Guaifenesin and Pseudoephedrine HCl 600 mg; 60 mg Tablet, Extended Release — NDC 0363-9946-45 (Billing 00363-9946-45)
by WALGREEN CO. · 2 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
This is a package of Guaifenesin and Pseudoephedrine HCl 600 mg; 60 mg Tablet, Extended Release from WALGREEN CO., marketed since May 2022 and currently FDA-listed.
NDC 00363-9946-45
🏷️ FDA NDC (as labeled)
0363-9946-45
billing pads the labeler segment with a zero
This package
Contains18 tablet, extended release in 1 blister pack
Pack sizes2 compare ↓
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0363-9946-45
Product NDC
0363-9946
11-digit billing NDC
00363994645
RxCUI
1305603
UNII
495W7451VQ, 6V9V2RYJ8N
Application #
ANDA213203
SPL Set ID
cc1ac1b4-cbc4-539c-e053-2a95a90a5b75
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
2022-05-07
Route
ORAL
Dosage form
TABLET, EXTENDED RELEASE
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1305603
Why two NDCs?
The FDA registers this code as 0363-9946-45 — a 4-4-2 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 labeler segment → 00363-9946-45. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📗 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...
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Guaifenesin and Pseudoephedrine HCl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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:
18 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00363-9946-40 0363-9946-40 Main listing | 1 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2022-05-07 | — | Active |
| 00363-9946-45 You're viewing this | 2 BLISTER PACK in 1 CARTON / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2022-05-07 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 18 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?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 70677-1011-01 | Strategic | 18 tablets | $0.357 | — | FDA listed | — |
| mucus D 600 mg/1; 60 mg 00113-8307-68 | L. | 18 tablets | $0.384 | — | Availability likely | — |
| Guaifenesin D 600 mg/1; 60 mg 00536-1333-21 | RUGBY | 18 tablets | $0.384 | — | Availability likely | — |
| Rugby Mucus Relief D 600 mg/1; 60 mg 00536-1449-21 | Rugby | 18 tablets | $0.384 | — | Availability likely | — |
| Leader Mucus Relief D 600 mg/1; 60 mg 70000-0720-01 | Cardinal | 18 tablets | $0.384 | — | Availability likely | — |
| Guaifenesin and Pseudoephedrine HCl 600 mg/1; 60 mg 70677-1263-01 | Strategic | 18 tablets | $0.384 | — | Availability likely | — |
| foster and thrive mucus relief d 600 mg/1; 60 mg 70677-1272-01 | Strategic | 18 tablets | $0.384 | — | Availability likely | — |
| Mucinex D 600 mg/1; 60 mg 63824-0057-18 | Reckitt | 18 tablets | $0.704 | — | FDA listed | — |
| 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 mgthis 00363-9946-45 | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.
- FDA Orange Book · refreshed Sep 3, 2026
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerWALGREEN CO.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA213203 (ANDA)
Labeler code00363
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio132 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ▾
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 ▾
Directions do not crush, chew, or break 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 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use
⚠️ Warnings ▾
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 ▾
Other information tamper evident: do not use if carton is opened or if individual blister units are torn or opened. store at 20 to 25°C (68 to 77°F)
🧪 Active Ingredient ▾
Active ingredients (in each extended-release tablet) Guaifenesin USP 600 mg Pseudoephedrine HCl USP 60 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).
🎯 Purpose ▾
Purposes Expectorant Nasal Decongestant
📄 Ask a Doctor Before Use If ▾
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 ▾
When using this product do not use more than directed
📄 Stop Use and Ask a Doctor If ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
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 ▾
Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100 % SATISFACTION GUARANTEED walgeens.com ©2021 Walgreen Co. MADE IN INDIA Code: AP/DRUGS/04/2016
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label) NDC 0363-9946-40 Walgreens Compare to the active Ingredients of Mucinex ® D †† Mucus Relief D GUAIFENESIN USP 600 mg / EXPECTORANT PSEUDOEPHEDRINE HCl USP 60 mg / NASAL DECONGESTANT EXTENDED-RELEASE TABLETS 12 Hour • Clears nasal/sinus congestion • Thins & loosens mucus 18 EXTENDED- RELEASE TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label)
No label section mentions that — try another word, or open the full label on DailyMed below.
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
Age at onset
Reporter sex
Male · 35%
Female · 65%
Serious outcomes
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.
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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 WALGREEN CO.. 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 18 tablets (00363-9946-40). 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?
WALGREEN CO. 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.
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.