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Coldcalm ONION, APIS MELLIFERA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS 3 [hp_C]/1; 15 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1 Liquid — NDC 00220-9057-09 package photo

Coldcalm ONION, APIS MELLIFERA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS 3 [hp_C]/1; 15 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1 Liquid

by Laboratoires Boiron · 1 POUCH in 1 PACKAGE (0220-9057-09) / 30 LIQUID in 1 POUCH
NDC 00220-9057-09
🏷️ FDA NDC (as labeled) 0220-9057-09 billing pads the labeler segment with a zero
This package
Contains30 liquid in 1 pouch Pack sizes3 compare ↓
Also comes in: 1 pouch 00220-9057-07 1 pouch 00220-9057-47
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 0220-9057-09
Product NDC 0220-9057
11-digit billing NDC 00220905709
UNII 492225Q21H, 7S82P3R43Z, 1W0775VX6E, 639KR60Q1Q, T4423S18FM, 269XH13919 +2 more
UPC 0306969057094
SPL Set ID 94afe9a0-2d11-11e7-818f-424c58303031
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 2017-05-01
Route ORAL
Dosage form LIQUID
Substance ONION; APIS MELLIFERA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS
Why two NDCs? The FDA registers this code as 0220-9057-09 — 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 → 00220-9057-09. 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

LabelerLaboratoires Boiron
Labeler code00220
First marketedMay 2017
Product typeHuman Otc Drug
Portfolio40 products on file
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?

Coldcalm Onion is an unapproved homeopathic liquid taken by mouth. It contains multiple plant and mineral ingredients, including onion, several plant extracts (eupatorium, gelsemium, phytolacca, and pulsatilla), bee venom, and potassium dichromate, each diluted to homeopathic potencies. In homeopathic practice, these ingredients are traditionally used to address cold and flu-like symptoms, though homeopathic products are not evaluated by the FDA for effectiveness and are marketed based 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.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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.

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

The official label also statesalcohol, purified water

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.

💲 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.
Try another pack size: 1 pouch 1 pouch
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coldcalm 3 [hp_C]/1; 15 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]this 00220-9057-09 Laboratoires 1 pouch — — 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

🏛️
2017
On the market since
May 2017
📍
2026
Currently FDA-listed
9 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for COLDCALM (this brand).

Top reported reactions

Abdominal Pain2
Cardiomegaly2
Constipation2
Cough2
Dry Skin2
Fatigue2
Hallucination2

Reporter sex

0 reports
Male · 17%
Female · 83%

Serious outcomes

Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00220-9057-07 1 POUCH in 1 PACKAGE (0220-9057-07) / 5 LIQUID in 1 POUCH 2017-05-01 Active
00220-9057-09 You're viewing this 1 POUCH in 1 PACKAGE (0220-9057-09) / 30 LIQUID in 1 POUCH 2017-05-01 Active
00220-9057-47 1 POUCH in 1 PACKAGE (0220-9057-47) / 40 LIQUID in 1 POUCH 2023-09-13 Active

Pack size FAQ

What quantity is in NDC 00220-9057-09?
NDC 00220-9057-09 is listed by the FDA — 1 pouch in 1 package / 30 liquid in 1 pouch.
What NDC number is used to bill for this package of Coldcalm ONION, APIS MELLIFERA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS 3 [hp_C]/1; 15 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1 Liquid?
Bill NDC 00220-9057-09 — the 11-digit billing format is 00220905709. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Coldcalm ONION, APIS MELLIFERA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS 3 [hp_C]/1; 15 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1; 6 [hp_C]/1; 3 [hp_C]/1; 6 [hp_C]/1 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 FDA registers it as 0220-9057-09, 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: 00220-9057-09, written without dashes as 00220905709. 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 00220-9057-09, the first segment (00220) is the labeler code FDA assigned to Laboratoires Boiron; the middle segment (9057) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 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 2 other package presentations of this same product, including 1 pouch (00220-9057-07), 1 pouch (00220-9057-47). 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.

📄 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 12 words ▾

Uses* temporarily relieves cold symptoms such as: sneezing runny nose nasal congestion

⏱️ Dosage and Administration 62 words ▾

Directions Children 6 months of age and older: Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement. Children under 6 months of age: Ask a doctor. Tear open the foil pouch at the notched edge. Snap off one pre-measured dose. Twist to open. Holding the child upright, squeeze entire contents into mouth.

⚠️ Warnings 60 words ▾

Stop use and ask doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100 o F (38 o C) develops, or if symptoms persist for more than 2 days or worsen, or new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 99 words ▾

Active Ingredients Active ingredients** (in each 1mL vial) Allium cepa 3C HPUS (0.125 mL) Apis mellifica 15C HPUS (0.125 mL) Eupatorium perfoliatum 3C HPUS (0.125 mL) Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 -11 mg gelsemine alkaloids) Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 -10 mg chromium) Nux vomica 3C HPUS (0.125 mL) (contains less than 10 -5 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.125 mL) Pulsatilla 6C HPUS (0.125 mL) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 3 words ▾

alcohol, purified water

🎯 Purpose 78 words ▾

Purpose Purpose* Allium cepa 3C HPUS ... Relieves sneezing and runny nose Apis mellifica 15C HPUS ... Relieves nasal congestion Eupatorium perfoliatum 3C HPUS ...

Relieves body aches 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 mild fever Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00220-9055-82 · Boiron 00220-9059-04 · 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.