Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
sinus and nasal decongestant Pseudoephedrine Hydrochloride 120 mg Tablet, Film Coated, Extended Release — NDC 51316-616-60 (Billing 51316-0616-60)
by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
This is a package of sinus and nasal decongestant Pseudoephedrine Hydrochloride 120 mg Tablet, Film Coated, Extended Release from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, marketed since Jan 2026 and currently FDA-listed.
NDC 51316-0616-60
🏷️ FDA NDC (as labeled)
51316-616-60
billing pads the product segment with a zero
This package
Contains1 tablet, film coated, extended release in 1 blister pack
Pack sizes2 compare ↓
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 51316-616-60 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 51316 labeler · 616 product · 60 package
- Package marketed since
- Jan 28, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5131661660 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
51316-616-60
Product NDC
51316-616
11-digit billing NDC
51316061660
RxCUI
1049154
UNII
6V9V2RYJ8N
Application #
ANDA075153
SPL Set ID
e39daa3c-1901-4966-b85e-ab76d7bd1216
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
2026-01-20
Route
ORAL
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1049154
Why two NDCs?
The FDA registers this code as 51316-616-60 — 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 → 51316-0616-60. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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
- 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?
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Pseudoephedrine Hydrochloride?
Ask a pharmacist →
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 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.
Try another pack size:
1 tablet
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 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 |
|---|---|---|---|---|
| 51316-0616-52 51316-616-52 Main listing | 10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2026-01-20 | — | Active |
| 51316-0616-60 You're viewing this | 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2026-01-28 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack.
What NDC number is used to bill for this package of sinus and nasal decongestant Pseudoephedrine Hydrochloride 120 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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 | — |
| 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 mgthis 51316-0616-60 | 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 | — |
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
White
ShapeOval
ImprintL054
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.
- FDA label on DailyMed · label index refreshed Oct 5, 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.
-
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 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 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.
-
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 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.
-
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.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, 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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
Manufacturer & labeler
LabelerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application holderL PERRIGO CO
FDA applicationANDA075153 (ANDA)
Labeler code51316
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio119 products on file
More NDCs from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED labeler code 51316
- infants pain and fever Acetaminophen 160 mg/5mL Suspension NDC 51316-606-16
- ALLERGY RELIEF D12 Cetirizine hydrochloride, Pseudoephedrine hydrochloride 5 mg; 120 mg Tablet, Film Coated, Extended Release NDC 51316-607-53
- Naproxen Sodium 220 mg Tablet NDC 51316-608-90
- CHILDRENS ALLERGY RELIEF Loratadine 5 mg/5mL Solution NDC 51316-611-34
- daytime severe acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 325 mg/15mL; 10 mg/15mL; 200 mg/15mL; 5 mg/15mL Solution NDC 51316-613-40
- CVS Hydration Eye Drops Polyetylene glycol 400, Propylene .3 g/100mL; 400 .4 g/100mL Solution/ Drops NDC 51316-615-10
- Daytime Cold and Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL 325 mg/15mL; 10 mg/15mL; 5 mg/15mL Liquid NDC 51316-617-12
- CVS DT and NT Combo Pack Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate Kit NDC 51316-618-12
- Ultrastrength Gas Relief Simethicone Soft Gelatin Capsules 180 mg Capsule NDC 51316-621-76
- CVS Itch Relief Pramoxine Hydrochloride, Zinc Acetate 10 mg/g; 1 mg/g Spray NDC 51316-624-03
- Mucus Relief Sinus Pressure Pain and Cough Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated NDC 51316-627-09
- CVS Severe Multi-Symptom Cough Cold Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid NDC 51316-630-04
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 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
📄 Do Not Use ▾
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 ▾
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 CVS TM 12 HR actual size Non-Drowsy SINUS & NASAL DECONGESTANT Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg Nasal Decongestant Compare To Sudafed® Sinus Congestion 12 Hour active ingredient 10 COATED CAPLETS† †Capsule-Shaped Tablets Maximum Strength 12-Hour Relief of: Sinus pressure & congestion sinus-&-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 ↗
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 sinus and nasal decongestant (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 7%
Female · 93%
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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. 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 1 tablet (51316-0616-52). 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?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 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.
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.