Home › NDC Lookup › Ingredients › Onion, Apis Mellifera, Atropa Belladonna... › 00220-9048-04
Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1 Tablet, 60-count — NDC 00220-9048-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1 Tablet, 60-count — NDC 0220-9048-04 (Billing 00220-9048-04)

by Laboratoires Boiron · 60 TABLET in 1 BLISTER PACK

This is a package of 60 tablets of Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1 Tablet from Laboratoires Boiron, marketed since Jan 1995 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 00220-9048-04
🏷️ FDA NDC (as labeled) 0220-9048-04 billing pads the labeler segment with a zero
This package
Contains60-count Pack sizes4 compare ↓
Main listing for product 0220-9048 · Also comes in: 20 tablets 0220-9048-91 100 tablets 0220-9048-92 120 tablets 0220-9048-29
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0220-9048-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0220 labeler · 9048 product · 04 package
Package marketed since
Jan 1, 1995
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0220904804 4
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0220-9048-04
Product NDC 0220-9048
11-digit billing NDC 00220904804
UNII 492225Q21H, 7S82P3R43Z, WQZ3G9PF0H, 1W0775VX6E, 639KR60Q1Q, 9LKY4BFN2V +3 more
SPL Set ID af4a4765-8255-44fb-821c-4345a2a45e2a
Established class (EPC) Non-Standardized Food Allergenic Extract; Standardized Insect Venom Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Dietary Proteins; Vegetable Proteins; Bee Venoms; 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 1995-01-01
Route ORAL
Dosage form TABLET
Substance ONION; APIS MELLIFERA; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; DICHROMATE ION; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99870010000700
GPI class Coldcalm
Quick answers
  • GPI-14 (Medi-Span): 99870010000700
Why two NDCs? The FDA registers this code as 0220-9048-04 — a 4-4-2 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 labeler segment → 00220-9048-04. 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?

Coldcalm is an unapproved homeopathic tablet taken by mouth. It contains multiple plant and animal-derived substances including onion, bee venom, nightshade alkaloids, and various plant extracts, all in homeopathic potencies. These ingredients are used in homeopathic practice for symptoms associated with colds and flu-like illnesses. Homeopathic products are marketed based on traditional homeopathic principles and have not been evaluated by the FDA for effectiveness or safety.

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: 20 tablets 100 tablets 120 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
00220-9048-04 You're viewing this Main listing 60 TABLET in 1 BLISTER PACK 1995-01-01 — Active
00220-9048-29 0220-9048-29 120 TABLET in 1 BLISTER PACK 2020-12-09 — Active
00220-9048-91 0220-9048-91 20 TABLET in 1 BLISTER PACK 2021-07-14 — Active
00220-9048-92 0220-9048-92 100 TABLET in 1 BLISTER PACK 2025-04-01 — Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 blister pack.
How does this package differ from NDC 00220-9048-91?
Both are Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1 Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 00220-9048-91 is the 20 tablets package.
What NDC number is used to bill for this package of Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/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
Coldcalm 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]this 00220-9048-04 Laboratoires 60 tablets — — 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

🏛️
1995
On the market since
Jan 1995
📍
2026
Currently FDA-listed
31 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

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

The official label also statescroscarmellose sodium, lactose, magnesium stearate

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

LabelerLaboratoires Boiron
Labeler code00220
First marketedJan 1995
Product typeHuman Otc Drug
Portfolio40 products on file

More NDCs from Laboratoires Boiron labeler code 00220

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 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Uses* temporarily relieves cold symptoms such as: sneezing runny nose nasal congestion occasional minor sore throat

⏱️ Dosage and Administration 59 words ▾

Directions Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets every 6 hours. Decrease frequency with improvement. Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

⚠️ Warnings 9 words ▾

Do not use if you are allergic to Apis.

🧪 Active Ingredient 108 words ▾

Active ingredients** (in each tablet) Allium cepa 3C HPUS (0.28 mg) Apis mellifica 6C HPUS (0.28 mg) Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids) Eupatorium perfoliatum 3C HPUS (0.28 mg) Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids) Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium) Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.28 mg) Pulsatilla 6C HPUS (0.28 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 5 words ▾

croscarmellose sodium, lactose, magnesium stearate

🎯 Purpose 93 words ▾

Purpose* Allium cepa 3C HPUS ... Relieves sneezing and runny nose Apis mellifica 6C HPUS ... Relieves nasal congestion Belladonna 6C HPUS ...

Relieves colds with a sudden onset Eupatorium perfoliatum 3C HPUS ... Relieves aches and pain associated with colds Gelsemium sempervirens 6C HPUS ... Relieves headaches associated with colds Kali bichromicum 6C HPUS ...

Relieves nasal discharge Nux vomica 3C HPUS .... Relieves sneezing fits Phytolacca decandra 6C HPUS ... Relieves occasional minor sore throat associated with colds Pulsatilla 6C HPUS ...

Relieves colds with a loss of taste and smell

📄 Ask a Doctor Before Use If 27 words ▾

Ask a doctor before use in children under 4 years of age if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if sore throat worsens or persists for more than 2 days nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults new symptoms occur

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 19 words ▾

Questions or comments ColdCalm.com BoironUSA.com [email protected] 1-800-BOIRON-1 (1-800-264-7661) Distributed by Boiron, Inc. Newtown Square, PA 19073 Made in France

📄 Package Label / Principal Display Panel 16 words ▾

label LABEL LABEL LABEL LABEL label label label label label label label label label label label

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

Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/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.
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 Laboratoires Boiron. 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 3 other package presentations of this same product, including 20 tablets (00220-9048-91), 100 tablets (00220-9048-92), 120 tablets (00220-9048-29). 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?
Laboratoires Boiron 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.
← 00220-9047-78 · Laboratoires 00220-9049-42 · Laboratoires →
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.