Leader Nasal Decongestant Pseudoephedrine HCl 30 mg Tablet, Film Coated
by Cardinal Health 110, LLC. dba Leader · 24 BLISTER PACK in 1 CARTON (70000-0002-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC 70000-0002-01
🏷️ FDA NDC (as labeled)
70000-0002-1
billing pads the package segment with a zero
This package
Contains1 tablet, film coated in 1 blister pack
Cost per ea$0.0776 NADAC
Per package$1.86 / 24 tablet
Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3091/unit — full pricing hub ↓
Also comes in:
12 tablets 70000-0002-02
OTC
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)
70000-0002-1
Product NDC
70000-0002
11-digit billing NDC
70000000201
NCPDP billing unit
EA — each (per item)
RxCUI
1049160
UNII
6V9V2RYJ8N
Application #
M012
SPL Set ID
25609b66-047c-46e7-bc95-20eb8e6c9617
Established class (EPC)
alpha-Adrenergic Agonist
Mechanism of action
Adrenergic alpha-Agonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-12-20
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
GPI-14
42101020100305
GPI class
Nasal Decongestant
GCN Seq No
005089
GCN
20481
HICL code
002091
Ingredient (HICL)
Pseudoephedrine Hcl
HIC1 code
B
Therapeutic class — broad (HIC1)
Respiratory System
HIC2 code
B6
Therapeutic class — intermediate (HIC2)
Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code
B6V
Therapeutic class — specific (HIC3)
Decongestants, Oral
AHFS code
12:12.12.00
AHFS class
Alpha- And Beta-Adrenergic Agonists
FDB label name
NASAL DECONGESTANT 30 MG TAB
FDB brand name
Nasal Decongestant
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0002-1 — 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 → 70000-0002-01. 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-Adrenergic Agonist class.
Pharmacologic class
alpha-Adrenergic Agonist
Drug family (ATC)
Sympathomimetics
How it works
Adrenergic alpha-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.
🏭 Manufacturer & labeler
LabelerCardinal Health 110, LLC. dba Leader
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedDec 2019
Product typeHuman Otc Drug
Portfolio163 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 NASAL DECONGESTANT 30 MG TAB Ingredient Pseudoephedrine Hcl
📖 What it is MedlinePlus · NLM
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Pseudoephedrine is a decongestant — it works to temporarily shrink the swollen blood vessels inside your nasal passages and sinuses, which helps open things up so you can breathe m...
- What exactly does pseudoephedrine do for my congestion?
- Yes, it does. The regular tablets and Zephrex D capsules are taken every 4 to 6 hours, while extended-release tablets like Sudafed Sinus Congestion 12 Hour or Good Sense Suphedrine...
- Does it matter which product or form I pick?
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 Pseudoephedrine HCl?
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 | $0.078 | $1.86 / 24 tablet |
| Medicaid paysCMS SDUD · 12 mo | $0.3091 | $7.42 / 24 tablet |
| 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 52% 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 |
|---|---|---|---|---|---|---|
| Good Sense Nasal Decongestant 30 mg 00113-0432-62 | L. | 24 tablets | $0.078 | — | Availability likely | — |
| Nasal Decongestant 30 mg 00536-3607-35 | Rugby | 24 tablets | $0.078 | — | Availability likely | — |
| SudoGest 30 mg 00904-5053-59 | Major | 100 tablets | $0.078 | — | Availability likely | — |
| SudoGest Nasal Decongestant 30 mg 00904-6337-24 | Major | 1 tablet | $0.078 | — | Availability likely | — |
| SudoGest 30 mg 00904-6727-60 | Major | 100 tablets | $0.078 | — | Availability likely | — |
| Pseudoephedrine HCl 30 mg 00904-6990-61 | Major | 10 tablets | $0.078 | — | Availability likely | — |
| pseudoephedrine hydrochloride 30 mg 45802-0432-62 | Padagis | 1 tablet | $0.078 | — | Availability likely | — |
| Nasal Decongestant Maximum Strength, Non-Drowsy 30 mg 46122-0428-62 | Amerisource | 24 tablets | $0.078 | — | Availability likely | — |
| Leader Nasal Decongestant 30 mgthis 70000-0002-01 | Cardinal | 1 tablet | $0.078 | — | Availability likely | — |
| Nasal Decongestant Maximum Strength 30 mg 70677-1017-01 | Strategic | 24 tablets | $0.078 | — | Availability likely | — |
| Nasal Decongestant D 30 mg 00363-1214-08 | Walgreen | 24 tablets | — | — | FDA listed | — |
| Sinus Pressure and Congestion Relief Maximum Strength 30 mg 11822-0112-02 | Rite | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Maximum Strength 30 mg 21130-0112-08 | Better | 24 tablets | — | — | FDA listed | — |
| sinus 30 mg 30142-0613-62 | Kroger | 1 tablet | — | — | Discontinued | — |
