Home › NDC Lookup › Ingredients › Guaifenesin › 54859-0507-04
Tusnel EX Guaifenesin 100 mg/5mL Liquid, 118 mL — NDC 54859-0507-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tusnel EX Guaifenesin 100 mg/5mL Liquid, 118 mL — NDC 54859-507-04 (Billing 54859-0507-04)

by Llorens Pharmaceutical International Division, Inc. · 118 mL in 1 BOTTLE

This is a package of 118 mL of Tusnel EX Guaifenesin 100 mg/5mL Liquid from Llorens Pharmaceutical International Division, Inc., marketed since May 2019 and currently FDA-listed; retail pharmacies pay about $0.0229 per mL (NADAC). It is this product's only package size.

NDC 54859-0507-04
🏷️ FDA NDC (as labeled) 54859-507-04 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 54859-507-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54859 labeler · 507 product · 04 package
Package marketed since
May 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
118 mL per package
Barcode (UPC-A, from the NDC)
3 5485950704 4
Medicaid fills, this package
4,975 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54859-507-04
Product NDC 54859-507
11-digit billing NDC 54859050704
NCPDP billing unit ML — per mL (volume)
RxCUI 310604
UNII 495W7451VQ
Application # M012
SPL Set ID 77c16288-68c4-476c-995f-86f505663270
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 2019-05-01
Route ORAL
Dosage form LIQUID
Substance GUAIFENESIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43200010000910
GPI class Tusnel-EX
GCN Seq No 022210
GCN 02512
HICL code 000271
Ingredient (HICL) Guaifenesin
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3J
Therapeutic class — specific (HIC3) Expectorants
AHFS code 48:16.00.00
AHFS class Expectorants
FDB label name TUSNEL-EX 100 MG/5 ML LIQUID
FDB brand name Tusnel-Ex
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 022210
  • GCN: 02512
  • GPI-14 (Medi-Span): 43200010000910
  • HICL (First Databank): 000271
  • AHFS class code: 48:16.00.00
  • RxCUI (RxNorm): 310604
Why two NDCs? The FDA registers this code as 54859-507-04 — 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 → 54859-0507-04. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
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.

Clinical

Label name TUSNEL-EX 100 MG/5 ML LIQUID Ingredient Guaifenesin
📖 What it is MedlinePlus · NLM

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin doesn't suppress your cough — it actually makes it work better. It loosens and thins the mucus in your chest so your cough can move it out of your airways more effectiv...
  • What exactly does guaifenesin do — does it actually stop my cough?
  • No — extended-release tablets like 12 Hour Mucus Relief and 365 Whole Foods Market Guaifenesin must be swallowed whole. Crushing, chewing, or breaking them releases the medicine al...
  • Can I crush or split the extended-release tablet to make it easier to swallow?
📖 Read our full Guaifenesin guide →
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 $0.023 $2.70 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0908 $10.71 / 118 ml
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
Oct 2022 Feb 2024 Apr 2026 Sep 2026 $0.023 $0.013
▲ Up 53% over the last 15 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54859-0507-04 You're viewing this Main listing 118 mL in 1 BOTTLE 2019-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chest Congestion Relief 100 mg/5mL 00536-1314-85 RUGBY 473 ml $0.011 — Availability likely save 52%
Guaifenesin 100 mg/5mL 58657-0508-16 Method 473 ml $0.011 — Availability likely save 52%
Guaifenesin 100 mg/5mL 83720-0503-16 Oncor 473 ml $0.011 — Availability likely save 52%
Guaifenesin 100 mg/5mL 58657-0509-16 Method 473 ml $0.013 — FDA listed save 42%
Good Neighbor Adult Tussin Mucus and chest congestion 200 mg/10mL 46122-0785-29 AMERISOURCE 1 bottle $0.023 — Availability likely —
Tusnel EX 100 mg/5mLthis 54859-0507-04 Llorens 118 ml $0.023 — Availability likely —
Mucolyte 100 mg/5mL 57237-0359-12 Rising 118 ml $0.023 — Availability likely —
Tussin 200 mg/10mL 70677-1186-01 Strategic 1 bottle $0.023 — Availability likely —
Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 82568-0012-04 AARNA 1 bottle $0.023 — Availability likely —
QCH Adult Tussin 541 200 mg/10mL 83324-0024-04 Chain 1 bottle $0.023 — Availability likely —
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor 400 mg/20mL 63824-0537-66 Reckitt 180 ml $0.061 — FDA listed +164%
Guaifenesin 100 mg/5mL 00121-0744-04 PAI 118 ml — — FDA listed —
Guaifenesin 200 mg/10mL 00121-1488-00 PAI 10 cups — — FDA listed —
Guaifenesin 100 mg/5mL 00121-1744-00 PAI 10 cups — — FDA listed —
Guaifenesin 300 mg/15mL 00121-2232-00 PAI 10 cups — — FDA listed —
Walgreen Cherry 200 mg/10mL 00363-7043-08 WALGREEN 1 bottle — — FDA listed —
Childrens Chest Congestion Relief 100 mg/5mL 00363-7504-04 WALGREENS 1 bottle — — FDA listed —
Tusnel EX 100 mg/5mL 50090-6542-00 A-S 118 ml — — FDA listed —
CVS Adult Mucus plus Chest Congestion 200 mg/10mL 51316-0437-08 CVS 1 bottle — — FDA listed —
CVS Adult Mucus chest congestion 200 mg/10mL 51316-0743-08 CVS 1 bottle — — FDA listed —
Tussin 100 mg/5mL 53943-0507-26 Discount 237 ml — — FDA listed —
Childrens Chest Congestion Relief Grape 100 mg/5mL 53943-0511-24 Discount 118 ml — — FDA listed —
Llorens Care Tussin 100 mg/5mL 54859-0510-16 Llorens 473 ml — — FDA listed —
Guaifenesin 200 mg/10mL 55154-5780-05 Cardinal 5 cups — — FDA listed —
Guaifenesin 100 mg/5mL 55154-9450-05 Cardinal 5 cups — — FDA listed —
Geri-Tussin 200 mg/10mL 57896-0293-16 Geri-Care 473 ml — — FDA listed —
Geri-Tussin 100 mg/5mL 57896-0693-16 Geri-Care 473 ml — — FDA listed —
Cough Out 100 mg/5mL 58593-0255-04 Efficient 118 ml — — Discontinued —
Rompe Pecho SF 100 mg/5mL 58593-0265-04 Efficient 118 ml — — Discontinued —
Rompe Pecho EX 200 mg/10mL 58593-0829-04 Efficient 118 ml — — FDA listed —
Guaifenesin 100 mg/5mL 60687-0852-17 American 10 cups — — FDA listed —
Guaifenesin 200 mg/10mL 60687-0863-56 American 10 cups — — FDA listed —
Guaifenesin 300 mg/15mL 60687-0874-16 American 10 cups — — FDA listed —
Childrens Mucus Relief Chest Congestion 100 mg/5mL 63868-0770-04 Chain 1 bottle — — FDA listed —
SDA Laboratories Tussin 100 mg/5mL 66424-0563-16 SDA 473 ml — — FDA listed —
DRx Choice Fruit Punch 200 mg/10mL 68163-0743-04 Raritan 1 bottle — — FDA listed —
Adult Tussin 200 mg/10mL 69230-0332-23 Camber 1 bottle — — FDA listed —
Reliable-1 Tussin 100 mg/5mL 69618-0068-54 RELIABLE 118 ml — — FDA listed —
Akin 100 mg/5mL 69822-0200-02 Southern 118 ml — — FDA listed —
MAX Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 71399-0024-04 Akron 1 bottle — — FDA listed —
MAX Tussin Mucus and Chest Congestion 200 mg/10mL 71399-0054-08 Akron 1 bottle — — FDA listed —
Guaifenesin STRAWBERRY-BANANA FLAVOR 100 mg/5mL 71800-0059-19 Innovida 119 ml — — FDA listed —
Guaifenesin 100 mg/5mL 72162-2278-02 Bryant 473 ml — — FDA listed —
Guaifed 200 mg/10mL 73564-0801-04 Aldama 118 ml — — FDA listed —
Tussin Expectorant 100 mg/5mL 76281-0507-24 AptaPharma, 118 ml — — FDA listed —
Meijer Adult Mucus Plus chest congestion 200 mg/10mL 79481-7430-08 MEIJER 1 bottle — — FDA listed —
Guaifenesin 100 mg/5mL 81033-0102-51 KESIN 50 cups — — FDA listed —
Quality Choice Adult Tussin Expectorant 200 mg/10mL 83324-0332-04 QUALITY 1 bottle — — FDA listed —
Curewell Tussin 100 mg/5mL 85111-0693-16 RMT 473 ml — — 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

