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ZYRTEC-D Allergy Plus Congestion Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release — NDC 50580-0728-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZYRTEC-D Allergy Plus Congestion Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release — NDC 50580-728-24 (Billing 50580-0728-24)

by Kenvue Brands LLC · 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of ZYRTEC-D Allergy Plus Congestion Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release from Kenvue Brands LLC, marketed since Jan 2008 and currently FDA-listed.

NDC 50580-0728-24
🏷️ FDA NDC (as labeled) 50580-728-24 billing pads the product segment with a zero
This package
Contains6 tablet, film coated, extended release in 1 blister pack Pack sizes3 compare ↓
Product page 50580-0728-12 Also comes in: 6 tablets 50580-728-12 6 tablets 50580-728-25
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 50580-728-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50580 labeler · 728 product · 24 package
Package marketed since
Jan 1, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5058072824 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50580-728-24
Product NDC 50580-728
11-digit billing NDC 50580072824
NCPDP billing unit EA — each (per item)
RxCUI 1014571, 1014583
UNII 64O047KTOA, 6V9V2RYJ8N
Application # NDA021150
SPL Set ID 1e8eb279-3522-40e4-8062-06b5354f0d29
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-01-01
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43993002277420
GPI class ZyrTEC-D Allergy & Congestion
GCN Seq No 048415
GCN 13866
HICL code 022864
Ingredient (HICL) Cetirizine Hcl/Pseudoephedrine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2O
Therapeutic class — specific (HIC3) 2Nd Gen Antihistamine And Decongestant Combination
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name ZYRTEC-D ER 5 MG-120 MG TABLET
FDB brand name Zyrtec-D
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 048415
  • GCN: 13866
  • GPI-14 (Medi-Span): 43993002277420
  • HICL (First Databank): 022864
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1014571
Why two NDCs? The FDA registers this code as 50580-728-24 — 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 → 50580-0728-24. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives, Other antiallergics
How it works Histamine H1 Receptor Antagonists
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.

Clinical

Label name ZYRTEC-D ER 5 MG-120 MG TABLET Ingredient Cetirizine Hcl/Pseudoephedrine
📗 Our plain-language guide HelloPharmacist
  • Great question. It's a two-in-one product. Cetirizine is an antihistamine that targets allergy symptoms like runny nose, sneezing, and itchy, watery eyes. Pseudoephedrine is a deco...
  • What exactly does this medication do — why does it have two ingredients?
  • No — please don't. These are extended-release tablets, which means they're specially designed to release medication slowly over 12 hours. Breaking or chewing the tablet can dump to...
  • Can I break the tablet in half if it's hard to swallow?
📖 Read our full Cetirizine / 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.

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: 6 tablets 6 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50580-0728-12 50580-728-12 Main listing 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2008-01-01 — Active
50580-0728-24 You're viewing this 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2008-01-01 — Active
50580-0728-25 50580-728-25 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2008-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack.
What NDC number is used to bill for this package of ZYRTEC-D Allergy Plus Congestion Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
All Day Allergy D 5 mg/1; 120 mg 00113-2147-62 L. 1 tablet $0.563 — Availability likely —
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 00536-1279-12 Rugby 1 tablet $0.563 — Availability likely —
Cetirizine hydrochloride and Pseudoephedrine hydrochloride 5 mg/1; 120 mg 45802-0147-53 Padagis 1 tablet $0.563 — Availability likely —
good neighbor pharmacy all day allergy d 5 mg/1; 120 mg 46122-0626-62 Amerisource 1 tablet $0.563 — Availability likely —
Leader Allergy Relief D 5 mg/1; 120 mg 70000-0042-01 Cardinal 1 tablet $0.563 — Availability likely —
Allergy relief-D 5 mg/1; 120 mg 70677-1020-01 STRATEGIC 6 tablets $0.563 — Availability likely —
Foster And Thrive All Day Allergy D 5 mg/1; 120 mg 70677-1311-01 Strategic 1 tablet $0.563 — Availability likely —
good sense all day allergy d 5 mg/1; 120 mg 00113-0147-53 L. 1 tablet — — Discontinued —
Wal-Zyr D 5 mg/1; 120 mg 00363-0989-12 Walgreen 6 tablets — — FDA listed —
allergy relief D12 5 mg/1; 120 mg 00363-4923-53 Walgreen 1 tablet — — FDA listed —
allergy relief-D 5 mg/1; 120 mg 11822-3009-00 Rite 1 tablet — — FDA listed —
Allergy relief-D 5 mg/1; 120 mg 11822-9994-01 RITE 6 tablets — — FDA listed —
signature care allergy relief d 5 mg/1; 120 mg 21130-0644-62 Safeway 1 tablet — — FDA listed —
all day allergy d 5 mg/1; 120 mg 30142-0450-62 Kroger 1 tablet — — FDA listed —
Allergy and Sinus Relief 5 mg/1; 120 mg 30142-0633-62 Kroger 1 tablet — — FDA listed —
topcare all day allergy d 5 mg/1; 120 mg 36800-0744-62 Topco 1 tablet — — FDA listed —
allergy relief d 5 mg/1; 120 mg 37808-0651-53 H 1 tablet — — FDA listed —
12 hour allergy d 5 mg/1; 120 mg 41250-0728-53 Meijer 1 tablet — — FDA listed —
Zyrtec-D 5 mg/1; 120 mg 50580-0719-12 Kenvue 6 tablets — — FDA listed —
ZYRTEC-D Allergy Plus Congestion 5 mg/1; 120 mgthis 50580-0728-24 Kenvue 6 tablets — — FDA listed —
Allergy Relief D12 5 mg/1; 120 mg 51316-0607-53 CVS 1 tablet — — FDA listed —
Allergy relief-D 5 mg/1; 120 mg 51660-0940-12 Ohm 6 tablets — — FDA listed —
allergy relief d 5 mg/1; 120 mg 56062-0147-53 Publix 1 tablet — — FDA listed —
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 58602-0703-09 Aurohealth 2 tablets — — FDA listed —
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 62756-0915-62 Sun 6 tablets — — FDA listed —
kirkland signature aller tec d 5 mg/1; 120 mg 63981-0147-62 Costco 1 tablet — — FDA listed —
Allergy relief-D 5 mg/1; 120 mg 68016-0531-24 CHAIN 24 tablets — — FDA listed —
allergy relief d 5 mg/1; 120 mg 69842-0415-53 CVS 1 tablet — — FDA listed —
Allergy Relief-D 5 mg/1; 120 mg 69842-0994-12 CVS 6 tablets — — FDA listed —
equate allergy relief d nasal decongestant 5 mg/1; 120 mg 79903-0126-14 WALMART 1 tablet — — FDA listed —
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 29300-0313-22 Unichem 6 tablets — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

