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Sudafed PE Sinus Congestion Phenylephrine Hydrochloride 10 mg Tablet, Film Coated — NDC 50580-0437-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sudafed PE Sinus Congestion Phenylephrine Hydrochloride 10 mg Tablet, Film Coated — NDC 50580-437-03 (Billing 50580-0437-03)

by Kenvue Brands LLC · 3 CARTON in 1 PACKAGE / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Sudafed PE Sinus Congestion Phenylephrine Hydrochloride 10 mg Tablet, Film Coated from Kenvue Brands LLC, marketed since Jun 2019 and currently FDA-listed.

NDC 50580-0437-03
🏷️ FDA NDC (as labeled) 50580-437-03 billing pads the product segment with a zero
This package
Contains18 tablet, film coated in 1 blister pack Pack sizes3 compare ↓
Product page 50580-0437-01 Also comes in: 18 tablets 50580-437-01 18 tablets 50580-437-02
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50580-437-03
Product NDC 50580-437
11-digit billing NDC 50580043703
RxCUI 1049182, 1052767
UNII 04JA59TNSJ
UPC 0300450581365
Application # M012
SPL Set ID 2ca08917-1a75-4365-8520-c083e6a4225a
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 42101040100310
GCN Seq No 058496
GCN 23944
HICL code 002087
Ingredient (HICL) Phenylephrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B6V
Therapeutic class — specific (HIC3) Decongestants, Oral
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name SUDAFED PE 10 MG TABLET
FDB brand name Sudafed Pe
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 058496
  • GCN: 23944
  • GPI-14 (Medi-Span): 42101040100310
  • HICL (First Databank): 002087
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1049182
Why two NDCs? The FDA registers this code as 50580-437-03 — 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 → 50580-0437-03. 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-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-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.

Clinical

Label name SUDAFED PE 10 MG TABLET Ingredient Phenylephrine Hcl
📖 What it is MedlinePlus · NLM

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The injection raises low blood pressure during anesthesia and, for some products, septic shock. Eye drops dilate the pupil, nasal products relieve conges...
  • Be careful. Over-the-counter phenylephrine should not be used with a prescription MAOI or within 2 weeks of stopping one. If you aren't sure whether your medicine is an MAOI, ask m...
  • With the injection, the most common are nausea, vomiting and headache. Call for help right away if you have chest pain, a very slow heartbeat, or pain or skin changes around the IV...
  • Stop and talk to a doctor if you get nervousness, dizziness or sleeplessness. Also stop if symptoms last more than 7 days or come with a fever. Don't use more than the label recomm...
📖 Read our full Phenylephrine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:

