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Umcka Menthol Pelargonium sidoides 1 [hp_X]/120mL Syrup — NDC 53499-5272-5 (Billing 53499-5272-05)

by Schwabe North America, Inc · 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC

This is a package of Umcka Menthol Pelargonium sidoides 1 [hp_X]/120mL Syrup from Schwabe North America, Inc, marketed since Jan 2006 and currently FDA-listed, this package's marketing is listed to end Jul 2027. It is the main listing for this product, which comes in 2 package sizes.

NDC 53499-5272-05
🏷️ FDA NDC (as labeled) 53499-5272-5 billing pads the package segment with a zero
This package
Contains120 mL in 1 bottle, plastic Pack sizes2 compare ↓
Main listing for product 53499-5272 · Also comes in: 240 mL 53499-5272-9
OTC On market Non-controlled ⇄ 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 53499-5272-5 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53499 labeler · 5272 product · 5 package
Package marketed since
Jan 1, 2006
Package marketing ended
Jul 31, 2027
Sample package
No — commercial package
Barcode (UPC)
0033674152720
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53499-5272-5
Product NDC 53499-5272
11-digit billing NDC 53499527205
NCPDP billing unit ML — per mL (volume)
UNII H6J53HEX8E
UPC 0033674152720
SPL Set ID a3d94c70-3d62-44a8-bdae-39b07e8e0e36
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-01-01
Marketing end 2027-07-31
Route ORAL
Dosage form SYRUP
Substance PELARGONIUM SIDOIDES ROOT
Why two NDCs? The FDA registers this code as 53499-5272-5 — 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 → 53499-5272-05. 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 Menthol is a homeopathic syrup taken by mouth that contains pelargonium sidoides root as its active ingredient. In homeopathic practice, pelargonium sidoides is traditionally used to support respiratory health and address symptoms associated with colds and coughs. This is a homeopathic product marketed based on homeopathic tradition and has not been evaluated by the FDA for effectiveness.

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: 240 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
53499-5272-05 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC 2006-01-01 Jul 31, 2027 Active
53499-5272-09 53499-5272-9 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC 2006-01-01 Jul 31, 2027 Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Umcka Menthol Pelargonium sidoides 1 [hp_X]/120mL Syrup?
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 Zero Sugar Grape 1 [hp_X]/120mL 53499-6794-05 Schwabe 1 bottle — — FDA listed —
Umcka Menthol 1 [hp_X]/120mLthis 53499-5272-05 Schwabe 1 bottle — — FDA listed —
Cold Relief Syrup Kids Cherry 1 [hp_X]/120mL 53499-1165-05 Schwabe 1 bottle — — FDA listed —
ViraClear EPs 7630 Cherry Flavor 1 [hp_X]/120mL 59800-8002-05 Schwabe 1 bottle — — FDA listed —
Cold Relief Menthol 1 [hp_X]/120mL 53499-6272-05 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

🏛️
2006
On the market since
Jan 2006
📍
2026
Currently FDA-listed
20 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerSchwabe North America, Inc
Labeler code53499
First marketedJan 2006
Product typeHuman Otc Drug
Portfolio20 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 22 words ▾

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

⏱️ Dosage and Administration 58 words ▾

Dosage & Administration Directions For best results, use at first sign of symptoms. Continue to use for an additional 48 hours after symptoms cease Use only with enclosed dosage cup. Adults & children 12 years of age and older: Take 1 ½ teaspoon (tsp) (7.5 mL) 3 times daily. Children under 12 years of age: Consult a physician.

⚠️ Warnings 33 words ▾

Warnings Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting, or rash may be serious. Consult a physician promptly.

🆘 Overdosage 15 words ▾

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

🧪 Active Ingredient 5 words ▾

Active Ingredient Pelargonium sidoides 1X

🧪 Inactive Ingredients 12 words ▾

Inactive Ingredient Ethyl Alcohol Fructose Glycerin Maltodextrin Menthol Natural Flavor Purified Water

🎯 Purpose 20 words ▾

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

📄 Ask a Doctor Before Use If 36 words ▾

Ask Doctor Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus).

📄 Stop Use and Ask a Doctor If 52 words ▾

Stop Use Stop use and ask the doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or 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 3 words ▾

15272_Umcka Menthol Syrup_A01.jpg

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

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 Umcka Menthol (this brand).

Top reported reactions

Drug-induced Liver Injury2
Hepatotoxicity2
Liver Disorder2
Acute Hepatic Failure1
Alcoholic Liver Disease1
Allergic Granulomatous Angiitis1
Anaemia1

Reporter sex

0 reports
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Umcka Menthol Pelargonium sidoides 1 [hp_X]/120mL 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 it is currently marketed — but Schwabe North America, Inc has reported a marketing end date of 2027-07-31, after which this package is expected to stop being marketed. 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 (53499-5272-09). 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.
← 53499-5271-04 · Schwabe 53499-5295-00 · 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.