NDC 54973-3371-02 — Baby Nighttime Mucus Plus Cold Relief CALCIUM

🆔 Identity & classification

FDA NDC (as labeled) 54973-3371-2

Product NDC 54973-3371

11-digit billing NDC 54973337102

UNII 1MBW07J51Q, 27YLU75U4W, I76KB35JEV, ETJ7Z6XBU4, ZW3Z11D0JV, 492225Q21H +7 more

SPL Set ID 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3

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

Physiologic effect Increased Histamine Release; Cell-mediated Immunity

Chemical class Allergens; Dietary Proteins; Vegetable Proteins; Plant Proteins; Seed Storage Proteins

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-11-01

Route ORAL

Dosage form LIQUID

Substance CALCIUM SULFIDE; PHOSPHORUS; ANEMONE PULSATILLA; SILICON DIOXIDE; GOLDENSEAL; ONION; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; SODIUM CHLORIDE; RUMEX CRISPUS ROOT; SULFUR

Why two NDCs? The FDA registers this code as 54973-3371-2 — 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 → 54973-3371-02. 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 marketedNov 2018

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?

This is an unapproved homeopathic liquid taken by mouth that contains multiple plant and mineral ingredients. In homeopathic practice, ingredients such as pulsatilla, bryonia, goldenseal, chamomile, and onion are traditionally used to address cold and respiratory symptoms, while euphrasia is commonly included for eye-related discomfort. Homeopathic products are marketed based on homeopathic tradition and are not evaluated by the FDA for effectiveness. The specific potencies and uses described reflect homeopathic principles rather than established medical evidence.

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
Baby Nighttime Mucus Plus Cold Relief 12 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 3 [hp_X]/mLthis 54973-3371-02	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

🏛️

2018

On the market since

Nov 2018

📍

2026

Currently FDA-listed

8 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
54973-3371-02 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (54973-3371-2) / 118 mL in 1 BOTTLE, PLASTIC	2018-11-01	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Baby Nighttime Mucus Plus Cold Relief CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA and MATRICARIA CHAMOMILLA 12 [hp_X]/mL; 30 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [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)	— 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 54973-3371-2, 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: 54973-3371-02, written without dashes as 54973337102. 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 54973-3371-02, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (3371) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 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 ↗

🔗 Related NDC lookups

🧪 All Calcium Sulfide,Phosphorus,Sulfur,Rumex Crispus Root,Sodium Chloride,Arabica Coffee Bean,Anemone Pulsatilla,Silicon Dioxide, Goldenseal,Onion,Bryonia Alba Root,Euphrasia Stricta And Matricaria Chamomilla NDCsSame ingredient 🏭 All Hyland's labeler NDCsLabeler code 54973 📚 All Non-Standardized Food Allergenic Extract NDCsDrug class