Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
SUDAFED Sinus Congestion Pseudoephedrine Hydrochloride 30 mg Tablet, Film Coated — NDC 50580-363-03 (Billing 50580-0363-03)
by Kenvue Brands LLC · 3 CARTON in 1 PACKAGE / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK
This is a package of SUDAFED Sinus Congestion Pseudoephedrine Hydrochloride 30 mg Tablet, Film Coated from Kenvue Brands LLC, marketed since Jul 2021 and currently FDA-listed.
NDC 50580-0363-03
🏷️ FDA NDC (as labeled)
50580-363-03
billing pads the product segment with a zero
This package
Contains12 tablet, film coated in 1 blister pack
Pack sizes3 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 50580-363-03 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 50580 labeler · 363 product · 03 package
- Package marketed since
- Feb 7, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0300810865241
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
50580-363-03
Product NDC
50580-363
11-digit billing NDC
50580036303
NCPDP billing unit
EA — each (per item)
UNII
6V9V2RYJ8N
UPC
0300810865241
Application #
M012
SPL Set ID
c05d7e27-6821-468f-b27d-9c0b02a07b0f
Established class (EPC)
alpha-Adrenergic Agonist
Mechanism of action
Adrenergic alpha-Agonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-07-31
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
42101020100305
GCN Seq No
005089
GCN
20481
HICL code
002091
Ingredient (HICL)
Pseudoephedrine 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
12:12.12.00
AHFS class
Alpha- And Beta-Adrenergic Agonists
FDB label name
SUDAFED 30 MG TABLET
FDB brand name
Sudafed
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 005089
- GCN: 20481
- GPI-14 (Medi-Span): 42101020100305
- HICL (First Databank): 002091
- AHFS class code: 12:12.12.00
- RxCUI (RxNorm): 1049160
Why two NDCs?
The FDA registers this code as 50580-363-03 — 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 → 50580-0363-03. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 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
Label name SUDAFED 30 MG TABLET Ingredient Pseudoephedrine Hcl
📖 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 3, 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.
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 4, 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 |
|---|---|---|---|---|
| 50580-0363-01 50580-363-01 Main listing | 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2021-07-31 | — | Active |
| 50580-0363-02 50580-363-02 | 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2021-07-31 | — | Active |
| 50580-0363-03 You're viewing this | 3 CARTON in 1 PACKAGE / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2022-02-07 | — | 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 / 12 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of SUDAFED Sinus Congestion Pseudoephedrine Hydrochloride 30 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Sense Nasal Decongestant 30 mg 00113-0432-62 | L. | 24 tablets | $0.078 | — | Availability likely | — |
| Nasal Decongestant 30 mg 00536-3607-35 | Rugby | 24 tablets | $0.078 | — | Availability likely | — |
| SudoGest 30 mg 00904-5053-59 | Major | 100 tablets | $0.078 | — | Availability likely | — |
| SudoGest Nasal Decongestant 30 mg 00904-6337-24 | Major | 1 tablet | $0.078 | — | Availability likely | — |
| SudoGest 30 mg 00904-6727-60 | Major | 100 tablets | $0.078 | — | Availability likely | — |
| Pseudoephedrine HCl 30 mg 00904-6990-61 | Major | 10 tablets | $0.078 | — | Availability likely | — |
| pseudoephedrine hydrochloride 30 mg 45802-0432-62 | Padagis | 1 tablet | $0.078 | — | Availability likely | — |
| Nasal Decongestant Maximum Strength, Non-Drowsy 30 mg 46122-0428-62 | Amerisource | 24 tablets | $0.078 | — | Availability likely | — |
| Leader Nasal Decongestant 30 mg 70000-0002-01 | Cardinal | 1 tablet | $0.078 | — | Availability likely | — |
| Nasal Decongestant Maximum Strength 30 mg 70677-1017-01 | Strategic | 24 tablets | $0.078 | — | Availability likely | — |
| Nasal Decongestant D 30 mg 00363-1214-08 | Walgreen | 24 tablets | — | — | FDA listed | — |
| Sinus Pressure and Congestion Relief Maximum Strength 30 mg 11822-0112-02 | Rite | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Maximum Strength 30 mg 21130-0112-08 | Better | 24 tablets | — | — | FDA listed | — |
| sinus 30 mg 30142-0613-62 | Kroger | 1 tablet | — | — | Discontinued | — |
| Sinus Decongestion 30 mg 30142-0641-08 | Kroger | 24 tablets | — | — | FDA listed | — |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy 30 mg 36800-0432-62 | Topco | 1 tablet | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 37808-0112-22 | H | 24 tablets | — | — | FDA listed | — |
| equaline nasal decongestant non drowsy maximum strength 30 mg 41163-0432-67 | United | 6 tablets | — | — | FDA listed | — |
