Home › NDC Lookup › Ingredients › Guaifenesin › 53041-0190-20
Mucus Relief 600 mg Guaifenesin 600 mg Tablet, Extended Release, 500-count — NDC 53041-0190-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mucus Relief 600 mg Guaifenesin 600 mg Tablet, Extended Release, 500-count — NDC 53041-190-20 (Billing 53041-0190-20)

by Guardian Drug Company · 500 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 500 tablets of Mucus Relief 600 mg Guaifenesin 600 mg Tablet, Extended Release from Guardian Drug Company, marketed since Jun 2020 and currently FDA-listed.

NDC 53041-0190-20
🏷️ FDA NDC (as labeled) 53041-190-20 billing pads the product segment with a zero
This package
Contains500-count Pack sizes4 compare ↓
Product page 53041-0190-16 Also comes in: 10 tablets 53041-190-32 10 tablets 53041-190-38 100 tablets 53041-190-16
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53041-190-20
Product NDC 53041-190
11-digit billing NDC 53041019020
RxCUI 310621, 636522
UNII 495W7451VQ
Application # ANDA209215
SPL Set ID e7742a43-9066-4e28-a90d-f07c0e18f045
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-24
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 310621
Why two NDCs? The FDA registers this code as 53041-190-20 — 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 → 53041-0190-20. 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

📗 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 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.
Try another pack size: 10 tablets 10 tablets 100 tablets
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
53041-0190-16 53041-190-16 Main listing 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 2020-06-24 — Active
53041-0190-20 You're viewing this 500 TABLET, EXTENDED RELEASE in 1 BOTTLE 2020-06-24 — Active
53041-0190-32 53041-190-32 2 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2020-06-24 — Active
53041-0190-38 53041-190-38 4 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2020-06-24 — Active

