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Mucus Relief Immediate Release Guaifenesin 400mg 400 mg Tablet, 100-count

by TopCo Associates, LLC · 100 TABLET in 1 BOTTLE (76162-004-01)
NDC 76162-0004-01
🏷️ FDA NDC (as labeled) 76162-004-01 billing pads the product 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 76162-004-01
Product NDC 76162-004
11-digit billing NDC 76162000401
RxCUI 359601
UNII 495W7451VQ
Application # M012
SPL Set ID 7d91c6ab-d161-42b9-b353-0aa8f59619f8
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 2014-12-23
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN
Why two NDCs? The FDA registers this code as 76162-004-01 — 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 → 76162-0004-01. 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

LabelerTopCo Associates, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio58 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

📗 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 →

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.

🧪 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.

💲 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 eachPer 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.
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
Quality Choice Mucus Relief 400 mg 63868-0998-50 Chain 50 tablets $0.063 — FDA listed —
Rugby Chest Congestion Relief G450 400 mg 00536-1311-08 Rugby 60 tablets $0.066 — Availability likely —
Good Neighbor Pharmacy Mucus Relief 400 mg 24385-0602-65 AmerisourceBergen 30 tablets $0.066 — Availability likely —
Guaifenesin 400 mg 24689-0144-01 APNAR 100 tablets $0.066 — Availability likely —
Mucus Relief 400 mg 46122-0794-61 Amerisource 50 tablets $0.066 — Availability likely —
Leader Chest Congestion Relief G450 400 mg 70000-0055-01 Cardinal 60 tablets $0.066 — Availability likely —
Foster and Thrive Chest Congestion Relief 400 mg 70677-1054-01 Strategic 50 tablets $0.066 — Availability likely —
HealthMart Chest Congestion Relief 400 mg 62011-0060-01 Strategic 50 tablets $0.066 — FDA listed —
Chest Congestion Relief 400 mg 49348-0729-09 Strategic 24 tablets $0.067 — Availability likely —
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 mgthis 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 —
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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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 Guaifenesin 400mg — the ingredient across all brands.

Top reported reactions

Fatigue27
Covid-1924
Pneumonia24
Dyspnoea22
Fall22
Pain20
Diarrhoea19

Age at onset

Adolescent1
Adult31
Elderly37

Reporter sex

359 reports
Male · 41%
Female · 59%

Serious outcomes

Hospitalization85
Death26
Disabling6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 68 0
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 NDCDescription Marketing startStatus
76162-0004-01 You're viewing this 100 TABLET in 1 BOTTLE (76162-004-01) 2014-12-23 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 "Otc Monograph Drug". 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 FDA registers it as 76162-004-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76162-0004-01, written without dashes as 76162000401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76162-0004-01, the first segment (76162) is the labeler code FDA assigned to TopCo Associates, LLC; the middle segment (0004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by TopCo Associates, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TopCo Associates, LLC 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.

📄 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 21 words ▾

Use(s) helps loosen phlegm (mucus)and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

⏱️ Dosage and Administration 40 words ▾

Directions Adults and children12 years of age and older Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under12 years of age: do not use

⚠️ Warnings 108 words ▾

Warnings Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage do not use for more than 7 days Stop use and ask a doctor if cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Pregnancy/Breastfeeding ask a healthcare professional before use.

Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 24 words ▾

Storage store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F) keep in a dry place and do not expose to heat

🧪 Active Ingredient 5 words ▾

Active ingredient(s) Guaifenesin 400 mg

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

🎯 Purpose 2 words ▾

Purpose Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76162-0002-58 · TopCo 76162-0005-98 · TopCo →
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.