NDC 58602-0834-78 — Guaifenesin and Pseudoephedrine HCl 1200 mg;

🆔 Identity & classification

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

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.

🏭 Manufacturer & labeler

LabelerAurohealth LLC

Application holderAUROBINDO PHARMA LTD

FDA applicationANDA213203 (ANDA)

Labeler code58602

First marketedMar 2020

Product typeHuman Otc Drug

Portfolio174 products on file

🔎 All NDCs from Aurohealth LLC

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

📖 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

Yes, each ingredient does something different. Guaifenesin works on your chest — it thins and loosens the mucus in your airways so it's easier to cough up. Pseudoephedrine works on...
What does this medicine actually do — do I need both ingredients?
No — please don't. Extended-release tablets are designed to release the medicine slowly over about 12 hours. Crushing, chewing, or breaking them releases the whole dose at once, wh...
Can I crush or cut the extended-release tablet if it's hard to swallow?

📖 Read our full Guaifenesin / Pseudoephedrine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 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.

💡 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.

💲 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 each	Per 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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.

🔬 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

Male · 35%

Female · 65%

Serious outcomes

Hospitalization5

Disabling2

Death1

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
58602-0834-77	1 BLISTER PACK in 1 CARTON (58602-834-77) / 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 (58602-834-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2020-03-25	Active

Pack size FAQ

What quantity is in NDC 58602-0834-78?

NDC 58602-0834-78 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?

Bill NDC 58602-0834-78 — the 11-digit billing format is 58602083478. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 58602-834-78, 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: 58602-0834-78, written without dashes as 58602083478. 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 58602-0834-78, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0834) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (78) 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 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.

📄 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 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

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

🔗 Related NDC lookups

🧪 All Guaifenesin And Pseudoephedrine Hcl NDCsSame ingredient 🏭 All Aurohealth labeler NDCsLabeler code 58602 📚 All Expectorant NDCsDrug class