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, extended release in 1 bottle.
How does this package differ from NDC 53041-0190-16?
Both are Mucus Relief 600 mg Guaifenesin 600 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 500-count one, while NDC 53041-0190-16 is the 100 tablets package.
What NDC number is used to bill for this package of Mucus Relief 600 mg Guaifenesin 600 mg Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense mucus er 600 mg 00113-2023-60 L. 20 tablets $0.284 — Availability likely —
Mucus Relief Extended Release 600 mg 00536-1163-61 Rugby 100 tablets $0.284 — Availability likely —
Mucus Relief ER 600 mg 00904-6718-39 Major 100 tablets $0.284 — Availability likely —
Mucus Relief 600 mg 00904-6986-40 Major 500 tablets $0.284 — Availability likely —
Guaifenesin 600 mg 46122-0750-51 AMERISOURCE 10 tablets $0.284 — Availability likely —
Guaifenesin 600 mg 51660-0566-21 Ohm 20 tablets $0.284 — Availability likely —
Mucus Relief 600 mg 63739-0067-02 McKesson 10 tablets $0.284 — Availability likely —
Guaifenesin Extended-Release 600 mg 68094-0048-61 Precision 10 tablets $0.284 — Availability likely —
Leader Mucus Relief 600 mg 70000-0758-01 Cardinal 20 tablets $0.284 — Availability likely —
Guaifenesin 600 mg 70010-0199-05 GRANULES 500 tablets $0.284 — Availability likely —
Foster and Thrive Mucus Relief 600 mg 70677-1013-01 Strategic 10 tablets $0.284 — Availability likely —
Mucus Relief 600 mg 70677-1052-01 Strategic 1 tablet $0.284 — Availability likely —
Guaifenesin 600 mg 70677-1257-01 Strategic 20 tablets $0.284 — Availability likely —
foster and thrive mucus relief 600 mg 70677-1291-01 Strategic 20 tablets $0.284 — Availability likely —
Mucus Relief 600 mg 83324-0097-20 CHAIN 20 tablets $0.284 — Availability likely —
Guaifenesin 600 mg 68001-0561-17 BluePoint 10 tablets $0.325 — FDA listed —
Mucinex 600 mg 63824-0008-15 Reckitt 20 tablets $0.543 — FDA listed —
Mucinex 600 mg 68084-0572-01 American 1 tablet $0.543 — FDA listed —
Guaifenesin 600 mg 00363-0028-96 WALGREEN 20 tablets — — FDA listed —
Mucus Relief Extended Release 600 mg 00363-0931-10 Walgreens 100 tablets — — Discontinued —
Guaifenesin 600 mg 00363-9569-02 Walgreens 20 tablets — — FDA listed —
Rugby Mucus Relief Er 600 mg 00536-1489-20 Rugby 20 tablets — — FDA listed —
Mucus Relief 600 mg 00615-8637-39 NCS 30 tablets — — FDA listed —
up and up mucus relief 600 mg 11673-0421-60 Target 20 tablets — — Discontinued —
Guaifenesin 600 mg 11673-0539-02 TARGET 20 tablets — — FDA listed —
Mucus Relief Extended-Release 600 mg 11673-0731-20 TARGET 20 tablets — — Discontinued —
mucus relief 600 mg 11822-2123-01 Rite 20 tablets — — Discontinued —
Mucus Relief 600 mg 11822-3252-07 Rite 40 tablets — — FDA listed —
Mucinex 600 mg 17856-0008-02 ATLANTIC 1 tablet — — FDA listed —
Guaifenesin 600 mg 21130-0179-67 Better 20 tablets — — FDA listed —
Guaifenesin 600 mg 25000-0042-01 MARKSANS 20 tablets — — FDA listed —
Guaifenesin 600 mg 30142-0961-20 Kroger 20 tablets — — FDA listed —
Mucus Relief 600 mg 36800-0137-20 TOP 20 tablets — — Discontinued —
Topco Mucus Relief 600 mg 36800-0226-16 Topco 100 tablets — — FDA listed —
Mucus Relief 600 mg 37808-0830-20 H 20 tablets — — FDA listed —
Mucus Relief 600 mg 37808-0935-40 H 40 tablets — — FDA listed —
Mucus Relief 600 mg 37835-0408-40 Bi-Mart 40 tablets — — FDA listed —
Mucus Relief 600 mg 41163-0731-20 United 20 tablets — — FDA listed —
Mucus Relief 600 mg 41226-0723-02 KROGER 20 tablets — — FDA listed —
mucus relief 600 mg 41250-0684-02 Meijer 20 tablets — — FDA listed —
Guaifenesin 600 mg 41415-0996-20 Publix 20 tablets — — FDA listed —
Mucus Relief Extended Release 600 mg 41520-0731-20 Care 20 tablets — — FDA listed —
mucus er 600 mg 42507-0202-60 HyVee 20 tablets — — FDA listed —
Mucus Relief 600 mg 42507-0253-03 HYVEE 20 tablets — — FDA listed —
365 Whole Foods Market Guaifenesin 600 mg 42681-0057-01 Whole 20 tablets — — FDA listed —
Guaifenesin 600 mg 43598-0008-40 Dr. 20 tablets — — FDA listed —
Guaifenesin 600 mg 43598-0110-01 Dr. 20 tablets — — FDA listed —
Guaifenesin Extended Release 600 mg 49483-0723-50 TIME 500 tablets — — FDA listed —
Mucinex 600 mg 50090-0818-00 A-S 20 tablets — — FDA listed —
Mucinex 600 mg 50090-1340-00 A-S 20 tablets — — FDA listed —
Mucinex 600 mg 50090-2380-00 A-S 28 tablets — — FDA listed —
Mucinex 600 mg 50090-6078-00 A-S 480 tablets — — FDA listed —
