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4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1 Tablet, 16-count — NDC 54973-3406-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1 Tablet, 16-count — NDC 54973-3406-2 (Billing 54973-3406-02)

by Hylands Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 16 TABLET in 1 BOTTLE, PLASTIC

This is a package of 16 tablets of 4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1 Tablet from Hylands Inc., no longer marketed (first marketed Jan 2020), no longer in the FDA NDC Directory.

NDC 54973-3406-02
🏷️ FDA NDC (as labeled) 54973-3406-2 billing pads the package segment with a zero
This package
Contains16-count Pack sizes2 compare ↓
Product page 54973-3406-01 Also comes in: 50 tablets 54973-3406-1
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 54973-3406-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54973 labeler · 3406 product · 2 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5497334062 6
FDA record last changed
Aug 27, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54973-3406-2
Product NDC 54973-3406
11-digit billing NDC 54973340602
UNII 2E32821G6I, ZW3Z11D0JV, T4423S18FM, 8E272251DI
SPL Set ID a00f1db3-cae4-5729-e053-2a95a90ab001
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2020-01-27
Route ORAL
Dosage form TABLET
Substance OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE
Why two NDCs? The FDA registers this code as 54973-3406-2 — 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 → 54973-3406-02. 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.

Clinical

🧪 What is this product?

This is an unapproved homeopathic oral tablet marketed for stuffy nose and sinus symptoms in children. It contains pulsatilla pratensis whole, goldenseal, oyster shell calcium carbonate, and potassium dichromate. In homeopathic practice, these ingredients are traditionally used in highly diluted form for various conditions, though homeopathic products are not reviewed by the FDA for safety or effectiveness and rely on homeopathic tradition rather than clinical evidence.

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 eachPer 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: 50 tablets
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
54973-3406-01 54973-3406-1 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET in 1 BOTTLE, PLASTIC 2020-01-27 — Active
54973-3406-02 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 16 TABLET in 1 BOTTLE, PLASTIC 2020-01-27 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This is a 16-count package — 1 bottle, plastic in 1 carton / 16 tablet in 1 bottle, plastic.
How does this package differ from NDC 54973-3406-01?
Both are 4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1 Tablet — the drug itself is identical. This page's package is the 16-count one, while NDC 54973-3406-01 is the 50 tablets package.
What NDC number is used to bill for this package of 4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1 Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
4 Kids Stuffy Nose and Sinus 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]this 54973-3406-02 Hylands 16 tablets — — Discontinued —
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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.

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.

Manufacturer & labeler

LabelerHylands Inc.
Labeler code54973
First marketedJan 2020
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from Hylands 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 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses ■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: ■ nasal congestion ■ sinus pressure ■ headache

⏱️ Dosage and Administration 101 words ▾

Directions ■ Use as directed. Children 2 years to under 6 years At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist, 1 tablet every 4 hours until relieved.

Children 6 years to under 12 years At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Adults and children 12 years and over At onset of symptoms, dissolve 3 tablets under tongue every hour up to 4 hours.

If symptoms persist, 3 tablets every 4 hours until relieved.

⚠️ Warnings 41 words ▾

Warnings Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children.

🧪 Active Ingredient 43 words ▾

Active ingredients Active ingredients Purpose Calcarea Carbonica 3X HPUS sinus pressure, congestion, headache Hydrastis Canadensis 6X HPUS sinus headache Kali Bichromicum 6X HPUS nasal congestion, sinus pressure Pulsatilla Nigricans 6X HPUS sinus pressure, headache "HPUS" is the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients Acacia Gum, Lactose.

🎯 Purpose 16 words ▾

Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 10 words ▾

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

📄 Questions or Comments 4 words ▾

Questions? www.hylands.com or [email protected]

📄 Recent Major Changes 21 words ▾

Indications and Usage Uses Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: nasal congestion sinus pressure headache

📄 Package Label / Principal Display Panel 28 words ▾

Principal Display Panel Hyland's •kids• STUFFY NOSE & SINUS* NO ARTIFICIAL FLAVORS, DYES or PARABENS Nasal Congestion Sinus Pressure Headache 2- 12 YEARS 50 QUICK-DISSOLVING TABLETS HOMEOPATHIC SSFK00000T50LBLH1

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 No longer marketed (per FDA listing data)

About homeopathic listings

4 Kids Stuffy Nose and Sinus PULSATILLA PRATENSIS WHOLE,OYSTER SHELL CALCIUM CARBONATE, CRUDE,GOLDENSEAL and POTASSIUM DICHROMATE 3 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1 TABLET 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 tablets (54973-3406-01). 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?
Hylands 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.
← 54973-3400-01 · Hyland's 54973-3431-01 · 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.