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Rugby Allergy Relief D fexofenadine hydrochloride, pseudoephedrine hydrochloride 60 mg; 120 mg Tablet, Film Coated, Extended Release — NDC 0536-1491-34 (Billing 00536-1491-34)

by Rugby Laboratories · 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of Rugby Allergy Relief D fexofenadine hydrochloride, pseudoephedrine hydrochloride 60 mg; 120 mg Tablet, Film Coated, Extended Release from Rugby Laboratories, marketed since Jul 2026 and currently FDA-listed.

NDC 00536-1491-34
🏷️ FDA NDC (as labeled) 0536-1491-34 billing pads the labeler segment with a zero
This package
Contains1 tablet, film coated, extended release in 1 blister pack Pack sizes2 compare ↓
Product page 00536-1491-07 Also comes in: 1 tablet 0536-1491-07
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 0536-1491-34 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1491 product · 34 package
Package marketed since
Jul 8, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0536149134 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1491-34
Product NDC 0536-1491
11-digit billing NDC 00536149134
RxCUI 997406
UNII 2S068B75ZU, 6V9V2RYJ8N
Application # ANDA216792
SPL Set ID 35f93439-eed1-40f4-a792-7527fbf3c19a
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 On market
FDA listing status Listed (active directory)
Marketing start 2026-07-08
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 997406
Why two NDCs? The FDA registers this code as 0536-1491-34 — 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 → 00536-1491-34. 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.

Clinical

📖 What it is MedlinePlus · NLM

The combination of fexofenadine and pseudoephedrine is used to treat allergy or cold symptoms: runny nose sneezing congestion (stuffy nose, sinus pressure) red, itchy, or watery eyes itching of the nose, throat, or roof of the mouth Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms. Pseudoephedrine is in a class of medications called decongestants. It works by causing narrowing of the blood vessels in the nasal passages to relieve congestion.

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.
Try another pack size: 1 tablet
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
00536-1491-07 0536-1491-07 Main listing 30 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2026-07-08 — Active
00536-1491-34 You're viewing this 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2026-07-08 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack.
What NDC number is used to bill for this package of Rugby Allergy Relief D fexofenadine hydrochloride, pseudoephedrine hydrochloride 60 mg; 120 mg Tablet, Film Coated, Extended Release?
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
Foster And Thrive Allergy And Congestion D 60 mg/1; 120 mg 70677-1315-01 Strategic 1 tablet — — FDA listed —
Rugby Allergy Relief D 60 mg/1; 120 mgthis 00536-1491-34 Rugby 1 tablet — — FDA listed —
Leader 12Hr Allergy And Congestion Relief 60 mg/1; 120 mg 70000-0772-01 Cardinal 1 tablet — — FDA listed —
Equate Allergy Relief D 60 mg/1; 120 mg 79903-0424-20 WALMART 1 tablet — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 Yellow / White
ShapeOval
Imprint5U0
Size18 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • 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 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.

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

The official label also statescolloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

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

LabelerRugby Laboratories
Application holderL PERRIGO CO
FDA applicationANDA216792 (ANDA)
Labeler code00536
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio149 products on file

More NDCs from Rugby Laboratories labeler code 00536

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 📄 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 69 words ▾

Uses • 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 74 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 12 hours on an empty stomach; do not take more than 2 tablets 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 a 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 (1-800-222-1222).

🧪 Active Ingredient 13 words ▾

Active ingredients (in each tablet) Fexofenadine HCl 60 mg Pseudoephedrine HCl 120 mg

🧪 Inactive Ingredients 37 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

📄 Do Not Use 79 words ▾

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 44 words ▾

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 53 words ▾

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 a Doctor If 41 words ▾

Stop use and ask a 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 10 words ▾

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

📄 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 (1-800-222-1222).

📄 Other Information 43 words ▾

Other information • each tablet contains: calcium 21 mg • safety sealed: do not use if carton is opened or if individual blister units are torn or opened • store between 20° and 25°C (68° and 77°F) • meets USP Dissolution Test 2

📄 Questions or Comments 3 words ▾

Questions or comments?

📄 Package Label / Principal Display Panel 73 words ▾

Package/Label Principal Display Panel Rugby® compare to the active ingredients in Allegra-D® Allergy & Congestion non-drowsy allergy relief D fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg extended release tablets antihistamine/nasal decongestant 12 HR allergy & congestion indoor/outdoor relief of • nasal and sinus congestion due to colds or allergies • sneezing; runny nose; itchy, watery eyes and itchy nose or throat due to allergies 20 extended release tablets actual size rugby-allergy-relief-d-carton-image.jpg

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
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) ✓ 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 Rugby Laboratories. 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 1 tablet (00536-1491-07). 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?
Rugby Laboratories 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.
← 00536-1489-20 · Rugby 00536-1962-97 · Rugby →
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.