve symptoms of common cold in children at night, including: accumulation of mucus in chest, throat or nose, cough with mucus, runny nose, sneezing, nasal or chest congestion, occasional sleeplessness.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54973-3274-01 · Hyland's 54973-3307-01 · Hyland's →
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.