Guaifenesin 600 mg 51316-0008-01 CVS 20 tablets — — FDA listed —
Guaifenesin 600 mg 51316-0071-68 CVS 68 tablets — — FDA listed —
Mucus And Chest Congestion 600 mg 51316-0299-01 CVS 20 tablets — — FDA listed —
Mucus Relief 600 mg 51316-0470-01 CVS 20 tablets — — FDA listed —
Mucus Relief 600 mgthis 53041-0190-20 Guardian 500 tablets — — FDA listed —
Guaifenesin Extended-Release 600 mg 53041-0233-30 Guardian 10 tablets — — FDA listed —
Mucus Relief 600 mg 53942-0203-02 Demoulas 20 tablets — — FDA listed —
Mucus Relief 600 mg 53943-0233-32 Discount 10 tablets — — FDA listed —
Mucus Relief ER 600 mg 55154-4153-00 Cardinal 10 tablets — — FDA listed —
Mucinex 600 mg 55154-4680-00 Cardinal 1 tablet — — FDA listed —
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg 55681-0301-01 TWIN 100 tablets — — FDA listed —
Mucus Relief 600 mg 55910-0739-20 Dolgencorp, 20 tablets — — FDA listed —
DG Health Mucus ER 600 mg 55910-0904-01 Dolgencorp, 20 tablets — — FDA listed —
Mucus Relief 600 mg 57344-0203-02 AAA 10 tablets — — FDA listed —
Crcle Guaifenesin Extended-Release Tablets, 600 mg 57483-0270-01 Innovus 100 tablets — — FDA listed —
Giltuss EX Expectorant 600 mg 58552-0338-07 Gil 7 tablets — — FDA listed —
Giltuss Diabetic Ex 600 mg 58552-0339-07 Gil 7 tablets — — FDA listed —
Giltuss HBP EX Expectorant 600 mg 58552-0340-07 Gil 7 tablets — — FDA listed —
Guaifenesin 600 mg 58602-0810-12 Aurohealth 40 tablets — — FDA listed —
Guaifenesin 600 mg 58602-0853-12 Aurohealth 40 tablets — — FDA listed —
Guaifenesin 600 mg 58602-0864-98 Aurohealth 20 tablets — — FDA listed —
Mucus Relief 600 mg 59726-0734-20 P 1 tablet — — FDA listed —
Guaifenesin 600 mg 62207-0570-30 Granules 20000 tablets — — FDA listed —
Guaifenesin 600 mg 62207-0839-72 Granules 10 tablets — — FDA listed —
Mucinex 600 mg 63187-0954-20 Proficient 20 tablets — — FDA listed —
Mucinex 600 mg 63629-7115-01 Bryant 30 tablets — — FDA listed —
Mucinex 600 mg 63629-7886-01 Bryant 20 tablets — — FDA listed —
12 Hour Mucus Relief 600 mg 63868-0149-20 CHAIN 10 tablets — — FDA listed —
Mucus Relief 600 mg 63941-0731-20 Best 20 tablets — — FDA listed —
Guaifenesin 600 mg 65162-0036-02 Amneal 10 tablets — — FDA listed —
Mucus Relief 600 mg 67091-0370-20 WinCo 20 tablets — — FDA listed —
Mucus Relief 600 mg 67091-0403-02 WINCO 10 tablets — — FDA listed —
Mucus Relief Extended Release 600 mg 67296-1467-07 Redpharm 1 tablet — — FDA listed —
good sense mucus er 600 mg 67296-2223-02 Redpharm 20 tablets — — FDA listed —
Mucinex 600 mg 67544-0149-53 Aphena 60 tablets — — FDA listed —
Mucus Relief 600 mg 69168-0459-02 Allegiant 150 tablets — — FDA listed —
Mucus Relief 600 mg 69256-0731-20 Harris 1 tablet — — FDA listed —
mucus 600 mg 69842-0806-01 CVS 20 tablets — — FDA listed —
Guaifenesin 600 mg 69848-0017-02 GRANULES 20 tablets — — FDA listed —
Mucus Relief 600 mg 71335-2642-01 Bryant 30 tablets — — FDA listed —
Mucus Relief 600 mg 71610-0499-12 Aphena 12 tablets — — FDA listed —
Mucus Relief 600 mg 72036-0203-02 HARRIS 20 tablets — — FDA listed —
Mucus Relief 600 mg 72090-0011-01 Pioneer 200 tablets — — FDA listed —
basic care mucus er 600 mg 72288-0298-02 Amazon.com 20 tablets — — FDA listed —
Curist Mucus Relief 600 mg 72559-0017-22 Little 200 tablets — — FDA listed —
Guaifenesin 600 mg 73581-0400-02 YYBA 200 tablets — — FDA listed —
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg 73581-0401-02 YYBA 200 tablets — — FDA listed —
Topcare mucus er 600 mg 76162-0123-58 Topco 40 tablets — — FDA listed —
Guaifenesin 600 mg 79903-0124-20 Walmart 20 tablets — — FDA listed —
Guaifenesin Extended Release 600 mg 79903-0271-40 Wal-Mart 20 tablets — — FDA listed —
equate mucus-er 600 mg 79903-0292-12 WALMART 40 tablets — — FDA listed —
Mucus Relief 600 mg 80513-0403-20 Advanced 200 tablets — — FDA listed —
Mucus Relief 600 mg 81522-0203-02 FSA 20 tablets — — FDA listed —
Guaifenesin 600 mg 82804-0265-20 Proficient 20 tablets — — FDA listed —
Mucus Relief 600 mg 84324-0026-01 NUVICARE 40 tablets — — FDA listed —
Dr. Simi Mucus Relief 600 mg 85786-0302-40 Farmacias 20 tablets — — FDA listed —
Mucus Relief 600 mg 85828-0723-02 Grocery 20 tablets — — FDA listed —
Guaifenesin 600 mg 87448-1701-02 Northwestern 1 tablet — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color White
ShapeCapsule
ImprintG234
Size22 mm
ScoringNot scored
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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.

