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Ibuprofen and Pseudoephedrine Hydrochloride 200 mg; 30 mg Tablet, Coated, 40-count

by WALGREEN COMPANY · 40 TABLET, COATED in 1 BLISTER PACK (0363-0423-41)
NDC 00363-0423-41
🏷️ FDA NDC (as labeled) 0363-0423-41 billing pads the labeler segment with a zero
This package
Contains40-count Pack sizes2 compare ↓
Also comes in: 20 tablets 00363-0423-21
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0363-0423-41
Product NDC 0363-0423
11-digit billing NDC 00363042341
NCPDP billing unit EA — each (per item)
RxCUI 1299021
UNII WK2XYI10QM, 6V9V2RYJ8N
Application # ANDA074567
SPL Set ID c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2017-08-01
Marketing end 2026-08-31
Route ORAL
Dosage form TABLET, COATED
Substance IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
GCN Seq No 013742
GCN 92250
HICL code 004879
Ingredient (HICL) Ibuprofen/Pseudoephedrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B5
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.2)
HIC3 code B5G
Therapeutic class — specific (HIC3) Decongestant-Nsaid, Cox Non-Spec Comb.
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name WAL-PROFEN COLD & SINUS CPLT
FDB brand name Wal-Profen
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0363-0423-41 — 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 → 00363-0423-41. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
How it works Cyclooxygenase Inhibitors
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

LabelerWALGREEN COMPANY
Application holderOHM LABORATORIES INC
FDA applicationANDA074567 (ANDA)
Labeler code00363
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio468 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 WAL-PROFEN COLD & SINUS CPLT Ingredient Ibuprofen/Pseudoephedrine Hcl
📖 What it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It combines ibuprofen — a pain reliever and fever reducer — with pseudoephedrine, a nasal decongestant. Together they tackle multiple cold and flu symptoms at once: headache, fever...
  • What exactly does this medication do, and when should I use it?
  • You don't have to, but if your stomach feels upset after taking it, try taking it with food or milk. That simple step can make a big difference in tolerability, especially if your...
  • If your fever lasts more than 3 days or your nasal congestion sticks around longer than 7 days, stop taking it and call your doctor — those can be signs of something that needs mor...
📖 Read our full Ibuprofen / 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

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 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: 20 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 62011-0070-01 Strategic 20 tablets $0.164 — FDA listed —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mgthis 00363-0423-41 WALGREEN 40 tablets — — Discontinued —
Advil Cold And Sinus 200 mg/1; 30 mg 00573-0180-10 Haleon 10 tablets — — FDA listed —
Advil Cold And Sinus 200 mg/1; 30 mg 00573-2160-74 Haleon 10 tablets — — FDA listed —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 11822-0084-05 Rite-Aid 20 tablets — — FDA listed —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 30142-0423-41 The 40 tablets — — Discontinued —
Ibuprofen and Pseudoephedrine hydrochloride 200 mg/1; 30 mg 51660-0423-21 Ohm 20 tablets — — FDA listed —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 51660-0490-41 Ohm 40 tablets — — Discontinued —
Ibuprofen and Pseudoephedrine hydrochloride 200 mg/1; 30 mg 51660-0493-41 Ohm 40 tablets — — Discontinued —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 56062-0423-21 Publix 20 tablets — — Discontinued —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 58602-0839-13 Aurohealth 8 tablets — — FDA listed —
Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1; 30 mg 59779-0430-41 CVS 40 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
Aug 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.

🔬 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 Ibuprofen and pseudoephedrine hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea64
Headache62
Dizziness57
Condition Aggravated52
Insomnia50
Arthralgia46
Fatigue45

Age at onset

Adolescent1
Adult52
Elderly15

Reporter sex

1,274 reports
Male · 29%
Female · 67%
Unknown · 4%

Serious outcomes

Hospitalization117
Life-threatening13
Disabling9
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 65 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
00363-0423-21 20 TABLET, COATED in 1 BLISTER PACK (0363-0423-21) 2017-08-01 Discontinued by firm
00363-0423-41 You're viewing this 40 TABLET, COATED in 1 BLISTER PACK (0363-0423-41) 2017-08-01 Discontinued by firm

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 00363-0423-41?
NDC 00363-0423-41 is a 40-count package — 40 tablet, coated in 1 blister pack.
What is the difference between NDC 00363-0423-41 and NDC 00363-0423-21?
Both are Ibuprofen and Pseudoephedrine Hydrochloride 200 mg; 30 mg Tablet, Coated — the drug itself is identical. NDC 00363-0423-41 is the 40-count package, while NDC 00363-0423-21 is the 20 tablets package.
What NDC number is used to bill for this package of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg; 30 mg Tablet, Coated?
Bill NDC 00363-0423-41 — the 11-digit billing format is 00363042341. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0363-0423-41, 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: 00363-0423-41, written without dashes as 00363042341. 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 00363-0423-41, the first segment (00363) is the labeler code FDA assigned to WALGREEN COMPANY; the middle segment (0423) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (41) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 tablets (00363-0423-21). 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 COMPANY 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 23 words ▾

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains

⏱️ Dosage and Administration 72 words ▾

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use

⚠️ Warnings ~2 min read ▾

Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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 stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 29 words ▾

Other information store at 20 - 25° C (68 - 77° F). Avoid excessive heat above 40° C (104° F). read all warnings and directions before use. Keep carton.

🧪 Active Ingredient 24 words ▾

Active ingredients (in each caplet) Purposes Ibuprofen, USP 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl, USP 30 mg Nasal decongestant

🧪 Inactive Ingredients 64 words ▾

Inactive ingredients acacia, calcium carbonate, carnauba wax, confectioner's sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no.

6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax

🎯 Purpose 24 words ▾

Active ingredients (in each caplet) Purposes Ibuprofen, USP 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl, USP 30 mg Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00363-0421-68 · Walgreens 00363-0424-05 · Walgreen →
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.