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Sinu-Phen Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 500 mg; 5 mg Tablet, 100-count — NDC 84269-2546-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sinu-Phen Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 500 mg; 5 mg Tablet, 100-count — NDC 84269-2546-1 (Billing 84269-2546-01)

by Wildman Business Group · 50 PACKET in 1 BOX / 2 TABLET in 1 PACKET

This is a package of 100 tablets of Sinu-Phen Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 500 mg; 5 mg Tablet from Wildman Business Group, marketed since Jul 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 84269-2546-01
🏷️ FDA NDC (as labeled) 84269-2546-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 84269-2546 · Also comes in: 250 tablets 84269-2546-2
OTC 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 84269-2546-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84269 labeler · 2546 product · 1 package
Package marketed since
Jul 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8426925461 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84269-2546-1
Product NDC 84269-2546
11-digit billing NDC 84269254601
RxCUI 1101534
UNII 362O9ITL9D, 04JA59TNSJ
Application # M012
SPL Set ID c66e0b52-5531-4a84-ae90-8a26d27df1ec
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 2024-07-01
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1101534
Why two NDCs? The FDA registers this code as 84269-2546-1 — a 5-4-1 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 package segment → 84269-2546-01. 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.

Clinical

🧪 What is this product?

Sinu-Phen Plus Sinus Pain and Pressure is an over-the-counter tablet taken by mouth that contains acetaminophen and phenylephrine hydrochloride. Acetaminophen is typically used to reduce pain and fever, while phenylephrine hydrochloride is a decongestant commonly used to help relieve nasal and sinus congestion. This product is an OTC monograph drug, meaning it is marketed under FDA's established category rules for over-the-counter sinus and pain relief products rather than through an individual drug application.

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.
Try another pack size: 250 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84269-2546-01 You're viewing this Main listing 50 PACKET in 1 BOX / 2 TABLET in 1 PACKET 2024-07-01 — Active
84269-2546-02 84269-2546-2 125 PACKET in 1 BOX / 2 TABLET in 1 PACKET 2024-07-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 50 packet in 1 box / 2 tablet in 1 packet.
How does this package differ from NDC 84269-2546-02?
Both are Sinu-Phen Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 500 mg; 5 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 84269-2546-02 is the 250 tablets package.
What NDC number is used to bill for this package of Sinu-Phen Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 500 mg; 5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Green Guard Advanced Sinus Relief 500 mg/1; 5 mg 47682-0001-33 Unifirst 100 tablets — — FDA listed —
Otis Clapp Mygrex 500 mg/1; 5 mg 47682-0509-03 Unifirst 300 tablets — — FDA listed —
Medi First Sinus Pain and Pressure 500 mg/1; 5 mg 47682-0819-13 Unifirst 500 tablets — — FDA listed —
Medi First Plus Sinus Pain and Pressure 500 mg/1; 5 mg 47682-0919-33 Unifirst 100 tablets — — FDA listed —
McKesson Sinus Pain and Pressure Relief 5 mg/1; 500 mg 68599-4751-03 McKesson 500 tablets — — FDA listed —
Pain and Sinus 500 mg/1; 5 mg 73598-1192-01 JHK 100 tablets — — FDA listed —
Pain and Sinus Reliever 500 mg/1; 5 mg 73598-1194-01 JHK 500 tablets — — FDA listed —
Sinu-Phen Plus Sinus Pain and Pressure 500 mg/1; 5 mgthis 84269-2546-01 Wildman 100 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color white
ShapeRound
ImprintAZ;261
Size12 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 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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • 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 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 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesInactive ingredients corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

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

LabelerWildman Business Group
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code84269
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from Wildman Business Group labeler code 84269

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 26 words ▾

INDICATIONS & USAGE Uses temporarily relieves these common cold/flu symptoms: nasal congestion headache minor aches and pains stuffy nose sinus congestion and pressure temporarily reduces fever

⏱️ Dosage and Administration 40 words ▾

DOSAGE & ADMINISTRATION Directions do not use more than directed Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. Children under 12 years: Ask a doctor

⚠️ Warnings ~2 min read ▾

WARNINGS Warnings Liver warning: This product contains acetaminophen. 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 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. for more than 10 days unless directed by a doctor ASK DOCTOR Ask a doctor before use if you have liver disease thyroid disease diabetes high blood pressure heart disease trouble urinating due to an enlarged prostate gland ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin WHEN USING When using this product do not exceed recommended dosage.

STOP USE Stop use and ask a doctor if you get nervous, dizzy, or sleepless 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 appear These could be signs of a serious condition. PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN 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.

🧪 Active Ingredient 12 words ▾

ACTIVE INGREDIENT Active ingredients (in each tablet) Acetaminophen 500mg Phenylephrine HCl 5mg

🧪 Inactive Ingredients 17 words ▾

INACTIVE INGREDIENT Inactive ingredients corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

🎯 Purpose 7 words ▾

PURPOSE Purpose Pain reliever/fever reducer Nasal decongestant

📄 Do Not Use 92 words ▾

DO NOT USE 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. for more than 10 days unless directed by a doctor

📄 Ask a Doctor Before Use If 28 words ▾

ASK DOCTOR Ask a doctor before use if you have liver disease thyroid disease diabetes high blood pressure heart disease trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 18 words ▾

ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 When Using This Product 11 words ▾

WHEN USING When using this product do not exceed recommended dosage.

📄 Stop Use and Ask a Doctor If 52 words ▾

STOP USE Stop use and ask a doctor if you get nervous, dizzy, or sleepless 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 appear These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 14 words ▾

PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 52 words ▾

KEEP OUT OF REACH OF CHILDREN 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.

📄 Other Information 28 words ▾

OTHER SAFETY INFORMATION Other information store at room temperature 59º-86ºF (15º-30ºC) tamper evident sealed packets do not use any opened or torn packets avoid excessive heat and humidity

📄 Questions or Comments 6 words ▾

QUESTIONS Questions or comments? (888) 602-0288

📄 Package Label / Principal Display Panel 39 words ▾

PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label ProvisionPlus Sinu-Phen Plus Sinus Pain & Pressure Relief Fast Relief of: Fever Nasal Congestion Body Aches Sinus Pain 250 tablets 2 Per Packet PRINCIPAL DISPLAY PANEL – 250 Tablet Box 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 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Diarrhoea7
Vomiting7
Anxiety6
Insomnia6
Nausea6
Covid-195
Fatigue5

Age at onset

Adult3
Elderly1

Reporter sex

68 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization19
Life-threatening4
Disabling2
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 4 1
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

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 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 Wildman Business Group. 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 250 tablets (84269-2546-02). 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?
Wildman Business Group 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.
← 84269-2533-01 · Wildman 84269-2550-02 · Wildman →
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.