Home › NDC Lookup › Ingredients › Aconitum Napellus, Allium Cepa, Gelsemiu... › 54973-3010-01
COLD Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 2 [hp_X]/g Tablet, 1 bottle — NDC 54973-3010-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

COLD Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 2 [hp_X]/g Tablet, 1 bottle — NDC 54973-3010-1 (Billing 54973-3010-01)

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

This is a package of 1 bottle of COLD Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 2 [hp_X]/g Tablet from Hyland's Inc., marketed since Feb 1997 and currently FDA-listed. It is this product's only package size.

NDC 54973-3010-01
🏷️ FDA NDC (as labeled) 54973-3010-1 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 Jul 24, 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 54973-3010-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54973 labeler · 3010 product · 1 package
Package marketed since
Feb 17, 1997
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0354973301016
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54973-3010-1
Product NDC 54973-3010
11-digit billing NDC 54973301001
UNII U0NQ8555JD, 639KR60Q1Q, 492225Q21H, U6WSN5SQ1Z
UPC 0354973301016
SPL Set ID 120c1c96-dd70-4d54-e054-00144ff8d46c
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 1997-02-17
Route ORAL
Dosage form TABLET
Substance ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; ONION; ZINC GLUCONATE
Why two NDCs? The FDA registers this code as 54973-3010-1 — 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 → 54973-3010-01. 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 an unapproved homeopathic oral tablet containing aconitum napellus, gelsemium sempervirens root, onion, and zinc gluconate. In homeopathic practice, these ingredients are traditionally used to address symptoms associated with the common cold, such as congestion, chills, and general malaise. Homeopathic products are marketed based on traditional use rather than clinical evidence, and the FDA does not evaluate homeopathic products for safety or effectiveness before they are sold.

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.
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
54973-3010-01 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 1 g in 1 BOTTLE, PLASTIC 1997-02-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 2 [hp_X]/gthis 54973-3010-01 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

🏛️
1997
On the market since
Feb 1997
📍
2026
Currently FDA-listed
29 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 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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.

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

LabelerHyland's Inc.
Labeler code54973
First marketedFeb 1997
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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use 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 40 words ▾

Uses ■ Reduces the duration and severity of common cold symptoms ■ Temporarily relieves symptoms of common cold, including: ■ sneezing ■ runny nose ■ congestion ■ cough ■ sore throat ■ headache ■ watery eyes ■ fever ■ chills

⏱️ Dosage and Administration 35 words ▾

Directions Adults and children 12 years and over Dissolve 2 tablets under tongue every 4 hours until relieved. Children 6 years to under 12 years Dissolve 1 tablet under tongue every 4 hours until relieved.

⚠️ Warnings 180 words ▾

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever (over 101°F) or infection is present or develops. ■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache.

Keep this and all medications out of the reach of children. 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 fever (over 101°F), headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency or accidental overdose, 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.

🆘 Overdosage 38 words ▾

In case of emergency or accidental overdose, 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 55 words ▾

Active ingredients Purpose Aconitum Napellus 6X HPUS sneezing, watery eyes, sore throat Allium Cepa 6X HPUS red/watery eyes, runny nose, nasal discharge Gelsemium Sempervirens 6X HPUS sneezing, headache, sore throat, cough Zincum Gluconicum 2X HPUS runny nose, sore throat "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients Acacia Gum, Lactose.

🎯 Purpose 11 words ▾

Relieves Runny Nose, Congestion, Sore Throat, Cough, Sneezing, Headache and Fever

📄 Do Not Use 37 words ▾

Do not use more than directed.

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.

📄 Ask a Doctor Before Use If 42 words ▾

Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever (over 101°F) or infection is present or develops. ■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache.

🤰 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 11 words ▾

Keep this and all medications out of the reach of children.

📄 Other Information 20 words ▾

Other information ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

📄 Questions or Comments 5 words ▾

Questions or comments? (800) 624-9659

📄 Recent Major Changes 83 words ▾

Indications and Usage (Uses) Updated to  Reduces the duration and severity of common cold symptoms  Temporarily relieves symptoms of common cold, including:  sneezing  runny nose  congestion  cough  sore throat  headache  watery eyes  fever  chills

Dosage and Administration Directions Adults and children 12 years and over Dissolve 2 tablets under tongue every 4 hours until relieved. Children 6 years to under 12 years Dissolve 1 tablet under tongue every 4 hours until relieved.

📄 Package Label / Principal Display Panel 54 words ▾

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL HOMEOPATHIC NDC 54973-3010-1 AGES 6+ SINCE 1903 Hyland's Cold Tablets with Zinc* SHORTENS COLDS MULTI - SYMPTOM RELIEF Relieves Runny Nose, Congestion, Sore Throat, Cough, Sneezing, Headache and Fever Free of Dyes and Preservatives Non-Drowsy 50 QUICK-DISSOLVING TABLETS NATURAL RELIEF *SEE NOTE ON SIDE PANEL BELOW DRUGS FACTS 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

COLD Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 2 [hp_X]/g 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.
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.
← 54973-2956-01 · Hyland's 54973-3012-01 · 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.