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allergy d loratadine, pseudoephedrine sulfate 10 mg; 240 mg Tablet, Extended Release — NDC 0113-9004-22 (Billing 00113-9004-22)

by L. Perrigo Company · 15 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of allergy d loratadine, pseudoephedrine sulfate 10 mg; 240 mg Tablet, Extended Release from L. Perrigo Company, marketed since Oct 2025 and currently FDA-listed; retail pharmacies pay about $0.5535 per unit (NADAC). It is this product's only package size.

NDC 00113-9004-22
🏷️ FDA NDC (as labeled) 0113-9004-22 billing pads the labeler segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0113-9004-22
Product NDC 0113-9004
11-digit billing NDC 00113900422
NCPDP billing unit EA — each (per item)
RxCUI 1117562
UNII 7AJO3BO7QN, Y9DL7QPE6B
Application # ANDA075989
SPL Set ID 512f8f46-5c62-470d-b14a-93b86ec34ce8
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-03
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance LORATADINE; PSEUDOEPHEDRINE SULFATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43993002597520
GCN Seq No 027622
GCN 63577
HICL code 006605
Ingredient (HICL) Loratadine/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 D-24HR 10-240 MG TAB
FDB brand name Allergy D-24 Hour
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 027622
  • GCN: 63577
  • GPI-14 (Medi-Span): 43993002597520
  • HICL (First Databank): 006605
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1117562
Why two NDCs? The FDA registers this code as 0113-9004-22 — 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 → 00113-9004-22. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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

Label name ALLERGY D-24HR 10-240 MG TAB Ingredient Loratadine/Pseudoephedrine
📖 What it is MedlinePlus · NLM

Loratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Loratadine 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.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves allergy symptoms like sneezing, runny nose, itchy, watery eyes, and itching of the nose or throat. It also relieves nasal and sinus congestion from allergie...
  • Swallow the tablet whole with a full glass of water. Never split, crush, chew or dissolve it. Some products are once a day and others are every 12 hours, so check your box and foll...
  • Not if it is an MAOI, or if you stopped one within the last 2 weeks. MAOIs are used for certain depression, psychiatric conditions, and Parkinson's disease. If you are unsure, ask...
  • Taking more than directed may cause drowsiness. Nervousness, dizziness or trouble sleeping can happen too. If any of these occur, stop and talk with your doctor.
📖 Read our full Loratadine / Pseudoephedrine guide →

