Tusnel-DM Pediatric Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 2.5 mg/mL; 25 mg/mL; 1.25 mg/mL Solution/ Drops, 30 mL — NDC 54859-0606-01 package photo

Tusnel-DM Pediatric Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 2.5 mg/mL; 25 mg/mL; 1.25 mg/mL Solution/ Drops, 30 mL

by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION · 30 mL in 1 BOTTLE, DROPPER (54859-606-01)
NDC 54859-0606-01
🏷️ FDA NDC (as labeled) 54859-606-01 billing pads the product segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 54859-606-01
Product NDC 54859-606
11-digit billing NDC 54859060601
NCPDP billing unit ML — per mL (volume)
RxCUI 2268062
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID 64e36b02-b5be-4d20-8818-cb5b23596671
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-01
Route ORAL
Dosage form SOLUTION/ DROPS
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
GPI-14 43997303100937
GPI class Tusnel-DM Pediatric
GCN Seq No 081519
GCN 48657
HICL code 000216
Ingredient (HICL) Guaifen/Dextromethorphan/Pe
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4R
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Decongestant-Expectorant
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name TUSNEL-DM PED 2.5-25-1.25MG/ML
FDB brand name Tusnel-Dm Pediatric
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 54859-606-01 — a 5-3-2 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 product segment → 54859-0606-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio11 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

Label name TUSNEL-DM PED 2.5-25-1.25MG/ML Ingredient Guaifen/Dextromethorphan/Pe
🧪 What is this product?

Tusnel-DM Pediatric is an over-the-counter oral liquid (drops) containing three active ingredients commonly used to address cold and cough symptoms. Dextromethorphan is a cough suppressant, while guaifenesin functions as an expectorant to help thin mucus and make coughs more productive. Phenylephrine is a decongestant typically used to relieve nasal congestion. This product is marketed as an OTC monograph drug, meaning it follows FDA's established guidelines for combination cold and cough remedies.

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 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients:  Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

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 DailyMedingredient 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 $0.285 $8.54 / 30 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 Aug 2026 $0.293 $0.284
Flat over the last 5 months.
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
Tusnel-DM Pediatric 2.5 mg/mL; 25 mg/mL; 1.25 mg/mLthis 54859-0606-01 LLORENS 30 ml $0.285 Availability likely
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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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 Tusnel-DM Pediatric (this brand).

Top reported reactions

Cough2
Fatigue1
Insomnia1
Pain1
Pyrexia1
Sinusitis1
Vertigo1

Age at onset

Adult1

Reporter sex

2 reports
Female · 100%
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
54859-0606-01 You're viewing this 30 mL in 1 BOTTLE, DROPPER (54859-606-01) 2019-08-01 Active

📄 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 43 words

Uses Temporary relief of cough due to minor throat and bronchial irritation Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

⏱️ Dosage and Administration 49 words

Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor. Age Weight Dose Children 2 to under 6 years of age 24-47 lbs Take 2 mL every 4-6 hours Children under 2 years of age Under 24 lbs Ask a doctor

⚠️ Warnings 166 words

Warnings Do not use in child whos is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI: ask your doctor or pharmacist before giving this product. Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that occurs with too much phlegm a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product do not exceed the recommended dosage. Stope use and ask doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

🧪 Active Ingredient 17 words

Active Ingredients in each (1 mL) Dextromethorphan HBr 2.5 mg Guaifenesin 25 mg Phenylephrine HCl 1.25 mg

🧪 Inactive Ingredients 20 words

Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

🎯 Purpose 6 words

Purpose Cough suppressant Expectorant Nasal Decongestant

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