Ibuprofen and Pseudoephedrine HCl 200 mg; 30 mg Capsule, Liquid Filled
by WALGREEN CO. · 2 BLISTER PACK in 1 CARTON (0363-1106-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 00363-1106-67
🏷️ FDA NDC (as labeled)
0363-1106-67
billing pads the labeler segment with a zero
This package
Contains10 capsule, liquid filled in 1 blister pack
Pack sizes2 compare ↓
Also comes in:
10 capsules 00363-1106-08
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 →
🆔 Identity & classification
FDA NDC (as labeled)
0363-1106-67
Product NDC
0363-1106
11-digit billing NDC
00363110667
RxCUI
1299018
UNII
WK2XYI10QM, 6V9V2RYJ8N
Application #
ANDA209235
SPL Set ID
1cc6e3f0-64f7-4974-a62c-5db46ca9e7c5
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
On market
FDA listing status
Listed (active directory)
Marketing start
2017-12-01
Route
ORAL
Dosage form
CAPSULE, LIQUID FILLED
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 0363-1106-67 — 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 → 00363-1106-67. 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 CO.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA209235 (ANDA)
Labeler code00363
First marketedDec 2017
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.
🩺 Clinical
📗 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...
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.
💬 Questions about Ibuprofen and Pseudoephedrine HCl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.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 mL | 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:
10 capsules
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 |
|---|---|---|---|---|---|---|
| Ibuprofen and Pseudoephedrine HCl 200 mg/1; 30 mgthis 00363-1106-67 | WALGREEN | 10 capsules | — | — | FDA listed | — |
| Advil Cold And Sinus 200 mg/1; 30 mg 00573-0184-16 | Haleon | 1 capsule | — | — | FDA listed | — |
| Ibuprofen and Pseudoephedrine HCl 200 mg/1; 30 mg 46122-0609-58 | Amerisource | 10 capsules | — | — | FDA listed | — |
| Ibuprofen and Pseudoephedrine HCl 200 mg/1; 30 mg 58602-0803-03 | Aurohealth | 10 capsules | — | — | FDA listed | — |
| Ibuprofen and Pseudoephedrine HCl 200 mg/1; 30 mg 69842-0092-13 | CVS | 8 capsules | — | — | FDA listed | — |
| Ibuprofen and Pseudoephedrine HCl 200 mg/1; 30 mg 70000-0606-01 | CARDINAL | 10 capsules | — | — | 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
🏛️
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.
🔬 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 HCL — the ingredient across all brands.
Top reported reactions
Reporter sex
Male · 64%
Female · 36%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00363-1106-08 | 4 BLISTER PACK in 1 CARTON (0363-1106-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2017-12-01 | Active |
| 00363-1106-67 You're viewing this | 2 BLISTER PACK in 1 CARTON (0363-1106-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2017-12-01 | Active |
Pack size FAQ
What quantity is in NDC 00363-1106-67?
NDC 00363-1106-67 is listed by the FDA — 2 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of Ibuprofen and Pseudoephedrine HCl 200 mg; 30 mg Capsule, Liquid Filled?
Bill NDC 00363-1106-67 — the 11-digit billing format is 00363110667. 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 | — 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 FDA registers it as 0363-1106-67, 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: 00363-1106-67, written without dashes as 00363110667. 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 00363-1106-67, the first segment (00363) is the labeler code FDA assigned to WALGREEN CO.; the middle segment (1106) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (67) 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 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 10 capsules (00363-1106-08). 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.
📄 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 ▾
Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
⏱️ Dosage and Administration ▾
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 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. ● do not use more than 6 capsules in any 24-hour period unless directed by a doctor ● children under 12 years of age: do not use Other information each capsule contains: potassium 20 mg store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use.
Keep carton.
⚠️ Warnings ▾
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.
🧪 Active Ingredient ▾
Drug Facts Active ingredients (in each liquid-filled capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) Pseudoephedrine Hydrochloride USP 30 mg *nonsteroidal anti-inflammatory drug
🧪 Inactive Ingredients ▾
Inactive ingredients Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution. Questions or comments? call 1-855-274-4122 Product inside sealed in blister with foil backing. Do not use if blister or foil barrier is broken. DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015 walgreens.com ©2023 Walgreen Co. MADE IN INDIA Code: TS/DRUGS/16/2014
🎯 Purpose ▾
Purposes Pain reliever/fever reducer Nasal decongestant
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 ↗
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.