⚪image loading
(from DailyMed)

Sinus and Headache Daytime Acetaminophen, Phenylephrine HCl 325 mg; 5 mg Tablet, Film Coated

by L.N.K. International, Inc. · 2 BLISTER PACK in 1 CARTON (50844-467-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK
NDC 50844-0467-08
🏷️ FDA NDC (as labeled) 50844-467-08 billing pads the product segment with a zero
This package
Contains12 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Also comes in: 12 tablets 50844-0467-02
OTC On market Non-controlled
🗂️ Data synced Sep 3, 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) 50844-467-08
Product NDC 50844-467
11-digit billing NDC 50844046708
RxCUI 1046378
UNII 362O9ITL9D, 04JA59TNSJ
UPC 0050844466081
Application # M012
SPL Set ID e20b1093-d77f-4c39-b105-adaa1b82ea76
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-07-26
Marketing end 2027-03-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 50844-467-08 — 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 → 50844-0467-08. 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 Anilides class.

Drug family (ATC) Anilides
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

LabelerL.N.K. International, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50844
First marketedJul 2005
Product typeHuman Otc Drug
Portfolio64 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

🧪 What is this product?

This is an over-the-counter oral tablet that combines two active ingredients commonly used together for sinus congestion and headache relief. Acetaminophen is typically used to reduce pain and fever, while phenylephrine hydrochloride is a nasal decongestant that functions to help relieve sinus pressure and congestion. The tablet is film-coated to make it easier to swallow. This product is marketed under the FDA's over-the-counter monograph system, which sets standard rules for combination cold and sinus products in this category.

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 green
ShapeOval
Imprint44;466
Size17 mm
ScoringNot scored
FlavorMenthol
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.

