Home › NDC Lookup › Ingredients › Guaifenesin And Pseudoephedrine Hcl › 70677-1263-01
⚪image loading
(from DailyMed)

Guaifenesin and Pseudoephedrine HCl 600 mg; 60 mg Tablet, Extended Release, 18-count

by Strategic Sourcing Services LLC · 1 BLISTER PACK in 1 CARTON (70677-1263-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 70677-1263-01
🏷️ FDA NDC (as labeled) 70677-1263-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 70677-1263-1
Product NDC 70677-1263
11-digit billing NDC 70677126301
NCPDP billing unit EA — each (per item)
RxCUI 1305603
UNII 495W7451VQ, 6V9V2RYJ8N
Application # ANDA212542
SPL Set ID 27f85134-cd38-b33c-e063-6394a90a05a8
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 2024-12-13
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
GPI-14 43996202307435
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 FT MUCUS RELIEF D ER 600-60 MG
FDB brand name Mucus Relief D
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-1263-1 — a 5-4-1 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 package segment → 70677-1263-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerStrategic Sourcing Services LLC
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationANDA212542 (ANDA)
Labeler code70677
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio316 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 FT MUCUS RELIEF D ER 600-60 MG Ingredient Guaifenesin/Pseudoephedrne Hcl
📖 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 →

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
ShapeOval
Imprint058
Size17 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 HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII 0HO1H52958
    Hypromellose 2910 is a plant-derived cellulose that forms a protective coating around tablets or capsules. It slows how fast the medicine releases, helps protect the active ingredient, and improves how the product looks.
  • 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 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.

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

The official label also statescarbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

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 $6.97 / 18 tablets
Medicaid paysCMS SDUD · 12 mo $0.2710 $4.88 / 18 tablets
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
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.389 $0.310
▲ Up 25% over the last 9 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 —
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 mgthis 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 55111-0798-09 Dr. 9 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70677-1263-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q2 2025 – Q4 2025 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
16
Units reimbursed last 4 qtrs
300
Gross reimbursed last 4 qtrs
$81.31
Avg / prescription
$5.08
Avg / unit
$0.2710
Latest quarter Q4 2025
16Rx
Medicaid pays / ea
$0.2710
gross reimbursed
vs
NADAC / ea
$0.3872
acquisition cost
=
Spread
−$0.1162
-30% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 16 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 300 units · 4.0 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.04.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arizona 4.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Marketing startStatus
70677-1263-01 You're viewing this 1 BLISTER PACK in 1 CARTON (70677-1263-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2024-12-13 Active

📄 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 🧪 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 83 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: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours children under 12 years of age: do not use Other Information Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. store between 20-25°C (68-77°F)

⚠️ Warnings 184 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 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 do not use more than directed 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 , 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).

🧪 Active Ingredient 17 words ▾

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant

🧪 Inactive Ingredients 13 words ▾

Inactive Ingredients carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

🎯 Purpose 17 words ▾

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70677-1262-01 · STRATEGIC 70677-1264-01 · Strategic →
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.