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Aleve-D Sinus and Headache naproxen sodium, pseudoephedrine hydrochloride 220 mg; 120 mg Tablet, 10-count — NDC 00280-6045-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aleve-D Sinus and Headache naproxen sodium, pseudoephedrine hydrochloride 220 mg; 120 mg Tablet, 10-count — NDC 0280-6045-10 (Billing 00280-6045-10)

by Bayer HealthCare LLC. · 1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

This is a package of 10 tablets of Aleve-D Sinus and Headache naproxen sodium, pseudoephedrine hydrochloride 220 mg; 120 mg Tablet from Bayer HealthCare LLC., marketed since Jan 2014 and currently FDA-listed. It is this product's only package size.

NDC 00280-6045-10
🏷️ FDA NDC (as labeled) 0280-6045-10 billing pads the labeler segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0280-6045-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0280 labeler · 6045 product · 10 package
Package marketed since
Jan 1, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0325866569516
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-6045-10
Product NDC 0280-6045
11-digit billing NDC 00280604510
RxCUI 1367426
UNII 9TN87S3A3C, 6V9V2RYJ8N
UPC 0325866569516
Application # ANDA076518
SPL Set ID 5ab980c0-c48a-233b-e053-2991aa0a4fd1
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-01
Route ORAL
Dosage form TABLET
Substance NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1367426
Why two NDCs? The FDA registers this code as 0280-6045-10 — 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 → 00280-6045-10. 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) Propionic acid derivatives, Antiinflammatory products for vaginal administration, Antiinflammatory preparations, non-steroids for topical use
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.

Clinical

📖 What it is MedlinePlus · NLM

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of th...

Read the full MedlinePlus article ↗

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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00280-6045-10 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2014-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader All Day Sinus and Cold D 220 mg/1; 120 mg 70000-0605-01 Cardinal 1 tablet $0.244 — Availability likely —
Aleve-D Sinus and Headache 220 mg/1; 120 mgthis 00280-6045-10 Bayer 10 tablets — — FDA listed —
Aleve-D Sinus and Cold 120 mg/1; 220 mg 00280-6090-10 Bayer 10 tablets — — FDA listed —
All Day Sinus and Cold D 220 mg/1; 120 mg 00363-0650-01 Walgreen 1 tablet — — FDA listed —
Topcare Sinus and Cold D 220 mg/1; 120 mg 36800-0417-01 Topco 1 tablet — — FDA listed —
Sinus and Cold D 220 mg/1; 120 mg 41250-0417-01 Meijer 1 tablet — — FDA listed —
Sudafed Sinus 12 Hour Pressure plus Pain 220 mg/1; 120 mg 50580-0434-01 Kenvue 8 tablets — — FDA listed —
Sinus and Cold D 220 mg/1; 120 mg 51316-0339-01 CVS 1 tablet — — FDA listed —
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg/1; 120 mg 58602-0816-67 Aurohealth 10 tablets — — FDA listed —
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache 220 mg/1; 120 mg 58602-0832-67 Aurohealth 10 tablets — — FDA listed —
Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus 220 mg/1; 120 mg 71179-0816-24 VESPYR 8 tablets — — 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color white
ShapeOval
ImprintAleve;D
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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesInactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

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.

Manufacturer & labeler

LabelerBayer HealthCare LLC.
Application holderL PERRIGO CO
FDA applicationANDA076518 (ANDA)
Labeler code00280
First marketedJan 2014
Product typeHuman Otc Drug
Portfolio240 products on file

More NDCs from Bayer HealthCare LLC. labeler code 00280

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 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever

⏱️ Dosage and Administration 67 words ▾

Directions • do not take more than directed • the smallest effective dose should be used • swallow whole ; do not crush or chew • drink a full glass of water with each dose • adults and children 12 years and older: 1 caplet every 12 hours ; do not take more than 2 caplets in 24 hours • children under 12 years: do not use

⚠️ Warnings 170 words ▾

Warnings Allergy alert : Naproxen sodium 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 20 words ▾

Active ingredients (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

🎯 Purpose 6 words ▾

Purposes Pain reliever/fever reducer Nasal decongestant

📄 Do Not Use 86 words ▾

Do not use • 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. • in children under 12 years of age

📄 Ask a Doctor Before Use If 76 words ▾

Ask a doctor before use if • the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease,asthma • thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland or had a stroke • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers

📄 Ask a Doctor or Pharmacist Before Use If 24 words ▾

Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other drug

📄 When Using This Product 14 words ▾

When using this product • take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 121 words ▾

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 ● redness or swelling is present in the painful area ● any new symptoms appear ● fever gets worse or lasts more than 3 days ● you have difficulty swallowing or the caplet feels stuck in your throat ● you get nervous, dizzy, or sleepless ● nasal congestion lasts more than 7 days

🤰 If Pregnant or Breast-Feeding 48 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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 22 words ▾

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 23 words ▾

Other Information Other information • each caplet contains : sodium 21 mg • store at 20-25°C (68-77°F) • store in a dry place

📄 Questions or Comments 11 words ▾

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

📄 Package Label / Principal Display Panel 56 words ▾

See New Warnings NON-DROWSY ALL DAY STRONG® ALEVE-D® SINUS & HEADACHE Naproxen sodium 220 mg (NSAID) Pseudoephedrine HCl 120 mg extended-release tablets Pain reliever-fever reducer/nasal decongestant 12 HOUR MULTI-SYMPTOM RELIEF OF SINUS PRESSURE HEADACE · SINUS CONGESTION NASAL CONGESTION actual size 1 CAPLET - 12 HOURS 10 CAPLETS CAPSULE-SHAPED TABLETS Aleve D Sinus and Headache label

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 Aleve-D Sinus and Headache (this brand).

Top reported reactions

Drug Effective For Unapproved Indication4
Back Pain2
Therapeutic Product Effect Delayed2
Abdominal Discomfort1
Adverse Event1
Ankylosing Spondylitis1
Arthralgia1

Age at onset

Child1
Adult3

Reporter sex

15 reports
Male · 56%
Female · 44%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 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.

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 ✓ Available
Inactive ingredients (structured) ✓ 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 Bayer HealthCare LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer HealthCare LLC. 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.
← 00280-6020-02 · Bayer 00280-6050-01 · Bayer →
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.