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 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: 12 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
Sinus Congestion and Pain Maximum Strength 325 mg/1; 5 mg 00536-1289-35 Rugby 24 tablets $0.085 — Availability likely —
Sinus Pressure Pain Maximum Strength, Non-Drowsy 325 mg/1; 5 mg 46122-0443-62 Amerisource 24 tablets $0.085 — Availability likely —
Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 70000-0161-01 Cardinal 24 tablets $0.085 — Availability likely —
Sinus and Headache 325 mg/1; 5 mg 70000-0568-01 Cardinal 12 tablets $0.085 — Availability likely —
Sinus plus Headache 325 mg/1; 5 mg 83324-0094-24 CHAIN 12 tablets $0.085 — Availability likely —
Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-0607-02 Haleon 8 tablets — — FDA listed —
Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-7031-01 Haleon 2 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 00363-4066-08 Walgreen 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 11822-4669-08 Rite 12 tablets — — FDA listed —
Sinus Pressure and Pain PE Maximum Strength 325 mg/1; 5 mg 11822-5022-08 Rite 24 tablets — — FDA listed —
Pain Relief Non Drowsy Daytime 325 mg/1; 5 mg 21130-0466-08 Better 12 tablets — — Discontinued —
Pain Relief Sinus Congestion 325 mg/1; 5 mg 21130-0474-08 Better 12 tablets — — FDA listed —
Sinus Relief MAXIMUM STRENGTH 325 mg/1; 5 mg 21130-0502-21 Better 24 tablets — — FDA listed —
Sinus Plus Headache 325 mg/1; 5 mg 30142-0466-08 Kroger 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 36800-0320-06 TOPCO 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 36800-0322-05 TOPCARE 12 tablets — — FDA listed —
Sinus Congestion and Pain Daytime Non-Drowsy 325 mg/1; 5 mg 37808-0466-08 H 12 tablets — — FDA listed —
Sinus Congestion and Pain Daytime 325 mg/1; 5 mg 41163-0664-08 United 12 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 42507-0223-05 HYVEE 12 tablets — — FDA listed —
Sinus Pressure and Pain PE 325 mg/1; 5 mg 42507-0320-06 HYVEE 12 tablets — — FDA listed —
Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 50580-0435-01 Kenvue 12 tablets — — FDA listed —
SUDAFED PE Pressure Plus Pain 325 mg/1; 5 mg 50580-0547-25 Kenvue 12 tablets — — FDA listed —
Tylenol Sinus Plus Headache Day 325 mg/1; 5 mg 50580-0598-01 Kenvue 12 tablets — — Discontinued —
Sinus and Headache 325 mg/1; 5 mg 50804-0123-05 GOODSENSE 12 tablets — — FDA listed —
sinus pressure and pain pe 325 mg/1; 5 mg 50804-0220-06 GOODSENSE 12 tablets — — FDA listed —
Sinus and Headache Daytime 325 mg/1; 5 mgthis 50844-0467-08 L.N.K. 12 tablets — — FDA listed —
Coltalin-Nd 325 mg/1; 5 mg 51467-0008-01 FORTUNE 24 tablets — — FDA listed —
Coltalin-Nd 325 mg/1; 5 mg 51467-0013-01 FORTUNE 24 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 53943-0220-06 DISCOUNT 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 53943-0323-05 DISCOUNT 12 tablets — — FDA listed —
Sinus Headache and Pain Day, Non-drowsy 325 mg/1; 5 mg 55301-0446-08 ARMY 12 tablets — — FDA listed —
Suphedrine PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 55301-0902-08 ARMY 24 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 55319-0496-08 Family 12 tablets — — FDA listed —
Sinus Pressure and Pain 325 mg/1; 5 mg 55319-0702-08 Family 24 tablets — — FDA listed —
Sinus and Headache Daytime 325 mg/1; 5 mg 55910-0466-08 DOLGENCORP, 12 tablets — — FDA listed —
Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 55910-0925-08 DOLGENCORP, 24 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 57344-0923-05 AAA 12 tablets — — FDA listed —
Sinus Pain And Congestion Daytime 325 mg/1; 5 mg 59779-0466-08 CVS 12 tablets — — FDA listed —
Sinus PE Pressure plus Pain MAXIMUM STRENGTH 325 mg/1; 5 mg 59779-0802-08 CVS 24 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 63868-0582-24 CHAIN 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 63941-0220-06 VALU 12 tablets — — FDA listed —
Nasal Decongestant PE and Pain Relief Maximum Strength 325 mg/1; 5 mg 67091-0209-24 WinCo 24 tablets — — FDA listed —
Sinus Congestion and Pain Relief Non-Drowsy 325 mg/1; 5 mg 67091-0213-24 WinCo 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 68998-0220-06 MARC 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 68998-0323-05 MARC 12 tablets — — FDA listed —
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy 325 mg/1; 5 mg 69168-0270-95 Allegiant 18 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72036-0320-06 Harris 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 72036-0323-05 Harris 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72476-0120-06 RETAIL 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 72476-0123-05 RETAIL 12 tablets — — FDA listed —
Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 85766-0183-24 Sportpharm 12 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2005
On the market since
Jul 2005
📍
2026
Currently FDA-listed
21 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Acetaminophen, Phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Pneumonia6
Headache5
Nausea5
Back Pain4
Sinusitis4
Abdominal Pain Upper3
Covid-193

Age at onset

Adult2
Elderly5

Reporter sex

27 reports
Male · 41%
Female · 59%

Serious outcomes

Hospitalization4
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 5 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
50844-0467-02 1 BLISTER PACK in 1 CARTON (50844-467-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2005-07-26 Active
50844-0467-08 You're viewing this 2 BLISTER PACK in 1 CARTON (50844-467-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2005-07-26 Active

Pack size FAQ

What quantity is in NDC 50844-0467-08?
NDC 50844-0467-08 is listed by the FDA — 2 blister pack in 1 carton / 12 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Sinus and Headache Daytime Acetaminophen, Phenylephrine HCl 325 mg; 5 mg Tablet, Film Coated?
Bill NDC 50844-0467-08 — the 11-digit billing format is 50844046708. 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 50844-467-08, 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: 50844-0467-08, written without dashes as 50844046708. 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 50844-0467-08, the first segment (50844) is the labeler code FDA assigned to L.N.K. International, Inc.; the middle segment (0467) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 it is currently marketed — but L.N.K. International, Inc. has reported a marketing end date of 2027-03-31, after which this package is expected to stop being marketed. 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 12 tablets (50844-0467-02). 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?
L.N.K. International, Inc. 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 44 words ▾

Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever

⏱️ Dosage and Administration 46 words ▾

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland heart disease diabetes thyroid disease liver disease high blood pressure Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur redness or swelling is present fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 36 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

🧪 Active Ingredient 12 words ▾

Active ingredients (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

🎯 Purpose 6 words ▾

Purpose Pain reliever/fever reducer Nasal decongestant

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.