Leader Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin 20 mg; 400 mg Tablet, 60-count
by Cardinal Health · 1 BOTTLE in 1 CARTON (70000-0056-1) / 60 TABLET in 1 BOTTLE
NDC 70000-0056-01
🏷️ FDA NDC (as labeled)
70000-0056-1
billing pads the package 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)
70000-0056-1
Product NDC
70000-0056
11-digit billing NDC
70000005601
NCPDP billing unit
EA — each (per item)
RxCUI
1147685
UNII
9D2RTI9KYH, 495W7451VQ
UPC
0096295140088
Application #
M012
SPL Set ID
8397e1b9-e83e-4c6a-b858-1663c2365840
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
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
GPI-14
43997002520345
GPI class
Chest Congestion Relief DM
GCN Seq No
058386
GCN
23807
HICL code
000223
Ingredient (HICL)
Guaifenesin/Dextromethorphan
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
B3T
Therapeutic class — specific (HIC3)
Non-Opioid Antitussive And Expectorant Combination
AHFS code
48:08.00.00
AHFS class
Antitussives
FDB label name
CHEST CONG RLF DM 400-20 MG TB
FDB brand name
Chest Congestion Relief Dm
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0056-1 — 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 → 70000-0056-01. 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
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 CONG RLF DM 400-20 MG TB Ingredient Guaifenesin/Dextromethorphan
📖 What it is MedlinePlus · NLM
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- The two ingredients tackle your symptoms from different angles. Guaifenesin is an expectorant — it helps thin and loosen the mucus in your chest so you can cough it up more easily....
- What exactly does this combination do — why are two ingredients needed?
- It depends on which antidepressant you're taking. If it's a type called an MAOI — which includes certain older antidepressants and some medications for Parkinson's disease — you sh...
- Can I take this if I'm on an antidepressant?
Patient education
Supplement & herbal interactions
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 Dextromethorphan Hydrobromide / Guaifenesin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeOval
ImprintPH073
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
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 statesInactive Ingredients magnesium 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 | $0.080 | $4.77 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3391 | $20.35 / 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 7% 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 DM DM 20 mg/1; 400 mg 63868-0753-50 | Chain | 50 tablets | $0.074 | — | FDA listed | save 7% |
| Rugby Chest Congestion Relief DM 20 mg/1; 400 mg 00536-1312-08 | Rugby | 60 tablets | $0.079 | — | Availability likely | — |
| Good Neighbor Pharmacy Mucus Relief DM 20 mg/1; 400 mg 24385-0026-71 | AmerisourceBergen | 50 tablets | $0.079 | — | Availability likely | — |
| Mucus Relief DM Cough 20 mg/1; 400 mg 46122-0790-61 | Amerisource | 50 tablets | $0.079 | — | Availability likely | — |
| Leader Chest Congestion Relief DM 20 mg/1; 400 mgthis 70000-0056-01 | Cardinal | 60 tablets | $0.079 | — | Availability likely | — |
| Mucus Relief DM Cough Maximum Strength 20 mg/1; 400 mg 70000-0278-01 | Cardinal | 12 tablets | $0.079 | — | Availability likely | — |
| Foster and Thrive Chest Congestion Relief DM DM 20 mg/1; 400 mg 70677-1055-01 | Strategic | 50 tablets | $0.079 | — | Availability likely | — |
| Quality Choice Mucus Relief DM DM 20 mg/1; 400 mg 83324-0195-50 | Chain | 50 tablets | $0.079 | — | Availability likely | — |
| Sunmark Chest Congestion Relief DM DM 20 mg/1; 400 mg 49348-0728-09 | Strategic | 50 tablets | $0.080 | — | Availability likely | +0% |
| Mucus Relief DM 20 mg/1; 400 mg 00363-0533-01 | Walgreen | 30 tablets | — | — | FDA listed | — |
| Refenesen Mucus Relief DM 20 mg/1; 400 mg 10956-0846-30 | Reese | 30 tablets | — | — | FDA listed | — |
| Pharbinex-Dm 400 mg/1; 20 mg 16103-0381-04 | Pharbest | 30 tablets | — | — | FDA listed | — |
| Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 17714-0150-60 | Advance | 60 tablets | — | — | FDA listed | — |
| Kroger Chest Congestion Relief DM 20 mg/1; 400 mg 30142-0472-30 | THE | 30 tablets | — | — | FDA listed | — |
| TopCare Chest Congestion and Cough Relief DM 20 mg/1; 400 mg 36800-0988-50 | TOPCO | 30 tablets | — | — | FDA listed | — |
| Mucus Relief Dm 20 mg/1; 400 mg 37835-0403-40 | Bi-Mart | 40 tablets | — | — | FDA listed | — |
| Equaline Chest Congestion Relief DM DM 20 mg/1; 400 mg 41163-0114-50 | United | 50 tablets | — | — | FDA listed | — |
| Mucus Relief Dm 20 mg/1; 400 mg 41226-0280-03 | KROGER | 30 tablets | — | — | FDA listed | — |
