Leader Chest Congestion Relief G450 Guaifenesin 400 mg Tablet, 60-count
by Cardinal Health · 1 BOTTLE, PLASTIC in 1 CARTON (70000-0055-1) / 60 TABLET in 1 BOTTLE, PLASTIC
NDC 70000-0055-01
🏷️ FDA NDC (as labeled)
70000-0055-1
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 →
🆔 Identity & classification
FDA NDC (as labeled)
70000-0055-1
Product NDC
70000-0055
11-digit billing NDC
70000005501
NCPDP billing unit
EA — each (per item)
RxCUI
359601
UNII
495W7451VQ
UPC
0096295140095
Application #
M012
SPL Set ID
4586a83f-077c-4fb3-adfe-7a9497a78d97
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
2020-09-01
Route
ORAL
Dosage form
TABLET
Substance
GUAIFENESIN
GPI-14
43200010000340
GPI class
Chest Congestion Relief
GCN Seq No
051583
GCN
18906
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
CHEST CONGEST RLF 400 MG TAB
FDB brand name
Chest Congestion Relief
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0055-1 — 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 → 70000-0055-01. 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 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.
🏭 Manufacturer & labeler
LabelerCardinal Health
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio84 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 CHEST CONGEST RLF 400 MG TAB 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 is what's called an expectorant — it works to thin and loosen the mucus sitting in your chest and airways. That makes it easier to cough the mucus up and out, so instea...
- What exactly does guaifenesin do for my cough?
- Guaifenesin is meant for short-term use. If your cough isn't getting better after 7 days, keeps coming back, or shows up alongside a fever, rash, or a headache that won't go away,...
- How long can I take it before I should call my doctor?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Guaifenesin — tap one for details:
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.
💬 Questions about Guaifenesin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeOval
ImprintPH063
Size17 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesmagnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.
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.
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.065 | $3.92 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2750 | $16.50 / 60 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 1% over the last 24 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Quality Choice Mucus Relief 400 mg 63868-0998-50 | Chain | 50 tablets | $0.063 | — | FDA listed | save 3% |
| Rugby Chest Congestion Relief G450 400 mg 00536-1311-08 | Rugby | 60 tablets | $0.065 | — | Availability likely | — |
| Good Neighbor Pharmacy Mucus Relief 400 mg 24385-0602-65 | AmerisourceBergen | 30 tablets | $0.065 | — | Availability likely | — |
| Guaifenesin 400 mg 24689-0144-01 | APNAR | 100 tablets | $0.065 | — | Availability likely | — |
| Mucus Relief 400 mg 46122-0794-61 | Amerisource | 50 tablets | $0.065 | — | Availability likely | — |
| Leader Chest Congestion Relief G450 400 mgthis 70000-0055-01 | Cardinal | 60 tablets | $0.065 | — | Availability likely | — |
| Foster and Thrive Chest Congestion Relief 400 mg 70677-1054-01 | Strategic | 50 tablets | $0.065 | — | Availability likely | — |
| HealthMart Chest Congestion Relief 400 mg 62011-0060-01 | Strategic | 50 tablets | $0.066 | — | FDA listed | +1% |
| Chest Congestion Relief 400 mg 49348-0729-09 | Strategic | 24 tablets | $0.067 | — | Availability likely | +2% |
| Mucus Relief 400 mg 00363-0532-01 | Walgreen | 30 tablets | — | — | FDA listed | — |
| Guaifenesin 400mg 400 mg 10135-0790-30 | Marlex | 30 tablets | — | — | FDA listed | — |
| DG Health Immediate Release Mucus Relief 400 mg 10956-0059-30 | Reese | 30 tablets | — | — | FDA listed | — |
| Refenesen Mucus Relief 400 mg 10956-0845-30 | Reese | 30 tablets | — | — | FDA listed | — |
| Guaifenesin 400 mg 16103-0379-04 | Pharbest | 30 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 17714-0152-01 | Advance | 100 tablets | — | — | FDA listed | — |
| Kroger Mucus Relief 400 mg 30142-0471-30 | THE | 30 tablets | — | — | FDA listed | — |
| TopCare Chest Congestion Relief 400 mg 36800-0794-50 | TOPCO | 50 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 37835-0401-40 | Bi-Mart | 40 tablets | — | — | FDA listed | — |
| Equaline Chest Congestion Relief 400 mg 41163-0113-50 | United | 50 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 41226-0272-03 | KROGER | 30 tablets | — | — | FDA listed | — |
| Meijer Chest Congestion Relief 400 mg 41250-0713-50 | Meijer | 50 tablets | — | — | FDA listed | — |
| Mucosa 400 mg 49483-0272-00 | TIME | 100000 tablets | — | — | FDA listed | — |
| Mucus Relief Immediate Release 400 mg 50804-0371-30 | Good | 30 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 50804-0857-30 | Good | 30 tablets | — | — | Discontinued | — |
| Respiratory Relief 400 mg 53499-5295-00 | Schwabe | 30 tablets | — | — | FDA listed | — |
