Home › NDC Lookup › Ingredients › Onion, Calcium Sulfide, Sodium Chloride,... › 54973-3400-01
4 Kids Cold and Cough Daytime onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal 12 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL Liquid — NDC 54973-3400-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

4 Kids Cold and Cough Daytime onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal 12 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL Liquid — NDC 54973-3400-1 (Billing 54973-3400-01)

by Hyland's Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 148 mL in 1 BOTTLE, PLASTIC

This is a package of 4 Kids Cold and Cough Daytime onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal 12 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL Liquid from Hyland's Inc., marketed since Aug 2008 and currently FDA-listed. It is this product's only package size.

NDC 54973-3400-01
🏷️ FDA NDC (as labeled) 54973-3400-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 54973-3400-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54973 labeler · 3400 product · 1 package
Package marketed since
Aug 1, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0354973340015
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54973-3400-1
Product NDC 54973-3400
11-digit billing NDC 54973340001
UNII 1MBW07J51Q, 451W47IQ8X, 70FD1KFU70, 27YLU75U4W, I76KB35JEV, ZW3Z11D0JV +1 more
UPC 0354973340015
SPL Set ID 804e0e7a-20eb-128b-e053-2991aa0aa82c
Established class (EPC) Non-Standardized Food Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Vegetable Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-08-01
Route ORAL
Dosage form LIQUID
Substance CALCIUM SULFIDE; SODIUM CHLORIDE; SULFUR; PHOSPHORUS; ANEMONE PULSATILLA; GOLDENSEAL; ONION
Why two NDCs? The FDA registers this code as 54973-3400-1 — 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 → 54973-3400-01. 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.

Clinical

🧪 What is this product?

This is a homeopathic liquid preparation taken by mouth marketed for daytime cold and cough relief in children. It contains seven ingredients including onion, goldenseal, pulsatilla, sulfur, calcium sulfide, phosphorus, and sodium chloride in homeopathic dilutions. Homeopathic products are based on traditional homeopathic practice rather than standard medical evidence, and the FDA does not evaluate homeopathic products for effectiveness or safety. The ingredients are used in homeopathic tradition for symptoms associated with colds and coughs, though their effectiveness at the dilutions present in this product is not established by clinical research.

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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54973-3400-01 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 148 mL in 1 BOTTLE, PLASTIC 2008-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
4 Kids Cold and Cough Daytime 12 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mLthis 54973-3400-01 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

🏛️
2008
On the market since
Aug 2008
📍
2026
Currently FDA-listed
18 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.

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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

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

The official label also statesCitric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

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.

Manufacturer & labeler

LabelerHyland's Inc.
Labeler code54973
First marketedAug 2008
Product typeHuman Otc Drug
Portfolio69 products on file

More NDCs from Hyland's Inc. labeler code 54973

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.

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 📄 Do Not Use 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Uses Temporarily relieves the symptoms of the common cold including: nasal or chest congestion, runny nose, sore throat, sneezing, cough.

⏱️ Dosage and Administration 88 words ▾

Directions Measure only with the dosing cup provided Do not use dosing cup with other products On dosing cup, mL = milliliter, tsp = teaspoon Children 2 years to under 6 years 5 mL or 1 teaspoon up to 6 times per day (every 4 hours) Children 6 years to under 12 years 10 mL or 2 teaspoons up to 6 times per day (every 4 hours) Adults and children 12 years and over 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

⚠️ Warnings 200 words ▾

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if Symptoms persist for more than 7 days or worsen Inflammation, fever or infection develops Symptoms are accompanied by high fever (101°F). Cough tends to recur or is accompanied by high fever, rash or persistent headache Keep this and all medications out of the reach of children In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use this product For persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional. A persistent cough may be a sign of a serious condition. Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious.

Consult a doctor promptly. Do not use if imprinted tamper-evident bottle cap band is broken or missing. The inner packaged bottle is child-resistant In case of emergency contact a medical professional or Poison Control Center immediately.

Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

🧪 Active Ingredient 99 words ▾

Active ingredients Allium Cepa 6X HPUS Hepar Sulph Calc 12X HPUS Hydrastis 6X HPUS Natrum Muriaticum 6X HPUS Phosphorus 12X HPUS Pulsatilla 6X HPUS Sulphur 12X HPUS "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Purpose Allium Cepa 6X HPUS..........................watery/runny nose, cold, hacking cough, painful throat Hepar Sulph Calc 12X HPUS................cold, sneezing Hydrastis 6X HPUS................................rattling/tickling cough, sinus congestion, dry/raw/sore throat Natrum Muriaticum 6X HPUS................dry cough, sore throat Phosphorus 12X HPUS.........................hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS................................moist cough, cold, nasal congestion Sulphur 12X HPUS................................chest congestion, nasal congestion, sneezing, runny nose

🧪 Inactive Ingredients 11 words ▾

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

🎯 Purpose 56 words ▾

Purpose Allium Cepa 6X HPUS..........................watery/runny nose, cold, hacking cough, painful throat Hepar Sulph Calc 12X HPUS................cold, sneezing Hydrastis 6X HPUS................................rattling/tickling cough, sinus congestion, dry/raw/sore throat Natrum Muriaticum 6X HPUS................dry cough, sore throat Phosphorus 12X HPUS.........................hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS................................moist cough, cold, nasal congestion Sulphur 12X HPUS................................chest congestion, nasal congestion, sneezing, runny nose

📄 Do Not Use 44 words ▾

Do not use this product For persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

🤰 If Pregnant or Breast-Feeding 13 words ▾

As with any drug, ask a doctor before use if pregnant or breast-feeding.

📄 Keep Out of Reach of Children 25 words ▾

Keep this and all medications out of the reach of children In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

📄 Questions or Comments 5 words ▾

Questions or comments? (800) 624-9659

📄 Package Label / Principal Display Panel 51 words ▾

Principal Display Panel - 148 mL Bottle Carton 25% MORE BONUS PACK NDC 54973-3400-1 HOMEOPATHIC Ages 2-12 NATURAL RELIEF SINCE 1903 Hyland's 4Kiids Cold 'n Cough* DAYTIME Congestion Runny Nose Sore Throat Sneezing Cough ALCOHOL FREE SUGAR FREE DYE FREE 4 + 1 = 5 S FL. OZ. (148 mL) Carton

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

4 Kids Cold and Cough Daytime onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal 12 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 6 [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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 54973-3379-01 · Hyland's 54973-3406-01 · Hylands →
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.