Home › NDC Lookup › Ingredients › Pelargonium Sidoides › 53499-5271-08
Umcka ColdCare Alcohol-Free Pelargonium sidoides 1 [hp_X]/30mL Liquid — NDC 53499-5271-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Umcka ColdCare Alcohol-Free Pelargonium sidoides 1 [hp_X]/30mL Liquid — NDC 53499-5271-8 (Billing 53499-5271-08)

by Schwabe North America, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 60 mL in 1 BOTTLE, DROPPER

This is a package of Umcka ColdCare Alcohol-Free Pelargonium sidoides 1 [hp_X]/30mL Liquid from Schwabe North America, Inc., no longer marketed (first marketed Feb 2009), no longer in the FDA NDC Directory.

NDC 53499-5271-08
🏷️ FDA NDC (as labeled) 53499-5271-8 billing pads the package segment with a zero
This package
Contains60 mL in 1 bottle, dropper Pack sizes2 compare ↓
Product page 53499-5271-04 Also comes in: 30 mL 53499-5271-4
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 53499-5271-8 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53499 labeler · 5271 product · 8 package
Barcode (UPC)
0033674152713
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53499-5271-8
Product NDC 53499-5271
11-digit billing NDC 53499527108
UNII H6J53HEX8E
UPC 0033674152713
SPL Set ID 5c647ae9-6c14-4661-aba3-53e9e4756edc
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2009-02-02
Marketing end 2027-02-28
Route ORAL
Dosage form LIQUID
Substance PELARGONIUM SIDOIDES ROOT
Why two NDCs? The FDA registers this code as 53499-5271-8 — 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 → 53499-5271-08. 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?

Umcka ColdCare is an alcohol-free oral liquid marketed as a homeopathic product. It contains pelargonium sidoides root, which is used in homeopathic practice traditionally associated with respiratory and cold symptoms. Homeopathic products are based on traditional use rather than FDA evaluation for effectiveness. This product is not approved by the FDA and should be discussed with a healthcare provider before use, especially if you are taking other medications.

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 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: 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53499-5271-04 53499-5271-4 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER 2009-02-02 Feb 28, 2027 Active
53499-5271-08 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 60 mL in 1 BOTTLE, DROPPER 2009-02-02 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 60 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Umcka ColdCare Alcohol-Free Pelargonium sidoides 1 [hp_X]/30mL Liquid?
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
Cold Relief Drops 1 [hp_X]/30mL 53499-8271-04 Schwabe 1 bottle — — FDA listed —
Cold Relief 1 [hp_X]/30mL 53499-7270-04 Schwabe 1 bottle — — FDA listed —
Umcka Original ColdCare 1 [hp_X]/30mL 53499-6270-04 Schwabe 1 bottle — — Discontinued —
ViraClear EPs 7630 Original 1 [hp_X]/30mL 59800-8001-04 Schwabe 1 bottle — — FDA listed —
Umcka ColdCare Alcohol-Free 1 [hp_X]/30mLthis 53499-5271-08 Schwabe 1 bottle — — Discontinued —
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

🏛️
2009
On the market since
Feb 2009
📍
2026
Currently FDA-listed
17 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 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 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statescitric acid ethyl alcohol glycerin maltodextrin potassium sorbate purified water sorbitol

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

LabelerSchwabe North America, Inc.
Labeler code53499
First marketedFeb 2009
Product typeHuman Otc Drug
Portfolio27 products on file

More NDCs from Schwabe North America, Inc. labeler code 53499

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 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

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

⏱️ Dosage and Administration 68 words ▾

Dosage & Administration Directions: For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. Adults & children 13 years of age and older: Take 1.5 mL three times daily by mouth. Children 6-12 years of age: Take 1 mL three times daily by mouth. Children 1-5 years of age: Take 0.5 mL three times daily by mouth.

⚠️ Warnings 30 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.

🆘 Overdosage 16 words ▾

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

🧪 Active Ingredient 5 words ▾

Active Ingredient PELARGONIUM SIDOIDES 1x

🧪 Inactive Ingredients 13 words ▾

Inactive Ingredient citric acid ethyl alcohol glycerin maltodextrin potassium sorbate purified water sorbitol

🎯 Purpose 21 words ▾

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

📄 Ask a Doctor Before Use If 46 words ▾

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 and Ask a Doctor If 50 words ▾

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.

🤰 If Pregnant or Breast-Feeding 14 words ▾

Pregnancy or Breast Feeding If pregnant or breast-feeding, ask a healthcare professional before use.

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children. Keep out of reach of children.

📄 Package Label / Principal Display Panel 11 words ▾

Add image transcription here... LGBN15271.B03 Umcka Orig

99.9Alcoh-Free Liq 1oz.jpg

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 No longer marketed (per FDA listing data)

About homeopathic listings

Umcka ColdCare Alcohol-Free Pelargonium sidoides 1 [hp_X]/30mL 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (53499-5271-04). 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.
← 53499-5182-00 · Schwabe 53499-5272-05 · Schwabe →
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.