| Mucosa Guifenesin 400 mg 54257-0776-21 | Magno-Humphries, | 60 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 54738-0981-30 | Richmond | 30 tablets | — | — | FDA listed | — |
| Family Wellness Chest Congestion Relief 400 mg 55319-0891-30 | Family | 30 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 55681-0311-03 | TWIN | 300 tablets | — | — | FDA listed | — |
| Guaifenesin 400 400 mg 57631-0012-00 | InvaTech | 28000 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 57896-0714-01 | Geri-Care | 100 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 57896-0794-01 | Geri-Care | 100 tablets | — | — | FDA listed | — |
| Always Save Chest Congestion Relief GUAF 400 mg 63941-0987-50 | Valu | 50 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 66424-0001-01 | SDA | 100 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 68210-4158-01 | Prodose, | 15 tablets | — | — | FDA listed | — |
| Marcs Mucus Relief 400 mg 68998-0845-50 | Marc | 50 tablets | — | — | FDA listed | — |
| Mucus Relief Immediate Release 400 mg 69168-0370-01 | Allegiant | 100 tablets | — | — | FDA listed | — |
| Mucus Relief Immediate Release 400 mg 69168-0916-60 | Allegiant | 60 tablets | — | — | Discontinued | — |
| Mucus Relief 400 mg 69517-0005-02 | HealthLife | 200 tablets | — | — | Discontinued | — |
| Guaifenesin 400 mg 69618-0061-06 | Reliable | 60 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 71335-1035-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 71335-2032-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Guaifenesin 400 mg 71335-9616-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 71679-0119-02 | Health | 200 tablets | — | — | FDA listed | — |
| Guaifenesin 400 mg 71679-0309-00 | Health | 38500 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 72090-0009-02 | Pioneer | 300 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 72090-0013-01 | Pioneer | 200 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 72090-0019-01 | Pioneer | 200 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 72090-0035-01 | Pioneer | 200 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 72090-0044-01 | Pioneer | 200 tablets | — | — | FDA listed | — |
| Pharbinex 400 mg 73057-0379-04 | Ulai | 30 tablets | — | — | FDA listed | — |
| Mucus Relief Immediate Release 400 mg 76162-0004-01 | TopCo | 100 tablets | — | — | FDA listed | — |
| SIMPEX Guaifenesin 400 mg 76457-0004-00 | Simpex | 100 tablets | — | — | FDA listed | — |
| Guaifenesin 400Mg Caplets 400 mg 77333-0360-10 | Gendose | 100 tablets | — | — | FDA listed | — |
| Chest Congestion Relief 400 mg 79481-0714-05 | Meijer, | 50 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 82725-1012-01 | Cabinet | 200 tablets | — | — | FDA listed | — |
| Quality Choice Mucus Relief 400 mg 83324-0194-50 | Chain | 50 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 84324-0009-01 | NUVICARE | 100 tablets | — | — | FDA listed | — |
| Mucus Relief 400 mg 57896-0718-01 | Geri-Care | 100 tablets | — | — | 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
🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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.
🗺️ 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 70000-0055-01, 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 – Q4 2025 · 4 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
1.1K
Units reimbursed last 4 qtrs
52.2K
Gross reimbursed last 4 qtrs
$14.4K
Avg / prescription
$12.76
Avg / unit
$0.2750
Latest quarter Q4 2025
297Rx
Medicaid pays / ea
$0.2750
gross reimbursed
vs
NADAC / ea
$0.0653
acquisition cost
=
Spread
+$0.2097
+321% vs cost
What Medicaid paid per ea (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 ⓘ
Fee-for-service · 912 Rx Managed care · 214 Rx
State Medicaid map
Units reimbursed · per 100k residents
8.984.4
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
🔬 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 Guaifenesin — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 32%
Female · 67%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70000-0055-01 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (70000-0055-1) / 60 TABLET in 1 BOTTLE, PLASTIC | 2020-09-01 | 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
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make coughs more productive
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed Children under 6 years of age: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor
⚠️ Warnings ▾
Warnings Ask doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)
📦 Storage and Handling ▾
Other Information store at 15°-30°C (59°-86°F)
🧪 Active Ingredient ▾
Active ingredient (per tablet) Guaifenesin 400mg
🧪 Inactive Ingredients ▾
Inactive ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.
🎯 Purpose ▾
Purpose Expectorant
No label section mentions that — try another word, or open the full label on DailyMed below.
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.