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TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day acetaminophen, Dextromethorphan Hydrobromide 10 mg; 325 mg Capsule, Liquid Filled, 12-count — NDC 50580-0130-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day acetaminophen, Dextromethorphan Hydrobromide 10 mg; 325 mg Capsule, Liquid Filled, 12-count — NDC 50580-130-08 (Billing 50580-0130-08)

by Kenvue Brands LLC · 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of 12 capsules of TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day acetaminophen, Dextromethorphan Hydrobromide 10 mg; 325 mg Capsule, Liquid Filled from Kenvue Brands LLC, marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 50580-0130-08
🏷️ FDA NDC (as labeled) 50580-130-08 billing pads the product segment with a zero
This package
Contains12-count Pack sizes2 compare ↓
Main listing for product 50580-130 · Also comes in: 12 capsules 50580-130-24
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 50580-130-08
Product NDC 50580-130
11-digit billing NDC 50580013008
RxCUI 1867684
UNII 9D2RTI9KYH, 362O9ITL9D
UPC 0300450691248
Application # M012
SPL Set ID 1c444202-19e9-8d04-e063-6394a90a9294
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-25
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN

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

GCN Seq No 088466
GCN 58594
HICL code 006331
Ingredient (HICL) Acetaminophen/Dextromethorphan
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4A
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Analgesic Combinations
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name TYLENOL COLD-FLU M-S DY LIQGEL
FDB brand name Tylenol Cold-Flu M-S Day
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 088466
  • GCN: 58594
  • HICL (First Databank): 006331
  • AHFS class code: 28:08.16.00
  • RxCUI (RxNorm): 1867684
Why two NDCs? The FDA registers this code as 50580-130-08 — 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 → 50580-0130-08. 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

Label name TYLENOL COLD-FLU M-S DY LIQGEL Ingredient Acetaminophen/Dextromethorphan
🧪 What is this product?

Tylenol Cold plus Flu Multi-Symptom Liquid Gels Day is an over-the-counter oral capsule containing acetaminophen and dextromethorphan hydrobromide. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Dextromethorphan is a cough suppressant commonly found in cold and cough products. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this category rather than undergoing individual application review.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 Full Acetaminophen, Dextromethorphan 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: 12 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
50580-0130-08 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2025-03-30 — Active
50580-0130-24 50580-130-24 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2024-09-25 — Active

Pack size FAQ

What quantity is in this package?
This is a 12-count package — 1 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day acetaminophen, Dextromethorphan Hydrobromide 10 mg; 325 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
Acetominophen, Dextromethorphan hydrobromide 10 mg/1; 325 mg 35916-2211-01 Softgel 1500 capsules — — FDA listed —
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day 10 mg/1; 325 mgthis 50580-0130-08 Kenvue 12 capsules — — FDA listed —
Daytime COLD AND FLU 325 mg/1; 10 mg 51013-0666-01 PuraCap 8 capsules — — FDA listed —
Ultra Concentrated Daytime COLD AND FLU 325 mg/1; 10 mg 51013-0667-01 PuraCap 8 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg 51316-0897-16 CVS 8 capsules — — FDA listed —
Daytime Cold and Flu 10 mg/1; 325 mg 53345-0056-01 Humanwell 4000 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg 69168-0474-29 Allegiant 8 capsules — — FDA listed —
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU 325 mg/1; 10 mg 69423-0803-24 The 24 capsules — — FDA listed —
Viro-Flu AM Relief 10 mg/1; 325 mg 69729-0056-10 OPMX 10 capsules — — FDA listed —
Coldtac Severe Cold Max Relief 325 mg/1; 10 mg 69729-0808-10 OPMX 10 capsules — — FDA listed —
tabcin ACTIVE 10 mg/1; 325 mg 69729-0809-10 OPMX 10 capsules — — FDA listed —
Mucinex Fast-Max Cold and Flu Maximum Strength 325 mg/1; 10 mg 72854-0171-08 Reckitt 8 capsules — — FDA listed —
Mucinex Rapid Clear Daytime Pain, Headache, and Cough 325 mg/1; 10 mg 72854-0214-16 Reckitt 16 capsules — — FDA listed —
DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels 325 mg/1; 10 mg 76281-0609-03 AptaPharma 12 capsules — — FDA listed —
AXIV DayTime 325 mg/1; 10 mg 82706-0015-01 VIVUNT 8 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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 orange
ShapeOval
ImprintTY;DT
Size21 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.

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 applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedSep 2024
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 📄 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 18 words ▾

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever

⏱️ Dosage and Administration 55 words ▾

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over ■ take 2 capsules every 4 hours while symptoms last ■ do not take more than 8 capsules in 24 hours children 4 to under 12 years ask a doctor children under 4 years do not use

⚠️ Warnings ~2 min read ▾

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.

Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts 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 32 words ▾

Other information ■ store between 20-25°C (68-77°F) ■ avoid high humidity and excessive heat above 40°C (104°F) ■ protect from light ■ do not use if blister unit is torn or broken

🧪 Active Ingredient 18 words ▾

Active ingredients (in each capsule) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

🎯 Purpose 18 words ▾

Active ingredients (in each capsule) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant

📄 Do Not Use 95 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 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. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 30 words ▾

Ask a doctor before use if you have liver disease persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)

📄 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

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dose

📄 Stop Use and Ask a Doctor If 59 words ▾

Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts 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 41 words ▾

PRINCIPAL DISPLAY PANEL NDC 50580-130-24 TYLENOL ® FOR ADULTS COLD + FLU MULTI-SYMPTOM Liquid Gels Acetaminophen, Dextromethorphan HBr Pain Reliever–Fever Reducer, Cough Suppressant DAY HEAD + BODY ACHES FEVER SORE THROAT COUGH *LIQUID FILLED CAPSULES Actual Size 24 LIQUID GELS* Tylenol-1

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 TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day (this brand).

Top reported reactions

Product Complaint2
Asthenopia1
Choking1
Epistaxis1
Feeling Abnormal1
Foreign Body In Throat1
Poor Quality Product Administered1

Reporter sex

5 reports
Female · 100%
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 1 other package presentation of this same product, including 12 capsules (50580-0130-24). 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.
← 50580-0128-04 · Kenvue 50580-0131-24 · 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.