NDC 53499-6273-09 — Cold Relief Syrup Cherry Pelargonium sidoides

🆔 Identity & classification

FDA NDC (as labeled) 53499-6273-9

Product NDC 53499-6273

11-digit billing NDC 53499627309

NCPDP billing unit ML — per mL (volume)

UNII H6J53HEX8E

UPC 0033674152737

SPL Set ID cf5e01bb-ff17-4a72-b02d-4c3296795947

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-08-25

Route ORAL

Dosage form SYRUP

Substance PELARGONIUM SIDOIDES ROOT

Why two NDCs? The FDA registers this code as 53499-6273-9 — 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 → 53499-6273-09. 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

LabelerSchwabe North America, Inc

Labeler code53499

First marketedAug 2023

Product typeHuman Otc Drug

Portfolio20 products on file

🔎 All NDCs from Schwabe North America, Inc

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?

This is an unapproved homeopathic syrup taken by mouth that contains pelargonium sidoides root. In homeopathic practice, pelargonium sidoides is traditionally used to support respiratory and cold symptoms. Homeopathic products are marketed based on traditional use and homeopathic theory rather than evaluation by the FDA for safety or effectiveness. The potency and preparation method follow homeopathic principles.

Patient education

📘 MedlinePlus patient leaflet ↗

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 XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
UNII D2EVP827PJ
A juice extract from aronia berries, a dark purple fruit. It's used as a natural colorant and flavoring agent to add color and taste to the medication.
UNII 6YSS42VSEV
Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
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 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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.

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

The official label also statesAronia Juice Citric Acid Ethyl Alcohol Fructose Glycerin Maltodextrin Natural Flavor Potassium Sorbate 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 system	Per mL	Per 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: 120 mL

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Cold Relief Syrup Cherry 1 [hp_X]/240mLthis 53499-6273-09	Schwabe	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

🏛️

2023

On the market since

Aug 2023

📍

2026

Currently FDA-listed

3 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 Cold Relief Syrup Cherry (this brand).

Top reported reactions

Drug-induced Liver Injury2

Hepatotoxicity2

Liver Disorder2

Acute Hepatic Failure1

Alcoholic Liver Disease1

Allergic Granulomatous Angiitis1

Anaemia1

Reporter sex

Male · 67%

Female · 33%

Serious outcomes

Hospitalization4

Life-threatening1

Death1

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 NDC	Description	Marketing start	Status
53499-6273-05	1 BOTTLE, PLASTIC in 1 CARTON (53499-6273-5) / 120 mL in 1 BOTTLE, PLASTIC	2023-08-25	Active
53499-6273-09 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (53499-6273-9) / 240 mL in 1 BOTTLE, PLASTIC	2023-08-25	Active

Pack size FAQ

What quantity is in NDC 53499-6273-09?

NDC 53499-6273-09 is listed by the FDA — 1 bottle, plastic in 1 carton / 240 ml in 1 bottle, plastic.

What NDC number is used to bill for this package of Cold Relief Syrup Cherry Pelargonium sidoides 1 [hp_X]/240mL Syrup?

Bill NDC 53499-6273-09 — the 11-digit billing format is 53499627309. 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

Cold Relief Syrup Cherry Pelargonium sidoides 1 [hp_X]/240mL SYRUP 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	— Not published for this NDC No photo available yet for this listing.
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 53499-6273-9, 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: 53499-6273-09, written without dashes as 53499627309. 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 53499-6273-09, the first segment (53499) is the labeler code FDA assigned to Schwabe North America, Inc; the middle segment (6273) 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 Schwabe North America, Inc. 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 1 other package presentation of this same product, including 1 bottle (53499-6273-05). 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?

Schwabe North America, 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.

📄 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

🎯 Indications and Usage 27 words ▾

Indications and Usage Section Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

⏱️ Dosage and Administration 131 words ▾

Dosage & Administration: For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. Shake well before each use. Use only with enclosed dosage cup.

Adults and children 13 years of age and older: Take 1 ½ teaspoon (tsp) (7.5 mL) three times daily. Children 6-12 years of age: Take 1 teaspoon (5 mL) three times daily. Children 1-5 years of age: Take ½ teaspoon (2.5 mL) three times daily.

Indications and Usage Section Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat. Purpose Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

⚠️ Warnings 168 words ▾

Warnings Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask Doctor Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family. Stop Use Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition. Pregnancy or Breast Feeding If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children Keep out of reach of children.

Overdose In case of overdose, seek medical help or contact a Poison Control Center right away.

🆘 Overdosage 16 words ▾

Overdose In case of overdose, seek medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 22 words ▾

Active Ingredient Pelargonium sidoides 1X Inactive Ingredients Aronia Juice Citric Acid Ethyl Alcohol Fructose Glycerin Maltodextrin Natural Flavor Potassium Sorbate Purified Water

🧪 Inactive Ingredients 17 words ▾

Inactive Ingredients Aronia Juice Citric Acid Ethyl Alcohol Fructose Glycerin Maltodextrin Natural Flavor Potassium Sorbate Purified Water

🎯 Purpose 24 words ▾

Purpose Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

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

🔗 Related NDC lookups

🧪 All Pelargonium Sidoides NDCsSame ingredient 🏭 All Schwabe labeler NDCsLabeler code 53499