| Sinus Decongestion 30 mg 30142-0641-08 | Kroger | 24 tablets | — | — | FDA listed | — |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy 30 mg 36800-0432-62 | Topco | 1 tablet | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 37808-0112-22 | H | 24 tablets | — | — | FDA listed | — |
| equaline nasal decongestant non drowsy maximum strength 30 mg 41163-0432-67 | United | 6 tablets | — | — | FDA listed | — |
| nasal decongestant maximum strength non drowsy 30 mg 41250-0432-62 | Meijer | 1 tablet | — | — | FDA listed | — |
| CareOne Nasal and Sinus Decongestant 30 mg 41520-0881-62 | American | 12 tablets | — | — | FDA listed | — |
| Sinus and Congestion Non-Drowsy 30 mg 49035-0780-08 | Wal-Mart | 24 tablets | — | — | FDA listed | — |
| Sudogest 30 mg 50090-1961-00 | A-S | 28 tablets | — | — | FDA listed | — |
| Sudogest Nasal Decongestant 30 mg 50090-4345-00 | A-S | 48 tablets | — | — | Discontinued | — |
| pseudoephedrine hydrochloride 30 mg 50090-5615-01 | A-S | 1 tablet | — | — | FDA listed | — |
| SUDAFED Sinus Congestion 30 mg 50580-0363-01 | Kenvue | 12 tablets | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 50844-0112-08 | L.N.K. | 12 tablets | — | — | FDA listed | — |
| Sinus and Nasal Decongestant 30 mg 51316-0121-22 | CVS | 24 tablets | — | — | FDA listed | — |
| Sinus And Nasal Decongestant 30 mg 51316-0317-62 | CVS | 12 tablets | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 56062-0432-62 | Publix | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Non-Drowsy 30 mg 59779-0112-08 | CVS | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 59779-0432-62 | CVS | 1 tablet | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 63187-0344-24 | Proficient | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Maximum Strength 30 mg 63868-0802-24 | CHAIN | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Maximum Strength 30 mg 68016-0473-24 | Chain | 24 tablets | — | — | FDA listed | — |
| pseudoephedrine hydrochloride 30 mg 71205-0197-24 | Proficient | 1 tablet | — | — | FDA listed | — |
| Sinus Congestion 30 mg 83324-0054-24 | Chain | 24 tablets | — | — | FDA listed | — |
| pseudoephedrine hydrochloride 30 mg 85766-0049-24 | Sportpharm | 1 tablet | — | — | 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
🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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.
🗺️ 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 70000-0002-01, 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 – Q1 2026 · 5 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
761
Units reimbursed last 4 qtrs
21.1K
Gross reimbursed last 4 qtrs
$6.5K
Avg / prescription
$8.58
Avg / unit
$0.3091
Latest quarter Q1 2026
282Rx
Medicaid pays / ea
$0.3091
gross reimbursed
vs
NADAC / ea
$0.0776
acquisition cost
=
Spread
+$0.2315
+298% 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 · 182 Rx Managed care · 579 Rx
State Medicaid map
Units reimbursed · per 100k residents
6.469.9
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): 1,194 Rx · 36,746 units · $10,818 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 Nasal Decongestant (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 40%
Female · 59%
Unknown · 2%
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 |
|---|---|---|---|---|---|
| 70000-0002-01 You're viewing this | 24 BLISTER PACK in 1 CARTON (70000-0002-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK | $0.0776 / ea | $1.86 | 2019-12-20 | Active |
| 70000-0002-02 | 8 BLISTER PACK in 1 CARTON (70000-0002-2) / 12 TABLET, FILM COATED in 1 BLISTER PACK | $0.0776 / ea | $7.45 | 2020-01-16 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0776 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 64% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 70000-0002-01?
NDC 70000-0002-01 is listed by the FDA — 24 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Leader Nasal Decongestant Pseudoephedrine HCl 30 mg Tablet, Film Coated?
Bill NDC 70000-0002-01 — the 11-digit billing format is 70000000201. 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
⏱️ Dosage and Administration ▾
Directions adults and children 12 years and over • take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 years • take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age
⚠️ Warnings ▾
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. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever 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).
📦 Storage and Handling ▾
Other information • each tablet contains: calcium 20 mg • store at 20 ° -25 ° C (68 ° -77 ° F) • do not use if blister unit is broken or torn
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg
🧪 Inactive Ingredients ▾
Inactive ingredients carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide
🎯 Purpose ▾
Purpose 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.