Butcher's BroomModerate
🌿 Every supplement checked against Phenylephrine Hydrochloride (1 interactions) — ranked by severity →
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: 18 tablets 18 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
50580-0437-01 50580-437-01 Main listing 1 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK 2019-06-17 — Active
50580-0437-02 50580-437-02 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK 2019-06-17 — Active
50580-0437-03 You're viewing this 3 CARTON in 1 PACKAGE / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK 2019-09-03 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 carton in 1 package / 2 blister pack in 1 carton / 18 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Sudafed PE Sinus Congestion Phenylephrine Hydrochloride 10 mg Tablet, Film Coated?
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
Nasal Decongestant PE Maximum Strength 10 mg 70677-1152-01 Strategic 18 tablets $0.050 — Availability likely —
Nasal Decongestant PE 10 mg 00363-4531-07 Walgreen 18 tablets — — FDA listed —
PhysiciansCare Sinus Non-Drowsy 10 mg 00924-0133-01 Acme 1 tablet — — FDA listed —
Sinus Pressure and Congestion Relief PE Maximum Strength 10 mg 11822-4530-02 Rite 24 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 21130-0453-07 Better 18 tablets — — FDA listed —
Sinus Decongestion PE 10 mg 30142-0534-07 Kroger 18 tablets — — FDA listed —
Sinus Congestion 10 mg 30142-0853-07 Kroger 18 tablets — — FDA listed —
PE Sinus Congestion 10 mg 36800-0704-07 Topco 18 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 37808-0453-23 H 24 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 37835-0651-01 Bi-Mart 100 tablets — — FDA listed —
Medi-First Sinus Decongestant 10 mg 47682-0809-13 Unifirst 1 tablet — — FDA listed —
Medi-First Plus Sinus Decongestant 10 mg 47682-0990-33 Unifirst 1 tablet — — FDA listed —
Unishield Sinus Decongestant 10 mg 49314-2083-03 Unishield 1 tablet — — FDA listed —
Pseudo Time Pe 10 mg 49483-0234-00 TIME 100000 tablets — — FDA listed —
Good Sense Nasal Decongestant PE 10 mg 50090-3659-00 A-S 36 tablets — — FDA listed —
Phenylephrine HCl Maximum Strength 10 mg 50090-5606-00 A-S 18 tablets — — FDA listed —
Nasal Decongestant Pe 10 mg 50090-7449-00 A-S 18 tablets — — FDA listed —
Sudafed PE Sinus Congestion 10 mgthis 50580-0437-03 Kenvue 18 tablets — — FDA listed —
Sinus Congestion 10 mg 50844-0493-08 L.N.K. 24 tablets — — FDA listed —
Suphedrine PE Sinus Congestion Non-Drowsy 10 mg 55301-0753-23 ARMY 24 tablets — — FDA listed —
SU PHEDRINE PE Non-Drowsy, Maximum Strength 10 mg 57243-0453-44 Salado 18 tablets — — FDA listed —
Su Phedrine Pe Sinus Congestion 10 mg 57243-0953-44 Salado 18 tablets — — FDA listed —
Phenylephrine Hydrochloride 10 mg 57631-0018-00 InvaTech 30000 tablets — — FDA listed —
Nasal Decongestant PE Non-Drowsy Maximum Strength 10 mg 63868-0144-19 CHAIN 18 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength 10 mg 67091-0207-18 WinCo 18 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength Non-Drowsy 10 mg 69168-0272-17 Allegiant 300 tablets — — FDA listed —
Redicare Nasal and Sinus Decongestant 10 mg 71105-0272-02 Redicare 100 tablets — — FDA listed —
Gencare-Nasal Decongestant PE 10 mg 72090-0025-01 Pioneer 300 tablets — — FDA listed —
Gencare-Nasal Decongestant PE 10 mg 72090-0039-01 Pioneer 300 tablets — — FDA listed —
Crane Safety Sinus Decongestant 10 mg 73408-0990-33 Crane 1 tablet — — FDA listed —
ValuMeds Nasal Decongestant Phenylephrine HCl 10 mg 82725-1111-01 Cabinet 300 tablets — — FDA listed —
Goodmeds Non-Drowsy Nasal Decongestant PE 10 mg 82725-4111-01 Cabinet 365 tablets — — FDA listed —
Sinus Congestion 10 mg 83324-0073-18 Chain 18 tablets — — FDA listed —
Phenylephrine Hydrochloride 10 mg 83586-0010-00 HHH 130000 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 83586-0160-01 HHH 100 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 84324-0010-01 NUVICARE 100 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength 10 mg 85766-0178-18 Sportpharm 18 tablets — — FDA listed —
Medi-First Plus Sinus Decongestant 10 mg 85766-0182-01 Sportpharm 1 tablet — — FDA listed —
GoodMeds Nasal Decongestant 10 mg 82725-4011-01 Cabinet 365 tablets — — FDA listed —
ValuMeds Nasal Decongestant PE Phenylephrine 10 mg 82725-1011-01 Cabinet 300 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 80513-0789-01 Advanced 100 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color red
ShapeRound
ImprintWL;80;PE
Size7 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • 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.

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

The official label also statescarnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, 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
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedJun 2019
Product typeHuman Otc Drug
Portfolio567 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.

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 23 words ▾

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

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years ask a doctor

⚠️ Warnings 145 words ▾

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 dose 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 16 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Nasal decongestant

📄 Do Not Use 55 words ▾

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 24 words ▾

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 9 words ▾

When using this product do not exceed recommended dose

📄 Stop Use and Ask a Doctor If 24 words ▾

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 10 words ▾

If pregnant or breast-feeding, 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 9 words ▾

Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 35 words ▾

PRINCIPAL DISPLAY PANEL PREVIOUSLY SUDAFED PE ® CONGESTION NDC 50580-437-02 SUDAFED PE® SINUS CONGESTION Phenylephrine HCl, Nasal Decongestant actual size MAXIMUM STRENGTH SINUS PRESSURE SINUS CONGESTION 36 TABLETS NON-DROWSY 10 mg each Principal Display Panel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 18 tablets (50580-0437-01), 18 tablets (50580-0437-02). 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.
← 50580-0436-01 · Kenvue 50580-0446-01 · 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.