Home › NDC Lookup › Ingredients › Guaifenesin And Pseudoephedrine Hcl › 55111-0798-36
Guaifenesin and Pseudoephedrine HCL 600 mg; 60 mg Tablet, Extended Release — NDC 55111-0798-36 package photo

Guaifenesin and Pseudoephedrine HCL 600 mg; 60 mg Tablet, Extended Release

by Dr. Reddys Laboratories Limited · 4 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 55111-0798-36
🏷️ FDA NDC (as labeled) 55111-798-36 billing pads the product segment with a zero
This package
Contains9 tablet, extended release in 1 blister pack Cost per ea$0.3872 NADAC Per package$13.94 / 36 tablets Pack sizes6 compare ↓
Also comes in: 9 tablets 55111-0798-09 9 tablets 55111-0798-18 18 tablets 55111-0798-35 18 tablets 55111-0798-41 18 tablets 55111-0798-77
OTC Generic On market Non-controlled
🗂️ Data synced Aug 13, 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) 55111-798-36
Product NDC 55111-798
11-digit billing NDC 55111079836
NCPDP billing unit EA — each (per item)
RxCUI 1244675, 1305603
UNII 495W7451VQ, 6V9V2RYJ8N
Application # ANDA208369
SPL Set ID 845a2dcc-9069-3141-ae13-f2063f36d130
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 2017-12-29
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
GPI-14 43996202307435
GPI class Pseudoephedrine-guaiFENesin ER
GCN Seq No 012073
GCN 54980
HICL code 000270
Ingredient (HICL) Guaifenesin/Pseudoephedrne Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4W
Therapeutic class — specific (HIC3) Decongestant-Expectorant Combinations
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name GUAIFENESIN-PSE ER 600-60 MG
FDB brand name Guaifenesin-Pseudoephedrine Er
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 55111-798-36 — 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 → 55111-0798-36. 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

LabelerDr. Reddys Laboratories Limited
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA208369 (ANDA)
Labeler code55111
First marketedDec 2017
Product typeHuman Otc Drug
Portfolio32 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GUAIFENESIN-PSE ER 600-60 MG Ingredient Guaifenesin/Pseudoephedrne Hcl
📗 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 →

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 Orange
ShapeCapsule
ImprintRDY;799
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 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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.

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

The official label also statesFD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.387 $13.94 / 36 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 Jan 2024 Mar 2026 Aug 2026 $0.462 $0.310
▼ Down 16% over the last 16 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 70677-1011-01 Strategic 18 tablets $0.357 — FDA listed save 8%
mucus D 600 mg/1; 60 mg 00113-8307-68 L. 18 tablets $0.387 — Availability likely —
Guaifenesin D 600 mg/1; 60 mg 00536-1333-21 RUGBY 18 tablets $0.387 — Availability likely —
Rugby Mucus Relief D 600 mg/1; 60 mg 00536-1449-21 Rugby 18 tablets $0.387 — Availability likely —
Guaifenesin and Pseudoephedrine HCL 600 mg/1; 60 mgthis 55111-0798-36 Dr. 9 tablets $0.387 — Availability likely —
Leader Mucus Relief D 600 mg/1; 60 mg 70000-0720-01 Cardinal 18 tablets $0.387 — Availability likely —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 70677-1263-01 Strategic 18 tablets $0.387 — Availability likely —
foster and thrive mucus relief d 600 mg/1; 60 mg 70677-1272-01 Strategic 18 tablets $0.387 — Availability likely —
Mucinex D 600 mg/1; 60 mg 63824-0057-18 Reckitt 18 tablets $0.704 — FDA listed +82%
Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1; 60 mg 00363-0077-18 WALGREEN 18 tablets — — FDA listed —
Mucus Relief D 600 mg/1; 60 mg 00363-1604-15 Walgreens 18 tablets — — FDA listed —
Mucus Relief D 600 mg/1; 60 mg 00363-8708-68 Walgreen 18 tablets — — FDA listed —
Guaifenesin D 600 mg/1; 60 mg 00363-9930-18 Walgreen 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 00363-9946-40 WALGREEN 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 11822-0046-01 Rite 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 30142-0137-12 KROGER 18 tablets — — FDA listed —
mucus d 600 mg/1; 60 mg 30142-0739-68 Kroger 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1; 60 mg 41415-0994-18 PUBLIX 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 46122-0801-08 Amerisource 18 tablets — — FDA listed —
Mucinex D 600 mg/1; 60 mg 50090-1075-00 A-S 18 tablets — — FDA listed —
Mucinex D 600 mg/1; 60 mg 50090-1076-00 A-S 9 tablets — — FDA listed —
Mucus D 600 mg/1; 60 mg 51316-0878-68 CVS 18 tablets — — FDA listed —
Guaifenesin D 600 mg/1; 60 mg 51316-0993-18 CVS 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 51660-0074-18 Ohm 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 58602-0833-12 Aurohealth 18 tablets — — FDA listed —
mucus relief d 600 mg/1; 60 mg 59640-0621-89 H 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1; 60 mg 62011-0475-01 STRATEGIC 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 62207-0827-72 Granules 10 tablets — — FDA listed —
Mucus D 600 mg/1; 60 mg 69842-0095-18 CVS 18 tablets — — FDA listed —
Mucus D 600 mg/1; 60 mg 79481-0709-01 Meijer, 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 79481-1002-01 Meijer 18 tablets — — FDA listed —
equate mucus d 600 mg/1; 60 mg 79903-0125-18 WALMART 18 tablets — — 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
18 tablets55111-0798-35 56 Rx · $896
9 tablets55111-0798-18 37 Rx · $428
18 tablets55111-0798-41 15 Rx · $69
9 tablets55111-0798-09 No Medicaid data
9 tablets this page55111-0798-36 No Medicaid data
18 tablets55111-0798-77 No Medicaid data
Drug total (last 4 qtrs): 108 Rx · 2,023 units · $1,393 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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
Death1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 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 Per unit Per pack Marketing startStatus
55111-0798-09 1 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK — — 2017-12-29 Active
55111-0798-18 2 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.3872 / ea $6.97 2017-12-29 Active
55111-0798-35 1 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.3872 / ea $6.97 2020-01-23 Active
55111-0798-36 You're viewing this 4 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.3872 / ea $13.94 2017-12-29 Active
55111-0798-41 2 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK $0.3872 / ea $13.94 2020-03-11 Active
55111-0798-77 6 BLISTER PACK in 1 CARTON (55111-798-77) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK — — — Active

This pack effectively ties for the lowest per-ea cost of the 4 priced pack sizes ($0.3872 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 55111-0798-36?
NDC 55111-0798-36 is listed by the FDA — 4 blister pack in 1 carton / 9 tablet, extended release in 1 blister pack.
What NDC number is used to bill for this package of Guaifenesin and Pseudoephedrine HCL 600 mg; 60 mg Tablet, Extended Release?
Bill NDC 55111-0798-36 — the 11-digit billing format is 55111079836. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 62 words ▾

Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some 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 94 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 ■ children under 12 years of age: do not use For 600 mg/60 mg ■ adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg ■ adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours

⚠️ Warnings 187 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. Ask a doctor before use if ■ 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 ■ do not use more than directed Stop use and ask 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. Pregnancy/Breastfeeding ask a health professional before use. 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).

📦 Storage and Handling 6 words ▾

Storage ■ store between 20°-25°C (68°-77°F)

🧪 Active Ingredient 22 words ▾

Active ingredient(s) Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

🎯 Purpose 5 words ▾

Purpose Expectorant and Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55111-0797-01 · DR 55111-0799-04 · Dr. →
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.