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TYLENOL Extra Strength Acetaminophen 500 mg Capsule, Liquid Filled, 18-count — NDC 50580-469-18 (Billing 50580-0469-18)

by Kenvue Brands LLC · 1 BOTTLE in 1 CARTON / 18 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 18 capsules of TYLENOL Extra Strength Acetaminophen 500 mg Capsule, Liquid Filled from Kenvue Brands LLC, marketed since Oct 2025 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 50580-0469-18
🏷️ FDA NDC (as labeled) 50580-469-18 billing pads the product segment with a zero
This package
Contains18-count Pack sizes3 compare ↓
Main listing for product 50580-469 · Also comes in: 40 capsules 50580-469-40 75 capsules 50580-469-75
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

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50580-469-18
Product NDC 50580-469
11-digit billing NDC 50580046918
RxCUI 198439, 351580
UNII 362O9ITL9D
UPC 0300450439185
Application # M013
SPL Set ID 3bb7dc60-97b2-1291-e063-6294a90a26d9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-27
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 198439
Why two NDCs? The FDA registers this code as 50580-469-18 — 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 → 50580-0469-18. 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 Anilides class.

Drug family (ATC) Anilides
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

📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 mLPer 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: 40 capsules 75 capsules
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
50580-0469-18 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 18 CAPSULE, LIQUID FILLED in 1 BOTTLE 2025-10-27 — Active
50580-0469-40 50580-469-40 1 BOTTLE in 1 CARTON / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 2025-10-27 — Active
50580-0469-75 50580-469-75 1 BOTTLE in 1 CARTON / 75 CAPSULE, LIQUID FILLED in 1 BOTTLE 2025-10-27 — Active

Pack size FAQ

What quantity is in this package?
This is a 18-count package — 1 bottle in 1 carton / 18 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 50580-0469-40?
Both are TYLENOL Extra Strength Acetaminophen 500 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 18-count one, while NDC 50580-0469-40 is the 40 capsules package.
What NDC number is used to bill for this package of TYLENOL Extra Strength Acetaminophen 500 mg Capsule, Liquid Filled?
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
MAPAP Extra Strength 500 mg 00904-1987-60 Major 100 capsules $0.035 — Availability likely —
Pain Reliever 500 mg 00363-1178-50 Walgreens 50 capsules — — FDA listed —
Pain Reliever 500 mg 00363-6684-50 Walgreens 50 capsules — — FDA listed —
Acetaminophen 500 mg 35916-0183-02 Softgel 3000 capsules — — FDA listed —
Extra Strength Mini Softgels Pain Reliever 500 mg 41226-0101-50 THE 50 capsules — — FDA listed —
TYLENOL Extra Strength 500 mgthis 50580-0469-18 Kenvue 18 capsules — — FDA listed —
Extra Strength Mini Softgels Pain Reliever 500 mg 51316-0444-18 CVS 18 capsules — — FDA listed —
Pain Relief Extra Strength 500 mg 53345-0019-01 Humanwell 3000 capsules — — FDA listed —
Rapidol 500 mg 55758-0503-24 Pharmadel 24 capsules — — FDA listed —
Vicks PainQuil LIQUICAPS PAIN RELIEVER 500 mg 84126-0376-01 The 100 capsules — — FDA listed —
Extra Strength Pain Relief 500 mg 57896-0251-01 Geri-Care 100 capsules — — FDA listed —
Easyfast 500 mg 83174-0613-26 Easyfast 2 capsules — — Discontinued —
CVS Acetaminophen 500 mg 51316-0185-00 CVS 500 capsules — — FDA listed —
CVS Acetaminophen 500 mg 51316-0188-00 CVS 500 capsules — — FDA listed —
Extra Strength Acetaminophen 500 mg 87438-0001-01 Pinnacle 100 capsules — — 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

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 applicationM013 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedOct 2025
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 📄 Ask a Doctor or Pharmacist Before Use If 📄 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 35 words ▾

Uses temporarily relieves minor aches and pains due to: ​■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps temporarily reduces fever

⏱️ Dosage and Administration 62 words ▾

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 capsules every 6 hours while symptoms last do not take more than 6 capsules in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 27 words ▾

Other information store between 20-25°C (68-77°F) do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing

🧪 Active Ingredient 8 words ▾

Active ingredient (in each capsule) Acetaminophen 500 mg

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, sorbitol, titanium dioxide

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

📄 Do Not Use 42 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product

📄 Ask a Doctor Before Use If 10 words ▾

Ask a doctor before use if you have liver disease

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 9 words ▾

Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL NDC 50580-469-18 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever - Fever Reducer LIQUID GELS Actual Size 18 Liquid Gels* 500 mg each *Liquid Filled Capsules tylenol-1

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 — Not published for this NDC No photo available yet for this listing.
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 40 capsules (50580-0469-40), 75 capsules (50580-0469-75). 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.
← 50580-0460-01 · Kenvue 50580-0472-01 · 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.