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 eaPer package
Retail pharmacies payNADAC · weekly $0.554 $8.30 / 15 tablet
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.
NADAC price history (per ea) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Sep 2026 $0.585 $0.554
▼ Down 5% over the last 5 months.
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
00113-9004-22 You're viewing this Main listing 15 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2025-10-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
allergy d 10 mg/1; 240 mgthis 00113-9004-22 L. 1 tablet $0.553 — Availability likely —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 00904-5833-15 Major 10 tablets $0.553 — Availability likely —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 46122-0167-52 Amerisource 10 tablets $0.553 — Availability likely —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 46122-0383-22 AMERISOURCE 15 tablets $0.553 — Availability likely —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 51660-0724-04 Ohm 5 tablets $0.553 — Availability likely —
Leader Allergy Relief D-24 10 mg/1; 240 mg 70000-0162-01 Cardinal 10 tablets $0.553 — Availability likely —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 70677-1018-01 STRATEGIC 10 tablets $0.553 — Availability likely —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 49348-0543-01 STRATEGIC 10 tablets $0.574 — FDA listed +4%
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 62011-0071-01 Strategic 10 tablets $0.574 — FDA listed +4%
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 00363-0725-15 Walgreen 15 tablets — — FDA listed —
Allergy Relief D 10 mg/1; 240 mg 00363-2010-22 Walgreen 1 tablet — — FDA listed —
Claritin-D 24 Hour 10 mg/1; 240 mg 11523-0102-01 Bayer 10 tablets — — FDA listed —
Claritin-D 24 Hour 10 mg/1; 240 mg 11523-4332-01 Bayer 5 tablets — — Discontinued —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 11822-9990-00 Rite 10 tablets — — FDA listed —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 21130-0724-15 Safeway 15 tablets — — FDA listed —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 30142-0724-15 The 1 tablet — — FDA listed —
allergy congestion relief 10 mg/1; 240 mg 30142-0846-22 Kroger 1 tablet — — FDA listed —
topcare allergy and congestion relief 10 mg/1; 240 mg 36800-0706-22 Topco 1 tablet — — FDA listed —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 37808-0427-69 HEB 10 tablets — — FDA listed —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 37808-0724-69 HEB 10 tablets — — FDA listed —
Allergy Relief-D 240 mg/1; 10 mg 37808-0787-07 HEB 5 tablets — — FDA listed —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 41250-0724-52 Meijer 15 tablets — — FDA listed —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 49035-0488-15 WAL-MART 15 tablets — — FDA listed —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 51660-0491-15 Ohm 15 tablets — — Discontinued —
Loratadine and Pseudoephedrine Sulfate 10 mg/1; 240 mg 56062-0724-15 Publix 15 tablets — — FDA listed —
Allergy Relief-D 10 mg/1; 240 mg 59779-0726-15 CVS 5 tablets — — FDA listed —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 63187-0305-10 Proficient 10 tablets — — FDA listed —
kirkland signature allerclear d 24 hr 10 mg/1; 240 mg 63981-0138-22 Costco 1 tablet — — FDA listed —
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release 10 mg/1; 240 mg 63981-0724-15 Kirkland-COSTCO 15 tablets — — FDA listed —
Loratadine and Pseudoephedrine 10 mg/1; 240 mg 85766-0048-10 Sportpharm 10 tablets — — 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

Manufacturer & labeler

LabelerL. Perrigo Company
Application holderPERRIGO PHARMA INTERNATIONAL DAC
FDA applicationANDA075989 (ANDA)
Labeler code00113
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio228 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.

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: • sneezing • itchy, watery eyes • runny nose • 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 53 words ▾

Directions • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings 207 words ▾

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

Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness.

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 • nervousness, dizziness or sleeplessness occurs 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 12 words ▾

Active ingredients (in each tablet) Loratadine 10 mg Pseudoephedrine sulfate 240 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

📄 Do Not Use 73 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.

📄 Ask a Doctor Before Use If 44 words ▾

Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose.

📄 When Using This Product 17 words ▾

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

📄 Stop Use and Ask a Doctor If 40 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 • nervousness, dizziness or sleeplessness occurs

🤰 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 29 words ▾

Other information • do not use if printed blister unit is broken or torn • store between 20°-25°C (68°-77°F) • protect from light and store in a dry place

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 77 words ▾

Package/Label Principal Display Panel Compare to Claritin-D ® 24 Hour active ingredients ALLERGY & CONGESTION allergy-D Pseudoephedrine Sulfate 240 mg/Nasal Decongestant Loratadine 10 mg/Antihistamine Extended-Release Tablets INDOOR & OUTDOOR ALLERGIES 24 Hour Relief of: • Nasal and Sinus Congestion Due to Cold or Allergies • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy, Throat or Nose Due to Allergies *Non-Drowsy *When taken as directed. See Drug Facts Panel. Actual Size 15 EXTENDED RELEASE TABLETS 2d8-55-allergy-d.jpg

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 allergy d (this brand).

Top reported reactions

Dyspnoea3
Cough2
Asthma1
Autoimmune Disorder1
Blood Pressure Abnormal1
Condition Aggravated1
Depressed Mood1

Reporter sex

5 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1 0
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 — 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) ✓ Available
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 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 L. Perrigo Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
L. Perrigo 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.
← 00113-8959-26 · L. 00113-9458-13 · L. →
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.