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Pseudoephedrine HCl 120 mg Tablet, Extended Release, 10-count — NDC 58602-0804-83 package photo

Pseudoephedrine HCl 120 mg Tablet, Extended Release, 10-count

by Aurohealth LLC · 1 BLISTER PACK in 1 CARTON (58602-804-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 58602-0804-83
🏷️ FDA NDC (as labeled) 58602-804-83 billing pads the product segment with a zero
This package
Contains10-count Pack sizes2 compare ↓
Also comes in: 10 tablets 58602-0804-67
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 58602-804-83
Product NDC 58602-804
11-digit billing NDC 58602080483
RxCUI 1049154
UNII 6V9V2RYJ8N
Application # ANDA209008
SPL Set ID 1056d9da-8a3f-4b7a-878e-7f8d45d298cd
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 2017-06-09
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 58602-804-83 — 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 → 58602-0804-83. 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

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA209008 (ANDA)
Labeler code58602
First marketedJun 2017
Product typeHuman Otc Drug
Portfolio174 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?
📖 Read our full 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.

💊 What it looks like

Color White
ShapeCapsule
Imprint70;T
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 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 UKE75GEA7F
    Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
  • UNII Z78RG6M2N2
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material in tablets and capsules. It helps hold ingredients together and creates a protective coating that controls how quickly the medicine dissolves.
  • UNII 39J80LT57T
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in 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 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statescolloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, 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 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: 10 tablets
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pseudoephedrine Hydrochloride 120 mg 62011-0306-01 STRATEGIC 10 tablets $0.274 — FDA listed —
leader 12 hour nasal decongestant 120 mg 70000-0475-01 Cardinal 1 tablet $0.276 — FDA listed —
Good Sense Suphedrine 12 Hour 120 mg 00113-0054-52 L. 1 tablet $0.281 — Availability likely —
sinus 12 hour 120 mg 00113-2017-60 L. 1 tablet $0.281 — Availability likely —
SudoGest 12 Hour 120 mg 00904-6754-15 Major 1 tablet $0.281 — Availability likely —
Pseudoephedrine hydrochloride 120 mg 00904-7409-15 Major 10 tablets $0.281 — Availability likely —
good neighbor pharmacy nasal decongestant 120 mg 24385-0054-52 Amerisource 1 tablet $0.281 — Availability likely —
pseudoephedrine hydrochloride 120 mg 45802-0107-52 Padagis 1 tablet $0.281 — Availability likely —
Pseudoephedrine hydrochloride 120 mg 51660-0204-21 Ohm 20 tablets $0.281 — Availability likely —
Pseudoephedrine hydrochloride 120 mg 51660-0492-21 Ohm 20 tablets $0.281 — Availability likely —
Pseudoephedrine Hydrochloride 120 mg 70000-0601-01 CARDINAL 20 tablets $0.281 — Availability likely —
12 Hour Nasal Decongestant 120 mg 70000-0656-01 CARDINAL 10 tablets $0.281 — Availability likely —
nasal decongestant 120 mg 70677-0001-01 Strategic 10 tablets $0.281 — Availability likely —
Pseudoephedrine hydrochloride 120 mg 70677-1019-01 STRATEGIC 10 tablets $0.281 — Availability likely —
Nasal Decongestant D 120 mg 00363-3301-52 Walgreen 1 tablet — — FDA listed —
sinus pressure and congestion relief maximum strength 120 mg 11822-0650-06 Rite 1 tablet — — FDA listed —
Pseudoephedrine HCl 120 mg 21130-0158-67 Better 10 tablets — — FDA listed —
Pseudoephedrine Hydrochloride 120 mg 21130-0204-21 Safeway 20 tablets — — FDA listed —
Pseudoephedrine hydrochloride 120 mg 30142-0967-20 The 20 tablets — — FDA listed —
topcare 12 hour decongestant 120 mg 36800-0054-52 Topco 1 tablet — — FDA listed —
Pseudoephedrine Hydrochloride 120 mg 37808-0007-69 HEB 20 tablets — — FDA listed —
Equaline 12 Hour Decongestant 120 mg 41163-0054-60 United 1 tablet — — FDA listed —
nasal decongestant 120 mg 41250-0809-52 Meijer 1 tablet — — FDA listed —
CareOne Nasal and Sinus Decongestant 120 mg 41520-0429-52 American 1 tablet — — FDA listed —
equate sinus 12 hour 120 mg 49035-0508-60 Wal-Mart 1 tablet — — FDA listed —
Sudafed Sinus Congestion 12 Hour 120 mg 50090-4629-00 A-S 10 tablets — — FDA listed —
Pseudoephedrine hydrochloride 120 mg 50090-5554-00 A-S 10 tablets — — FDA listed —
Sudafed Sinus Congestion 12 Hour 120 mg 50580-0242-01 Kenvue 10 tablets — — FDA listed —
sinus and nasal decongestant 120 mg 51316-0616-52 CVS 1 tablet — — FDA listed —
Pseudoephedrine hydrochloride 120 mg 53943-0204-10 DISCOUNT 10 tablets — — FDA listed —
nasal decongestant 120 mg 56062-0054-60 Publix 1 tablet — — FDA listed —
Pseudoephedrine Hydrochloride 120 mg 56062-0204-21 Publix 20 tablets — — FDA listed —
Pseudoephedrine HCl 120 mgthis 58602-0804-83 Aurohealth 10 tablets — — FDA listed —
Pseudoephedrine Hydrochloride 120 mg 59779-0204-21 CVS 20 tablets — — FDA listed —
12 Hour Nasal Decongestant 120 mg 59779-0703-52 CVS 1 tablet — — FDA listed —
Pseudoephedrine Hydrochloride 120 mg 63868-0143-10 Chain 10 tablets — — FDA listed —
Pseudoephedrine Hydrochloride 120 mg 68016-0204-69 Chain 10 tablets — — FDA listed —
Pseudoephedrine hydrochloride 120 mg 68196-0204-20 SAM'S 10 tablets — — FDA listed —
Leader 12 Hour Sinus Nasal Decongestant 120 mg 70000-0735-01 Cardinal 1 tablet — — FDA listed —
Pseudoephedrine hydrochloride 120 mg 85766-0050-10 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
Jun 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58602-0804-67 2 BLISTER PACK in 1 CARTON (58602-804-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2017-06-09 Active
58602-0804-83 You're viewing this 1 BLISTER PACK in 1 CARTON (58602-804-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2017-06-09 Active

Pack size FAQ

What quantity is in NDC 58602-0804-83?
NDC 58602-0804-83 is a 10-count package — 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack.
What NDC number is used to bill for this package of Pseudoephedrine HCl 120 mg Tablet, Extended Release?
Bill NDC 58602-0804-83 — the 11-digit billing format is 58602080483. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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

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 58602-804-83, 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: 58602-0804-83, written without dashes as 58602080483. 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 58602-0804-83, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0804) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (83) 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 Aurohealth LLC. 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 10 tablets (58602-0804-67). 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?
Aurohealth LLC 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 40 words ▾

Directions adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

⚠️ Warnings 1 words ▾

Warnings

📦 Storage and Handling 45 words ▾

Other information Each tablet contains: calcium 36 mg store at 20° to 25°C (68° to 77°F). Protect from light. do not use if the individual blister unit is open or torn see side panel for lot number and expiration date Meets USP dissolution test 4

🧪 Active Ingredient 10 words ▾

Active ingredient (in each tablet) Pseudoephedrine HCl USP 120 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

🎯 Purpose 3 words ▾

Purpose Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58602-0803-03 · Aurohealth 58602-0805-01 · Aurohealth →
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.