Nasal Decongestant Pseudoephedrine HCl 30 mg Tablet, 24-count
by Proficient Rx LP · 1 BLISTER PACK in 1 CARTON (63187-344-24) / 24 TABLET in 1 BLISTER PACK
NDC 63187-0344-24
🏷️ FDA NDC (as labeled)
63187-344-24
billing pads the product segment with a zero
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)
63187-344-24
Product NDC
63187-344
11-digit billing NDC
63187034424
RxCUI
1049160
UNII
6V9V2RYJ8N
Application #
M012
SPL Set ID
4eab4344-d95e-4b19-a21e-9c8ad033863a
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
2012-10-29
Route
ORAL
Dosage form
TABLET
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 63187-344-24 — a 5-3-2 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 product segment → 63187-0344-24. 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
LabelerProficient Rx LP
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63187
First marketedOct 2012
Product typeHuman Otc Drug
Portfolio1,729 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
📖 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.
💊 What it looks like
Color
Red
ShapeRound
Imprint1004
Size8 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.
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UNII 933ANU3H2S
12-Hydroxystearic acid is a fatty acid derived from plant or animal oils. It works as a thickener and emulsifier in medicines, helping blend ingredients together and give the product a smooth, stable texture.
-
UNII V38QUQ7861
A pollen extract from sugar maple plants used as a natural flavor or coloring agent in medicines. It may help mask taste or add subtle sweetness to make the medication more palatable.
-
UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
-
UNII WAT0DDB505
Calcium sulfate is a mineral compound used as a filler and binder in tablets and capsules. It helps give the medicine its solid structure and ensures consistent dosing.
-
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
-
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 WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII 24H4NWX5CO
Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
-
UNII 9B9691B2N9
Magnesium silicate is a mineral compound used in tablets and capsules as a glidant and anti-caking agent. It helps powder ingredients flow smoothly during manufacturing and prevents clumping in the final product.
-
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 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
-
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.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
16 inactive ingredients listed in the exact product block matched to this NDC.
The official label also states• calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide
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.
💲 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.
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 mg 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 mgthis 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
🏛️
2012
On the market since
Oct 2012
📍
2026
Currently FDA-listed
14 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.
🔬 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 nasal decongestant (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 12%
Female · 88%
Unknown · 0%
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 | Marketing start | Status |
|---|---|---|---|
| 63187-0344-24 You're viewing this | 1 BLISTER PACK in 1 CARTON (63187-344-24) / 24 TABLET in 1 BLISTER PACK | 2014-03-03 | Active |
🧭 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 | ✓ Available |
| 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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 FDA registers it as 63187-344-24, 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: 63187-0344-24, written without dashes as 63187034424. 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 63187-0344-24, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0344) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP 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 ▾
Use(s) • 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 adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 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
⚠️ 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 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • diabetes • high blood pressure • heart disease • thyroid disease • trouble urinating due to an enlarged prostate gland When using this product • do not use more than directed Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with 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).
🧪 Active Ingredient ▾
Active ingredient (in each tablet) • Pseudoephedrine HCl 30 mg
🧪 Inactive Ingredients ▾
Inactive ingredients • calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide
🎯 Purpose ▾
Purpose • Nasal Congestant
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.