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

The official label also statescarbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

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

LabelerGuardian Drug Company
Application holderGUARDIAN DRUG CO
FDA applicationANDA209215 (ANDA)
Labeler code53041
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio46 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

USE(S) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 58 words ▾

DIRECTIONS do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings 2 words ▾

WARNING .

📦 Storage and Handling 29 words ▾

OTHER INFORMATION tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store between 20 to 25°C (68 to 77°F)

🧪 Active Ingredient 8 words ▾

ACTIVE INGREDIENT(in each extended-release tablet) Guaifenesin 1200 mg

🧪 Inactive Ingredients 8 words ▾

INACTIVE INGREDIENTS carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

🎯 Purpose 2 words ▾

PURPOSE Expectorant

📄 Do Not Use 10 words ▾

DO NOT USE for children under 12 years of age

📄 Ask a Doctor Before Use If 29 words ▾

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 too much phlegm (mucus)

📄 Stop Use and Ask a Doctor If 31 words ▾

STOP USE AND A ASK DOCTOR IF cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

🤰 If Pregnant or Breast-Feeding 10 words ▾

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Package Label / Principal Display Panel 63 words ▾

PRINCIPAL DISPLAY PANEL NDC 53041-190-32 Compare to the active ingredient in Mucinex® Extended Release 600 mg Tablets GUARDIAN 12 HOUR Mucus Relief Guaifenesin Extended-Release Tablets 1200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 20 EXTENDED-RELEASE TABLETS NDC 53041-190-20 GUARDIAN 12 HOUR Mucus Relief Guaifenesin Extended-Release Tablets 1200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 500 EXTENDED-RELEASE TABLETS 23320 233500

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

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 Mucus Relief 600 mg (this brand).

Top reported reactions

Dyspnoea561
Pneumonia528
Nausea479
Fatigue450
Pain423
Diarrhoea402
Cough368

Age at onset

Neonate2
Infant2
Child20
Adolescent19
Adult530
Elderly535

Reporter sex

7,221 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Death919
Life-threatening332
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 468 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.

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 ✓ Available
Inactive ingredients (structured) ✓ 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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Guardian Drug Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 tablets (53041-0190-32), 10 tablets (53041-0190-38), 100 tablets (53041-0190-16). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Guardian Drug Company 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.
← 53041-0184-22 · Guardian 53041-0191-48 · Guardian →
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.