Home › NDC Lookup › Ingredients › Guaifenesin And Pseudoephedrine Hcl › 58602-0834-78
Guaifenesin and Pseudoephedrine HCl 1200 mg; 120 mg Tablet, Extended Release — NDC 58602-0834-78 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guaifenesin and Pseudoephedrine HCl 1200 mg; 120 mg Tablet, Extended Release — NDC 58602-834-78 (Billing 58602-0834-78)

by Aurohealth LLC · 2 BLISTER PACK in 1 CARTON / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of Guaifenesin and Pseudoephedrine HCl 1200 mg; 120 mg Tablet, Extended Release from Aurohealth LLC, marketed since Mar 2020 and currently FDA-listed.

NDC 58602-0834-78
🏷️ FDA NDC (as labeled) 58602-834-78 billing pads the product segment with a zero
This package
Contains12 tablet, extended release in 1 blister pack Pack sizes2 compare ↓
Product page 58602-0834-77 Also comes in: 12 tablets 58602-834-77
OTC Generic 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 58602-834-78 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58602 labeler · 834 product · 78 package
Package marketed since
Mar 25, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5860283478 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-834-78
Product NDC 58602-834
11-digit billing NDC 58602083478
RxCUI 1244675
UNII 495W7451VQ, 6V9V2RYJ8N
Application # ANDA213203
SPL Set ID 2f622f57-4de0-44a9-a21f-c98260574f1e
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 2020-03-25
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1244675
Why two NDCs? The FDA registers this code as 58602-834-78 — 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 → 58602-0834-78. 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

📖 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
  • It helps loosen chest mucus so your cough is more productive. It also temporarily relieves nasal and sinus congestion from a cold, hay fever or other upper respiratory allergies.
  • Swallow them whole with a full glass of water. Don't crush, chew or break them. You can take them with or without food, and they're usually taken about every 12 hours. Follow the p...
  • How should I take the extended-release tablets?
  • Be careful here. If your medicine is an MAOI, you shouldn't take this product, or for 2 weeks after stopping the MAOI. If you aren't sure what your prescription is, ask me before y...
📖 Read our full Guaifenesin / Pseudoephedrine 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.

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: 12 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
58602-0834-77 58602-834-77 Main listing 1 BLISTER PACK in 1 CARTON / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2020-03-25 — Active
58602-0834-78 You're viewing this 2 BLISTER PACK in 1 CARTON / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2020-03-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 12 tablet, extended release in 1 blister pack.
What NDC number is used to bill for this package of Guaifenesin and Pseudoephedrine HCl 1200 mg; 120 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
Mucus D 1200 mg/1; 120 mg 00113-8911-62 L. 6 tablets $0.423 — Availability likely —
Leader Mucus Relief D 1200 mg/1; 120 mg 70000-0719-01 Cardinal 6 tablets $0.423 — Availability likely —
foster and thrive mucus relief d 1200 mg/1; 120 mg 70677-1273-01 Strategic 6 tablets $0.423 — Availability likely —
Mucinex D Maximum Strength 1200 mg/1; 120 mg 63824-0041-12 Reckitt 12 tablets $0.979 — Discontinued —
Guaifenesin and Pseudoephedrine HCl 1200 mg/1; 120 mg 00363-0134-78 WALGREEN 12 tablets — — FDA listed —
mucus relief d 1200 mg/1; 120 mg 00363-2389-62 Walgreen 6 tablets — — FDA listed —
Mucus Relief D 1200 mg/1; 120 mg 00363-7064-24 Walgreens 6 tablets — — FDA listed —
Mucus Relief D 1200 mg/1; 120 mg 11822-7399-04 Rite 6 tablets — — FDA listed —
Mucus Relief D 1200 mg/1; 120 mg 49035-0261-12 Wal-mart 12 tablets — — FDA listed —
mucus d 1200 mg/1; 120 mg 51316-0345-62 CVS 6 tablets — — FDA listed —
MAXIMUM STRENGTH Mucus D 1200 mg/1; 120 mg 51316-0970-24 CVS 24 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 1200 mg/1; 120 mg 51660-0077-12 Ohm 12 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCL 1200 mg/1; 120 mg 55111-0799-04 Dr. 6 tablets — — FDA listed —
nasal and chest decongestant 1200 mg/1; 120 mg 56062-0614-62 Publix 6 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 1200 mg/1; 120 mgthis 58602-0834-78 Aurohealth 12 tablets — — FDA listed —
mucus relief d 1200 mg/1; 120 mg 59640-0300-62 H 6 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 1200 mg/1; 120 mg 62207-0828-71 Granules 10 tablets — — FDA listed —
Mucus Relief D 1200 mg/1; 120 mg 69842-0211-24 CVS 6 tablets — — FDA listed —
mucus D 1200 mg/1; 120 mg 79481-0119-00 Meijer, 3 tablets — — FDA listed —
Equate Mucus D 1200 mg/1; 120 mg 79903-0388-24 WALMART 6 tablets — — FDA listed —
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
Mar 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
Imprint65;X
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.

🧪 Avoiding an ingredient? See Guaifenesin / Pseudoephedrine 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 Z78RG6M2N2
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material in tablets and capsules. It helps hold ingredients together and creates a protective coating that controls how quickly the medicine dissolves.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII K0KQV10C35
    Povidone K25 is a synthetic polymer made from vinyl pyrrolidone. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach for better absorption.
  • 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.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statescolloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

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

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA213203 (ANDA)
Labeler code58602
First marketedMar 2020
Product typeHuman Otc Drug
Portfolio179 products on file

More NDCs from Aurohealth LLC labeler code 58602

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 53 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 58 words ▾

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use

⚠️ Warnings 56 words ▾

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📦 Storage and Handling 10 words ▾

Other information store at 20 to 25°C (68 to 77°F)

🧪 Active Ingredient 15 words ▾

Active ingredients (in each extended-release tablet) Guaifenesin USP 1200 mg Pseudoephedrine HCl USP 120 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

🎯 Purpose 4 words ▾

Purposes Expectorant Nasal Decongestant

📄 Ask a Doctor Before Use If 45 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

📄 When Using This Product 10 words ▾

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days, come back or occur with a 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).

📄 Questions or Comments 27 words ▾

Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016

📄 Package Label / Principal Display Panel 80 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/120 mg (12 Tablet Carton Label) AUROHEALTH NDC 58602-834-77 *Compare to the active ingredients of Mucinex ® D MAXIMUM STRENGTH Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets 1200 mg/120 mg Guaifenesin 1200 mg - Expectorant Pseudoephedrine HCl 120 mg - Nasal Decongestant RELIEVES NASAL & CHEST CONGESTION 12 HOUR • Clears Nasal & Sinus Congestion • Thins & Loosens Mucus 12 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/120 mg (12 Tablet Carton Label)

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 Guaifenesin and Pseudoephedrine HCl — the ingredient across all brands.

Top reported reactions

Emotional Distress3
Pain3
Abdominal Pain Upper2
Anxiety2
Asthma2
Dyspnoea2
Fatigue2

Age at onset

Adult4
Elderly1

Reporter sex

20 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization5
Disabling2
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5 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 Aurohealth LLC. 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 1 other package presentation of this same product, including 12 tablets (58602-0834-77). 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?
Aurohealth 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.
← 58602-0833-12 · Aurohealth 58602-0835-07 · Aurohealth →
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.