Leader Allergy Relief D-24 Loratadine and Pseudoephedrine Sulfate 10 mg; 240 mg Tablet, Film Coated, Extended Release, 15-count
by Cardinal Health · 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-2)
NDC 70000-0162-02
🏷️ FDA NDC (as labeled)
70000-0162-2
billing pads the package segment with a zero
This package
Also priced by: Medicaid pays $0.8326/unit — full pricing hub ↓
Also comes in:
10 tablets 70000-0162-01
OTC
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
70000-0162-2
Product NDC
70000-0162
11-digit billing NDC
70000016202
NCPDP billing unit
EA — each (per item)
RxCUI
1117562
UNII
7AJO3BO7QN, Y9DL7QPE6B
Application #
ANDA076557
SPL Set ID
f1bcd2aa-e8cd-4364-87b4-c544537cdb50
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
2017-02-15
Route
ORAL
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
GPI-14
43993002597520
GPI class
Allergy Relief D-24
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 RELIEF D-24HR TABLET
FDB brand name
Allergy Relief D-24Hr
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0162-2 — 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 → 70000-0162-02. 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.
🏭 Manufacturer & labeler
LabelerCardinal Health
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA076557 (ANDA)
Labeler code70000
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio84 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.
🩺 Clinical
Label name ALLERGY RELIEF D-24HR TABLET Ingredient Loratadine/Pseudoephedrine
📗 Our plain-language guide HelloPharmacist
- Great question. The two ingredients each do something different. Loratadine is an antihistamine — it targets the sneezing, runny nose, itchy eyes, and throat itching that come with...
- What exactly does this medicine do, and why does it have two ingredients?
- You take it by mouth with a full glass of water — but it's really important that you swallow it whole. Do not crush, split, chew, or dissolve it. These are extended-release tablets...
- How do I take it, and does it matter if I crush or split the tablet?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Loratadine and Pseudoephedrine Sulfate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.554 | $8.30 / 15 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.8326 | $12.49 / 15 tablets |
| 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
▲ Up 9% over the last 24 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| allergy d 10 mg/1; 240 mg 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 mgthis 70000-0162-02 | Cardinal | 15 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
🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0162-02, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.3K
Units reimbursed last 4 qtrs
67.3K
Gross reimbursed last 4 qtrs
$56K
Avg / prescription
$23.96
Avg / unit
$0.8326
Latest quarter Q4 2025
404Rx
Medicaid pays / ea
$0.8326
gross reimbursed
vs
NADAC / ea
$0.5535
acquisition cost
=
Spread
+$0.2791
+50% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 1,332 Rx Managed care · 1,005 Rx
State Medicaid map
Units reimbursed · per 100k residents
11.2155
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 2,988 Rx · 83,558 units · $69,669 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 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 Leader Allergy Relief D-24 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 32%
Female · 68%
Serious outcomes
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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 70000-0162-01 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-1) | $0.5535 / ea | $5.53 | 2020-01-15 | Active |
| 70000-0162-02 You're viewing this | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-2) | $0.5535 / ea | $8.30 | 2020-01-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.5535 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 78% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 70000-0162-02?
NDC 70000-0162-02 is a 15-count package — 15 tablet, film coated, extended release in 1 blister pack.
What is the difference between NDC 70000-0162-02 and NDC 70000-0162-01?
Both are Leader Allergy Relief D-24 Loratadine and Pseudoephedrine Sulfate 10 mg; 240 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 70000-0162-02 is the 15-count package, while NDC 70000-0162-01 is the 10 tablets package.
What NDC number is used to bill for this package of Leader Allergy Relief D-24 Loratadine and Pseudoephedrine Sulfate 10 mg; 240 mg Tablet, Film Coated, Extended Release?
Bill NDC 70000-0162-02 — the 11-digit billing format is 70000016202. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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 ▾
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 ■ reduces swelling of nasal passages ■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ temporarily restores freer breathing through the nose
⏱️ Dosage and Administration ▾
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 ▾
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 ▾
Active ingredients Loratadine, USP 10 mg Pseudoephedrine Sulfate, USP 240 mg
🧪 Inactive Ingredients ▾
InactiveIngredients calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
🎯 Purpose ▾
Purpose Antihistamine Nasal Decongestant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.