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Sinus PE Congestion Diphenhydramine HCl, Phenylephrine HCl Kit — NDC 00363-4534-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sinus PE Congestion Diphenhydramine HCl, Phenylephrine HCl Kit — NDC 0363-4534-09 (Billing 00363-4534-09)

by Walgreen Company · 1 KIT in 1 PACKAGE, COMBINATION * 12 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Sinus PE Congestion Diphenhydramine HCl, Phenylephrine HCl Kit from Walgreen Company, marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 00363-4534-09
🏷️ FDA NDC (as labeled) 0363-4534-09 billing pads the labeler segment with a zero
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 0363-4534-09 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0363 labeler · 4534 product · 09 package
Package marketed since
Jan 19, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0363453409 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-4534-09
Product NDC 0363-4534
11-digit billing NDC 00363453409
RxCUI 1049182, 1052928, 2639176
Application # M012
SPL Set ID 5b9151b7-3e40-4f37-b3e0-4c0fa0115b71
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-19
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1049182
Why two NDCs? The FDA registers this code as 0363-4534-09 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00363-4534-09. 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 alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists
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

📖 About the active ingredient: Diphenhydramine HCl, Phenylephrine HCl MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter kit product containing two active ingredients commonly used to relieve sinus congestion. Phenylephrine hydrochloride functions as a nasal decongestant that works to reduce swelling in the nasal passages, while diphenhydramine hydrochloride is an antihistamine typically used to help relieve allergy symptoms and reduce congestion-related discomfort. The kit format allows the two ingredients to be used together as part of a sinus relief regimen.

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
00363-4534-09 You're viewing this Main listing 1 KIT in 1 PACKAGE, COMBINATION * 12 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK 2022-01-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sinus PE Congestion Daytime Nighttime 79481-4534-01 Meijer 12 tablets — — FDA listed —
Sinus PE Congestionthis 00363-4534-09 Walgreen 12 tablets — — FDA listed —
Sinus Pressure and Congestion Relief 11822-9485-09 Rite 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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 red / blue
ShapeOval
Imprint44;485
Size11 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.

From the label’s inactive-ingredient sectioncroscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

Manufacturer & labeler

LabelerWalgreen Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio468 products on file

More NDCs from Walgreen Company labeler code 00363

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 📦 Storage and Handling 🧪 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sneezing (Nighttime only) runny nose (Nighttime only) itchy, watery eyes (Nighttime only) itching of the nose or throat (Nighttime only) temporarily relieves these symptoms due to the common cold: nasal congestion sneezing (Nighttime only) runny nose (Nighttime only) temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years: do not use

⚠️ Warnings ~1 min read ▾

Warnings Do not use 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. with any other product containing diphenhydramine, even one used on skin (Nighttime only) Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

(Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur If pregnant or breast-feeding, ask a health professional before use.

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

Do not take DAYTIME and NIGHTTIME products at the same time.

📦 Storage and Handling 44 words ▾

Other information each tablet contains: calcium 25 mg (Nighttime only) 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 26 words ▾

Active ingredient (in each tablet) (Sinus Day) Phenylephrine HCl 10 mg

Active ingredients (in each tablet) (Sinus Night) Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 60 words ▾

Inactive ingredients (Daytime only) croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Inactive ingredients (Nighttime only) croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

🎯 Purpose 7 words ▾

Purpose Nasal decongestant

Purpose Antihistamine Nasal decongestant

📄 Do Not Use 68 words ▾

Do not use 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. with any other product containing diphenhydramine, even one used on skin (Nighttime only)

📄 Ask a Doctor Before Use If 40 words ▾

Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only)

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. (Nighttime only)

📄 When Using This Product 49 words ▾

When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only)

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop use and ask a doctor if symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 36 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

📄 Questions or Comments 9 words ▾

Questions or comments? 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

📄 Package Label / Principal Display Panel 188 words ▾

Principal display panel DAY & NIGHT PACK Walgreens • WALGREENS • PHARMACIST RECOMMENDED † Compare to the active ingredients in Sudafed PE ® Sinus Congestion Daytime + Nighttime †† DAYTIME • NON-DROWSY Sinus PE Congestion PHENYLEPHRINE HCI 10 mg / NASAL DECONGESTANT Maximum Strength • Relieves sinus pressure & congestion • Pseudoephedrine free 12 TABLETS ACTUAL SIZE NIGHTTIME Sinus PE Congestion DIPHENHYDRAMINE HCl 25 mg / ANTIHISTAMINE PHENY LEPHRINE HCl 10 mg / NASAL DECONGESTANT • Relieves itchy, water eyes, runny nose & itchy throat • Pseudoephedrine free 8 TABLETS ACTUAL SIZE TOTAL 20 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Do not take the Daytime and Nighttime tablets at the same time. † Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands. †† This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Sudafed PE ® . 50844 REV0820A45348509 DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2025 Walgreen Co.

NDC 0363-4534-09 REV-0425 W3ORG1221-F Walgreens 44-453485 Walgreens 44-453485

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 Walgreen Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreen Company 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.
← 00363-4531-07 · Walgreen 00363-4545-01 · Walgreen →
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.