| nasal decongestant maximum strength non drowsy 30 mg 41250-0432-62 | Meijer | 1 tablet | — | — | FDA listed | — |
| CareOne Nasal and Sinus Decongestant 30 mg 41520-0881-62 | American | 12 tablets | — | — | FDA listed | — |
| Sinus and Congestion Non-Drowsy 30 mg 49035-0780-08 | Wal-Mart | 24 tablets | — | — | FDA listed | — |
| Sudogest 30 mg 50090-1961-00 | A-S | 28 tablets | — | — | FDA listed | — |
| Sudogest Nasal Decongestant 30 mg 50090-4345-00 | A-S | 48 tablets | — | — | Discontinued | — |
| pseudoephedrine hydrochloride 30 mg 50090-5615-01 | A-S | 1 tablet | — | — | FDA listed | — |
| SUDAFED Sinus Congestion 30 mgthis 50580-0363-03 | Kenvue | 12 tablets | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 50844-0112-08 | L.N.K. | 12 tablets | — | — | FDA listed | — |
| Sinus and Nasal Decongestant 30 mg 51316-0121-22 | CVS | 24 tablets | — | — | FDA listed | — |
| Sinus And Nasal Decongestant 30 mg 51316-0317-62 | CVS | 12 tablets | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 56062-0432-62 | Publix | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Non-Drowsy 30 mg 59779-0112-08 | CVS | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 59779-0432-62 | CVS | 1 tablet | — | — | FDA listed | — |
| Nasal Decongestant 30 mg 63187-0344-24 | Proficient | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Maximum Strength 30 mg 63868-0802-24 | CHAIN | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant Maximum Strength 30 mg 68016-0473-24 | Chain | 24 tablets | — | — | FDA listed | — |
| pseudoephedrine hydrochloride 30 mg 71205-0197-24 | Proficient | 1 tablet | — | — | FDA listed | — |
| Sinus Congestion 30 mg 83324-0054-24 | Chain | 24 tablets | — | — | FDA listed | — |
| pseudoephedrine hydrochloride 30 mg 85766-0049-24 | Sportpharm | 1 tablet | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
red
ShapeRound
ImprintSU
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.
- FDA label on DailyMed · label index refreshed Oct 3, 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 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
LabelerKenvue Brands LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedJul 2021
Product typeHuman Otc Drug
Portfolio567 products on file
More NDCs from Kenvue Brands LLC labeler code 50580
- Benadryl Allergy Extra Strength Liqui-Gels Diphenhydramine Hydrochloride 50 mg Capsule, Liquid Filled NDC 50580-322-20
- Infants TYLENOL Acetaminophen 160 mg/5mL Suspension NDC 50580-325-01
- IMODIUM Multi-Symptom Relief loperamide hydrochloride and dimethicone 2 mg; 125 mg Tablet NDC 50580-338-06
- Childrens Benadryl Allergy Plus Congestion Diphenhydramine hydrochloride and Phenylephrine 12.5 mg/5mL; 5 mg/5mL Solution NDC 50580-341-01
- Extra Strength TYLENOL Cold Plus Flu Multi-Action Day acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide 15 mg; 500 mg; 30 mg Tablet, Film Coated NDC 50580-344-01
- Loperamide Hydrochloride and Dimethicone 2 mg; 125 mg Tablet NDC 50580-345-00
- SUDAFED OM Sinus Severe No Drip Nasal Mist Oxymetazoline Hydrochloride 50 mg/100mL Spray NDC 50580-364-01
- Imodium A-D Loperamide Hydrochloride 2 mg Capsule, Liquid Filled NDC 50580-367-01
- SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol Oxymetazoline Hydrochloride 50 mg/100mL Spray NDC 50580-368-01
- Tylenol Cold plus Flu plus Cough Night Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL Solution NDC 50580-369-01
- Benadryl diphenhydramine hydrochloride Kit NDC 50580-370-01
- Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate Kit NDC 50580-374-01
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 sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
⏱️ Dosage and Administration ▾
Directions adults and children 12 years and over take 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 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 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 ▾
Other information store between 20 - 25°C (68 - 77°F) do not use if blister unit is torn or broken see side panel for lot number and expiration date
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg
🧪 Inactive Ingredients ▾
Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, 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 dose
📄 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? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL PREVIOUSLY SUDAFED ® CONGESTION NDC 50580-363-02 SUDAFED ® SINUS CONGESTION Pseudoephedrine HCl 30 mg, Nasal Decongestant actual size MAXIMUM STRENGTH SINUS PRESSURE SINUS CONGESTION 24 TABLETS NON-DROWSY Principal Display Panel
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 SUDAFED Sinus Congestion (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 7%
Female · 93%
Unknown · 0%
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 12 tablets (50580-0363-01), 12 tablets (50580-0363-02). 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.
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.