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Natures Way Cold Relief Hot Drink PELARGONIUM SIDOIDES WHOLE, PELARGONIUM SIDOIDES WHOLE, MATRICARIA CHAMOMILLA ROOT, HOPS, PASSIFLORA INCARNATA WHOLE Kit

by Universal Synergetics, Inc · 1 KIT in 1 KIT (80228-2060-1) * 5 g in 1 PACKET (80228-2040-1) * 5 g in 1 PACKET (80228-2050-1)
NDC 80228-2060-01
🏷️ FDA NDC (as labeled) 80228-2060-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 80228-2060-1
Product NDC 80228-2060
11-digit billing NDC 80228206001
SPL Set ID 0a3fa90a-de69-4d89-84cd-822c88be6406
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-01
Dosage form KIT
Why two NDCs? The FDA registers this code as 80228-2060-1 — 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 → 80228-2060-01. 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.

🏭 Manufacturer & labeler

LabelerUniversal Synergetics, Inc
Labeler code80228
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio6 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?

Natures Way Cold Relief Hot Drink is a kit product containing pelargonium sidoides, matricaria chamomilla root, hops, and passiflora incarnata. Pelargonium sidoides is commonly used in traditional herbal preparations for respiratory and cold symptoms. Matricaria chamomilla (chamomile) and hops are typical herbal ingredients used for their calming properties, while passiflora incarnata is traditionally used to support relaxation. This product is an unapproved over-the-counter drug and has not been evaluated by the FDA.

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.

From the label’s inactive-ingredient sectioncitric acid, maltodextrin, natural flavor, silica, turmeric color, xylitol citric acid, honey, lactose monohydrate, luo han guo, maltodextrin, natural flavor, silica, stevia (leaf) extract, turmeric color, xylitol

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Natures Way Cold Relief Hot Drinkthis 80228-2060-01 Universal 1 kit — — 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80228-2060-01 You're viewing this 1 KIT in 1 KIT (80228-2060-1) * 5 g in 1 PACKET (80228-2040-1) * 5 g in 1 PACKET (80228-2050-1) 2025-06-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 Drug Other". 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 80228-2060-1, 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: 80228-2060-01, written without dashes as 80228206001. 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 80228-2060-01, the first segment (80228) is the labeler code FDA assigned to Universal Synergetics, Inc; the middle segment (2060) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Universal Synergetics, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Universal Synergetics, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 59 words ▾

Uses • 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

Uses •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 200 words ▾

Directions • Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot. May also be dissolved in 4-6 ounces of cold water, which may be preferable for children. • for best results, use with Umcka® Cold Relief Hot Drink Night Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease age dose adults/children 13 years of age and older take 1 packet two times daily children 6-12 years of age take 1 packet daily children under 6 years of age consult a doctor

Directions • Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot. May also be dissolved in 4-6 ounces of cold water, which may be preferable for children. • for best results, use with Umcka® Cold Relief Hot Drink Day Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease age dose adults/children 13 years of age and older take 1 packet nightly 30-60 minutes before bed children 6-12 years of age take 1 packet nightly 30-60 minutes before bed children under 6 years of age consult a doctor

⚠️ Warnings ~1 min read ▾

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 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 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. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children.

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

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 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 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. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children.

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

🧪 Active Ingredient 49 words ▾

Active ingredient (in each packet) Pelargonium sidoides 1X Purpose Shortens duration and reduces severity of upper respiratory symptoms

Active ingredients (in each packet) Pelargonium sidoides 1X Chamomilla recutita 2X Humulus lupulus 1X Passiflora incarnata 1X Purpose Shortens duration and reduces severity of upper respiratory symptoms Helps with restful sleep††

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients citric acid, maltodextrin, natural flavor, silica, turmeric color, xylitol

Inactive ingredients citric acid, honey, lactose monohydrate, luo han guo, maltodextrin, natural flavor, silica, stevia (leaf) extract, turmeric color, xylitol

🎯 Purpose 24 words ▾

Purpose Shortens duration and reduces severity of upper respiratory symptoms

Purpose Shortens duration and reduces severity of upper respiratory symptoms Helps with restful sleep††

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80228-2001-01 · Universal 80228-2166-00 · Universal →
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.