leader 12 hour nasal decongestant Pseudoephedrine Hydrochloride 120 mg Tablet, Film Coated, Extended Release — NDC 70000-0475-1 (Billing 70000-0475-01)
This is a package of leader 12 hour nasal decongestant Pseudoephedrine Hydrochloride 120 mg Tablet, Film Coated, Extended Release from Cardinal Health 110, LLC. dba Leader, marketed since Feb 2019 and currently FDA-listed, this package's marketing is listed to end Mar 2027; retail pharmacies pay about $0.2765 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70000-0475-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 70000 labeler · 0475 product · 1 package
- Package marketed since
- Feb 11, 2019
- Package marketing ended
- Mar 31, 2027
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 7000004751 1
- Medicaid fills, this package
- 58 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 016937
- GCN: 26901
- GPI-14 (Medi-Span): 42101020107405
- HICL (First Databank): 002091
- AHFS class code: 12:12.12.00
- RxCUI (RxNorm): 1049154
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
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 ↗- It temporarily relieves nasal congestion from the common cold, hay fever or other upper respiratory allergies. Many products also relieve sinus congestion and pressure.
- It depends on the product. Regular tablets and softgels are usually taken every 4 to 6 hours, while 12-hour extended-release tablets are taken every 12 hours. Check your box for th...
- No. Swallow them whole. Don't divide, crush, chew or dissolve them. Seeing part of the tablet in your stool can happen and is normal.
- Can I crush or chew the extended-release tablets?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.277 | $2.77 / 10 tablet |
| Medicaid paysCMS SDUD · 12 mo | $0.7200 | $7.20 / 10 tablet |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Mar 4, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70000-0475-01 You're viewing this Main listing | 10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2019-02-11 | Mar 31, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pseudoephedrine Hydrochloride 120 mg 62011-0306-01 | STRATEGIC | 10 tablets | $0.274 | — | FDA listed | save 1% |
| leader 12 hour nasal decongestant 120 mgthis 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 | +2% |
| sinus 12 hour 120 mg 00113-2017-60 | L. | 1 tablet | $0.281 | — | Availability likely | +2% |
| SudoGest 12 Hour 120 mg 00904-6754-15 | Major | 1 tablet | $0.281 | — | Availability likely | +2% |
| Pseudoephedrine hydrochloride 120 mg 00904-7409-15 | Major | 10 tablets | $0.281 | — | Availability likely | +2% |
| good neighbor pharmacy nasal decongestant 120 mg 24385-0054-52 | Amerisource | 1 tablet | $0.281 | — | Availability likely | +2% |
| pseudoephedrine hydrochloride 120 mg 45802-0107-52 | Padagis | 1 tablet | $0.281 | — | Availability likely | +2% |
| Pseudoephedrine hydrochloride 120 mg 51660-0204-21 | Ohm | 20 tablets | $0.281 | — | Availability likely | +2% |
| Pseudoephedrine hydrochloride 120 mg 51660-0492-21 | Ohm | 20 tablets | $0.281 | — | Availability likely | +2% |
| Pseudoephedrine Hydrochloride 120 mg 70000-0601-01 | CARDINAL | 20 tablets | $0.281 | — | Availability likely | +2% |
| 12 Hour Nasal Decongestant 120 mg 70000-0656-01 | CARDINAL | 10 tablets | $0.281 | — | Availability likely | +2% |
| nasal decongestant 120 mg 70677-0001-01 | Strategic | 10 tablets | $0.281 | — | Availability likely | +2% |
| Pseudoephedrine hydrochloride 120 mg 70677-1019-01 | STRATEGIC | 10 tablets | $0.281 | — | Availability likely | +2% |
| 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 mg 58602-0804-67 | 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 | — |
| Pseudoephedrine Hydrochloride 120 mg 00363-0204-20 | Walgreen | 20 tablets | — | — | FDA listed | — |
| nasal decongestant 120 mg 42507-0054-52 | HyVee | 1 tablet | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Mar 4, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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.
🧪 Avoiding an ingredient? See Pseudoephedrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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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.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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.
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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.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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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.
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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.
9 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Cardinal Health 110, LLC. dba Leader labeler code 70000
- Leader Extra Strength Sugar Free Antacid 750 mg Tablet, Chewable NDC 70000-0460-1
- Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE 2 mg Capsule, Liquid Filled NDC 70000-0461-1
- Mucus Relief DM Extended Release Caplets Guaifenesin, Dextromethorphan HBr 60 mg; 1200 mg Tablet NDC 70000-0464-1
- Zinc Oxide 40% Diaper Rash Skin Protectent 40 g/100g Ointment NDC 70000-0469-1
- leader childrens allergy relief Loratadine 5 mg/5mL Solution NDC 70000-0473-1
- leader childrens allergy relief Diphenhydramine HCl 12.5 mg/5mL Solution NDC 70000-0474-1
- Leader Regular Strength Chocolate Laxative sennosides 15 mg Tablet NDC 70000-0477-1
- LEADER Ear Drops for Swimmers 950 mg/mL Liquid NDC 70000-0478-1
- Mucus Relief Extended Release Maximum Strength Guaifenesin 1200 mg Tablet NDC 70000-0479-1
- Medicated Chest Rub camphor, eucalyptus oil, menthol 48 mg/g; 12 mg/g; 26 mg/g Ointment NDC 70000-0480-1
- leader childrens pain and fever Acetaminophen 160 mg/5mL Suspension NDC 70000-0481-1
- Hydrocortisone Anti-pruritic 1 g/100g Cream NDC 70000-0485-1
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 45 mg • store at 20-25°C (68-77°F) in a dry place • protect from light • do not use if blister unit is broken or torn • see carton end panel for lot number and expiration date • this product meets the requirements of USP Drug Release Test 3
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Pseudoephedrine HCl 120 mg
🧪 Inactive Ingredients ▾
Inactive ingredients carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
🎯 Purpose ▾
Purpose Nasal decongestant
📄 Ask a Doctor Before Use If ▾
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 ▾
When using this product do not exceed recommended dosage
📄 Stop Use and Ask a Doctor If ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
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).
📄 Questions or Comments ▾
Questions or comments? 1-800-719-9260
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Maximum Strength | Non-Drowsy 12-Hour Nasal Decongestant Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg Nasal Decongestant | Sinus COMPARE TO SUDAFED® SINUS CONGESTION 12 HOUR MAXIMUM STRENGTH active ingredient Sinus Pressure + Congestion 10 COATED CAPLETS* *Capsule-shaped Tablets Actual Size 100% Money Back Guarantee 054E9-12HR-nasal.jpg