🏛️
2019
On the market since
May 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.

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.

🧪 Avoiding an ingredient? See Guaifenesin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 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 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 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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 statesInactive ingredients  anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a 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 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

LabelerLlorens Pharmaceutical International Division, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedMay 2019
Product typeHuman Otc Drug
Portfolio12 products on file

More NDCs from Llorens Pharmaceutical International Division, I... labeler code 54859

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

⏱️ Dosage and Administration 36 words ▾

Directions: Do not exceed more than 6 doses in any 24-hour period. Age Dose Adults and children over 12 years and over 2 teaspoonfuls (10 mL) every 4 hours Children under 12 years Ask a doctor

⚠️ Warnings 123 words ▾

Warnings Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for 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 8 words ▾

In each 5 mL Guaifenesin - 100 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a sucralose.

🎯 Purpose 2 words ▾

Purpose Expectorant

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeing, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-8660595-5598

📄 Package Label / Principal Display Panel 1 words ▾

TusnelEX

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5K
Units reimbursed last 4 qtrs
875.5K
Gross reimbursed last 4 qtrs
$79.5K
Avg / prescription
$15.97
Avg / unit
$0.0908
Latest quarter Q1 2026
991Rx
Medicaid pays / mL
$0.0908
gross reimbursed
vs
NADAC / mL
$0.0229
acquisition cost
=
Spread
+$0.0679
+297% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
80% FFS 20% MCO
Fee-for-service · 3,972 Rx Managed care · 1,003 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 15,597 units · 272 per 100k residents MN Wisconsin: 126,699 units · 2,144 per 100k residents WI Michigan: 37,882 units · 377 per 100k residents MI New York: 312,500 units · 1,597 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 4,878 units · 71.1 per 100k residents IN Ohio: 3,106 units · 26.4 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 27,318 units · 294 per 100k residents NJ Massachusetts: no data reported MA California: 251,859 units · 646 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 5,874 units · 130 per 100k residents KY West Virginia: no data reported WV Virginia: 19,178 units · 220 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3,894 units · 52.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 23,996 units · 337 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 42,691 units · 1,452 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
26.42,144
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 2,144 /100k
2 New York 1,597 /100k
3 Mississippi 1,452 /100k
4 California 646 /100k
5 Michigan 377 /100k
6 Tennessee 337 /100k
7 New Jersey 294 /100k
8 Minnesota 272 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 54859-0506-04 · Llorens 54859-0508-16 · LLORENS →
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.