NDC 00363-0049-15 — Fexofenadine HCl and Pseudoephedrine 180 mg;

🆔 Identity & classification

FDA NDC (as labeled) 0363-0049-15

Product NDC 0363-0049

11-digit billing NDC 00363004915

NCPDP billing unit EA — each (per item)

RxCUI 997415

UNII 2S068B75ZU, 6V9V2RYJ8N

Application # ANDA079043

SPL Set ID acc07840-a892-a3f4-331d-a211b10842df

Established class (EPC) Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist

Mechanism of action Adrenergic alpha-Agonists; Histamine H1 Receptor Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Aug 2026)

Marketing start 2022-07-13

Marketing end 2026-08-30

Route ORAL

Dosage form TABLET, EXTENDED RELEASE

Substance FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

GCN Seq No 058869

GCN 24394

HICL code 016846

Ingredient (HICL) Fexofenadine/Pseudoephedrine

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z2

Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants

HIC3 code Z2O

Therapeutic class — specific (HIC3) 2Nd Gen Antihistamine And Decongestant Combination

AHFS code 04:08.00.00

AHFS class Second Generation Antihistamines

FDB label name ALLERGY RELIEF D24 180-240 MG

FDB brand name Allergy Relief D24

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 0363-0049-15 — 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 → 00363-0049-15. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist

Drug family (ATC) Other antihistamines for systemic use

How it works Histamine H1 Receptor Antagonists

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

LabelerWalgreens company

Application holderDR REDDYS LABORATORIES LTD

FDA applicationANDA079043 (ANDA)

Labeler code00363

First marketedJul 2022

Product typeHuman Otc Drug

Portfolio61 products on file

🔎 All NDCs from Walgreens company

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 ALLERGY RELIEF D24 180-240 MG Ingredient Fexofenadine/Pseudoephedrine

📗 Our plain-language guide HelloPharmacist

It's a two-in-one product. Fexofenadine is an antihistamine that helps with allergy symptoms like sneezing, runny nose, and itchy, watery eyes. Pseudoephedrine is a decongestant th...
What does this medicine actually do — why does it have two ingredients?
Actually, no — you should avoid fruit juices when taking this medication. Take it with a plain glass of water on an empty stomach. This is important for making sure your body absor...
Can I take this with my morning orange juice?

📖 Read our full Fexofenadine and Pseudoephedrine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

Try another pack size: 5 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mgthis 00363-0049-15	Walgreens	5 tablets	—	—	Discontinued	—
Allegra-D Allergy and Congestion 180 mg/1; 240 mg 41167-4320-05	Chattem,	5 tablets	—	—	FDA listed	—
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mg 43598-0892-07	Dr.Reddy's	5 tablets	—	—	Discontinued	—
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mg 51316-0018-10	CVS	5 tablets	—	—	Discontinued	—
Fexofenadine HCl and Pseudoephedrine HCI 180 mg/1; 240 mg 55111-0557-07	Dr.Reddy's	5 tablets	—	—	FDA listed	—
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 180 mg/1; 240 mg 58602-0844-60	Aurohealth	5 tablets	—	—	FDA listed	—
Fexofenadine HCl and Pseudoephedrine HCl 180 mg/1; 240 mg 79903-0255-10	Walmart	5 tablets	—	—	Discontinued	—

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

🏛️

2022

On the market since

Jul 2022

📍

2026

Currently FDA-listed

4 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.

🔬 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 Fexofenadine HCl and Pseudoephedrine HCl — the ingredient across all brands.

Top reported reactions

Completed Suicide4

Drug Interaction3

Acute Myocardial Infarction2

Diarrhoea2

Drug Toxicity2

Dyspnoea2

Fall2

Age at onset

Adult3

Reporter sex

Male · 56%

Female · 44%

Serious outcomes

Hospitalization7

Death7

Life-threatening1

Disabling1

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
00363-0049-10	2 BLISTER PACK in 1 CARTON (0363-0049-10) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2022-07-13	Active
00363-0049-15 You're viewing this	3 BLISTER PACK in 1 CARTON (0363-0049-15) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2022-07-13	Discontinued by firm

Pack size FAQ

What quantity is in NDC 00363-0049-15?

NDC 00363-0049-15 is listed by the FDA — 3 blister pack in 1 carton / 5 tablet, extended release in 1 blister pack.

What NDC number is used to bill for this package of Fexofenadine HCl and Pseudoephedrine 180 mg; 240 mg Tablet, Extended Release?

Bill NDC 00363-0049-15 — the 11-digit billing format is 00363004915. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

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 0363-0049-15, 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: 00363-0049-15, written without dashes as 00363004915. 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 00363-0049-15, the first segment (00363) is the labeler code FDA assigned to Walgreens company; the middle segment (0049) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 5 tablets (00363-0049-10). 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?

Walgreens 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.

📄 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

🎯 Indications and Usage 60 words ▾

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 73 words ▾

Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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 difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease.

Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless 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.

🧪 Active Ingredient 12 words ▾

Active ingredient(s) Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 mg

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

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

🔗 Related NDC lookups

🧪 All Fexofenadine Hcl And Pseudoephedrine Hcl NDCsSame ingredient 🏭 All Walgreens labeler NDCsLabeler code 00363 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — 2Nd Gen Antihistamine And Decongestant Combination.

Cetirizine Hcl/Pseudoephedrine 00113-0147-62 Loratadine/Pseudoephedrine 00113-2007-60 Desloratadine/Pseudoephedrine 78206-0120-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.