What it looks like

Color white
ShapeRound
ImprintZyrtec;D
Size1 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.

🧪 Avoiding an ingredient? See Cetirizine / 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 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 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 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 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 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 statescolloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.

Manufacturer & labeler

LabelerKenvue Brands LLC
Application holderKENVUE BRANDS LLC
FDA applicationNDA021150 (NDA)
Labeler code50580
First marketedJan 2008
Product typeHuman Otc Drug
Portfolio567 products on file

More NDCs from Kenvue Brands LLC labeler code 50580

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 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 📄 Ask a Doctor or Pharmacist 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 46 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 59 words ▾

Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. 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 thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease.

Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs.

Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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 23 words ▾

Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if blister unit is broken

🧪 Active Ingredient 19 words ▾

Active ingredients (in each extended release tablet) Purpose Cetirizine HCl 5 mg Antihistamine Pseudoephedrine HCl 120 mg Nasal decongestant

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

🎯 Purpose 19 words ▾

Active ingredients (in each extended release tablet) Purpose Cetirizine HCl 5 mg Antihistamine Pseudoephedrine HCl 120 mg Nasal decongestant

📄 Do Not Use 77 words ▾

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. 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 39 words ▾

Ask a doctor before use if you have heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose.

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

📄 When Using This Product 33 words ▾

When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 37 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever

🤰 If Pregnant or Breast-Feeding 16 words ▾

If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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 7 words ▾

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 58 words ▾

PRINCIPAL DISPLAY PANEL Original Prescription Strength NDC 50580-728-24 ZYRTEC-D ® Cetirizine HCl 5 mg /antihistamine Pseudoephedrine HCl 120 mg /nasal decongestant Extended Release Tablets ALLERGY + CONGESTION INDOOR + OUTDOOR ALLERGIES 12 HOUR RELIEF OF Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose Sinus Pressure Nasal Congestion (Actual Size) 24 EXTENDED RELEASE TABLETS Principal Display Panel

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 ZYRTEC-D Allergy Plus Congestion (this brand).

Top reported reactions

Fatigue408
Pain402
Rash355
Abdominal Discomfort333
Alopecia329
Rheumatoid Arthritis324
Pemphigus322

Age at onset

Neonate9
Infant4
Child49
Adolescent39
Adult638
Elderly236

Reporter sex

2,969 reports
Male · 23%
Female · 77%

Serious outcomes

Hospitalization500
Disabling393
Life-threatening339
Death306
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 272 0
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 Kenvue Brands 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 2 other package presentations of this same product, including 6 tablets (50580-0728-12), 6 tablets (50580-0728-25). 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?
Kenvue Brands 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.
← 50580-0726-03 · Kenvue 50580-0730-01 · Kenvue →
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.