SUDAFED PE Pressure Plus Pain acetaminophen and phenylephrine hydrochloride 325 mg; 5 mg Tablet, Film Coated
by Kenvue Brands LLC · 2 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK
NDC 50580-0547-25
🏷️ FDA NDC (as labeled)
50580-547-25
billing pads the product segment with a zero
OTC
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)
50580-547-25
Product NDC
50580-547
11-digit billing NDC
50580054725
NCPDP billing unit
EA — each (per item)
RxCUI
1046378
UNII
362O9ITL9D, 04JA59TNSJ
Application #
M012
SPL Set ID
8538c291-9ce9-4866-b268-f4cbdb52f5bd
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
2012-07-01
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
GCN Seq No
059707
GCN
25468
HICL code
000436
Ingredient (HICL)
Phenylephrine Hcl/Acetaminophn
HIC1 code
B
Therapeutic class — broad (HIC1)
Respiratory System
HIC2 code
B4
Therapeutic class — intermediate (HIC2)
Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code
B4T
Therapeutic class — specific (HIC3)
Decongest-Analgesic,Non-Salicylate Comb.
AHFS code
12:12.04.00
AHFS class
Alpha-Adrenergic Agonists (12:12)
FDB label name
SUDAFED PE PRESSURE-PAIN CPLT
FDB brand name
Sudafed Pe Pressure-Pain
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50580-547-25 — 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 → 50580-0547-25. 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
LabelerKenvue Brands LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedJul 2012
Product typeHuman Otc Drug
Portfolio567 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 SUDAFED PE PRESSURE-PAIN CPLT Ingredient Phenylephrine Hcl/Acetaminophn
🧪 What is this product?
Sudafed PE Pressure Plus Pain is an over-the-counter oral tablet made under FDA's OTC drug rules. It contains acetaminophen, which is typically used to reduce fever and relieve minor aches and pains, and phenylephrine hydrochloride, a decongestant commonly used to help relieve nasal congestion. The combination is intended for people seeking both pain relief and congestion relief in a single tablet.
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 acetaminophen and phenylephrine hydrochloride?
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 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.
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 |
|---|---|---|---|---|---|---|
| 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 mgthis 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 mg 50844-0467-02 | 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
🏛️
2012
On the market since
Jul 2012
📍
2026
Currently FDA-listed
14 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 SUDAFED PE Pressure Plus Pain (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 56%
Female · 44%
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 |
|---|---|---|---|
| 50580-0547-25 You're viewing this | 2 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2012-07-01 | Active |
🧭 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) | — 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 50580-547-25, 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: 50580-0547-25, written without dashes as 50580054725. 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 50580-0547-25, the first segment (50580) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0547) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) 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 Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kenvue Brands 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.
📄 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 ▾
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
⚠️ Warnings ▾
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include: skin reddening blisters rash 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 liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away.
(1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information store between 20-25°C (68-77°F) do not use if carton is opened or if blister unit is broken
🧪 Active Ingredient ▾
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant
🧪 Inactive Ingredients ▾
Inactive ingredients carnauba wax, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide
🎯 Purpose ▾
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg 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.