| Mucus Relief DM 20 mg/1; 400 mg 41250-0533-11 | Meijer | 60 tablets | — | — | FDA listed | — |
| Guaifenesin DM 400 mg/1; 20 mg 43063-0801-60 | PD-Rx | 60 tablets | — | — | FDA listed | — |
| Medique Medi-Mucus 20 mg/1; 400 mg 47682-0432-46 | Unifirst | 1 tablet | — | — | FDA listed | — |
| Mucosa Dm 400 mg/1; 20 mg 49483-0280-00 | TIME | 100000 tablets | — | — | FDA listed | — |
| Mucus Relief DM Immediate Release 20 mg/1; 400 mg 50804-0432-30 | Good | 30 tablets | — | — | FDA listed | — |
| Mucus Relief DM 20 mg/1; 400 mg 50804-0858-30 | Good | 30 tablets | — | — | Discontinued | — |
| Mucus Relief DM Cough 20 mg/1; 400 mg 50844-0633-11 | L.N.K. | 60 tablets | — | — | FDA listed | — |
| Mucosa DM 20 mg/1; 400 mg 54257-0277-01 | Magno-Humphries, | 50 tablets | — | — | FDA listed | — |
| Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 54738-0985-30 | Richmond | 30 tablets | — | — | FDA listed | — |
| Mucus Relief DM 20 mg/1; 400 mg 55301-0533-01 | ARMY | 10 tablets | — | — | FDA listed | — |
| Family Wellness Chest Congestion Relief DM DM 20 mg/1; 400 mg 55319-0890-30 | Family | 30 tablets | — | — | FDA listed | — |
| Dollar General Chest Congestion Relief DM 20 mg/1; 400 mg 55910-0272-30 | Dolgencorp, | 30 tablets | — | — | FDA listed | — |
| Chest Congestion Relief DM 20 mg/1; 400 mg 55910-0533-01 | DOLGENCORP, | 30 tablets | — | — | FDA listed | — |
| Guaifenesin and Dextromethorphan Hydrobromide 400 mg/1; 20 mg 57631-0013-10 | InvaTech | 26500 tablets | — | — | FDA listed | — |
| Mucus Relief Xpect 400 mg/1; 20 mg 63654-0342-20 | Selder, | 20 tablets | — | — | FDA listed | — |
| Always Save Chest Congestion Relief DM 20 mg/1; 400 mg 63941-0985-50 | Valu | 50 tablets | — | — | FDA listed | — |
| Marcs Chest Congestion Relief DM 20 mg/1; 400 mg 68998-0114-50 | Marc | 50 tablets | — | — | FDA listed | — |
| Mucus Relief DM Immediate Release 20 mg/1; 400 mg 69168-0432-07 | Allegiant | 10 tablets | — | — | FDA listed | — |
| CVS Chest Congestion Relief DM 20 mg/1; 400 mg 69842-0996-30 | CVS | 30 tablets | — | — | FDA listed | — |
| RIGHT REMEDIES Mucus Relief DM 20 mg/1; 400 mg 70692-0181-25 | Strive | 250 tablets | — | — | FDA listed | — |
| Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 71335-1928-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Rugby Chest Congestion Relief DM 20 mg/1; 400 mg 71335-2216-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Mucus Relief DM 20 mg/1; 400 mg 72090-0027-01 | Pioneer | 150 tablets | — | — | FDA listed | — |
| Care One Chest Congestion Relief DM 20 mg/1; 400 mg 72476-0871-50 | RETAIL | 50 tablets | — | — | FDA listed | — |
| Pharbinex-DM 400 mg/1; 20 mg 73057-0381-04 | Ulai | 30 tablets | — | — | FDA listed | — |
| Mucus Relief Xpect 400 mg/1; 20 mg 76095-0012-20 | Midway | 20 tablets | — | — | FDA listed | — |
| Mucus Relief DM 20 mg/1; 400 mg 76162-0008-01 | TopCo | 100 tablets | — | — | FDA listed | — |
| Mucus DM 20 mg/1; 400 mg 79481-5330-01 | Meijer | 60 tablets | — | — | FDA listed | — |
| Mucus Relief Dm 20 mg/1; 400 mg 80513-0407-09 | Advanced | 90 tablets | — | — | FDA listed | — |
| Mucus Relief DM 20 mg/1; 400 mg 84324-0035-01 | NUVICARE | 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
🔒
·
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.
🗺️ 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 70000-0056-01, 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
279
Units reimbursed last 4 qtrs
9.8K
Gross reimbursed last 4 qtrs
$3.3K
Avg / prescription
$11.94
Avg / unit
$0.3391
Latest quarter Q4 2025
73Rx
Medicaid pays / ea
$0.3391
gross reimbursed
vs
NADAC / ea
$0.0795
acquisition cost
=
Spread
+$0.2596
+327% 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 · 279 Rx Managed care · 0 Rx
State Medicaid map
Units reimbursed · per 100k residents
1.347.7
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 Leader Chest Congestion Relief DM (this brand).
Top reported reactions
Reporter sex
Male · 100%
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 |
|---|---|---|---|
| 70000-0056-01 You're viewing this | 1 BOTTLE in 1 CARTON (70000-0056-1) / 60 TABLET in 1 BOTTLE | 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 ■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ 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 Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.
📦 Storage and Handling ▾
Other Information Store at 15°-30°C (59°-86°F)
🧪 Active Ingredient ▾
Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg 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. image of display
🎯 Purpose ▾
Purpose Cough Suppressant 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.