NDC 69168-0474-51 — Daytime Cold and Flu 325 mg; 10 mg

🆔 Identity & classification

FDA NDC (as labeled) 69168-474-51

Product NDC 69168-474

11-digit billing NDC 69168047451

RxCUI 1867684

UNII 362O9ITL9D, 9D2RTI9KYH

Application # M012

SPL Set ID 69ed2da0-16b2-49eb-91b4-cc5cf328c817

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 2026-01-09

Route ORAL

Dosage form CAPSULE, LIQUID FILLED

Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE

Why two NDCs? The FDA registers this code as 69168-474-51 — 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 → 69168-0474-51. 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.

🏭 Manufacturer & labeler

LabelerAllegiant Health

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code69168

First marketedJan 2026

Product typeHuman Otc Drug

Portfolio113 products on file

🔎 All NDCs from Allegiant Health

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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter liquid-filled capsule taken by mouth, marketed as a daytime cold and flu product under FDA's OTC monograph rules. It contains acetaminophen, a pain reliever and fever reducer commonly used for headache and body aches, and dextromethorphan hydrobromide, a cough suppressant typically used to reduce cough. The combination is intended for oral use to address multiple cold and flu symptoms at once.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

💲 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 mL	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.

Try another pack size: 8 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 mg 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 mgthis 69168-0474-51	Allegiant	10 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

🏛️

2026

On the market since

Jan 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

·

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.

🔬 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 Daytime Cold and Flu — the ingredient across all brands.

Top reported reactions

Anxiety4

Covid-194

Surgery4

Fatigue3

Insomnia3

Nausea3

Product Administration Interrupted3

Reporter sex

Male · 25%

Female · 75%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
69168-0474-29	1 BLISTER PACK in 1 CARTON (69168-474-29) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2026-01-09	Active
69168-0474-51 You're viewing this	2 BLISTER PACK in 1 CARTON (69168-474-51) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2026-01-09	Active

Pack size FAQ

What quantity is in NDC 69168-0474-51?

NDC 69168-0474-51 is listed by the FDA — 2 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack.

What NDC number is used to bill for this package of Daytime Cold and Flu 325 mg; 10 mg Capsule, Liquid Filled?

Bill NDC 69168-0474-51 — the 11-digit billing format is 69168047451. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 69168-474-51, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69168-0474-51, written without dashes as 69168047451. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 69168-0474-51, the first segment (69168) is the labeler code FDA assigned to Allegiant Health; the middle segment (0474) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (51) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Allegiant Health. 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 8 capsules (69168-0474-29). 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?

Allegiant Health 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 20 words ▾

Use(s) temporarily relieves these symptoms due to cold flu: cough sore throat headache minor aches and pains temporarily reduces fever

⏱️ Dosage and Administration 45 words ▾

Directions do not take more than the recommended dose Adults and children 12 years and over: Take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor Children under 12 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 10 softgels in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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. 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 if you have 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 in children under 12 years of age Ask a doctor before use if you liver disease heart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if if you are taking the blood thinning drug warfarin.

When using this product do not exceed recommended dosage. Stop use and ask a doctor if • pain, 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. • nervousness, dizziness, or sleeplessness occurs If pregnant or breastfeeding, 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

🧪 Active Ingredient 7 words ▾

Active ingredient(s) Acetaminophen 325mg Dextromethorphan HBr 10mg

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White Edible Ink

🎯 Purpose 6 words ▾

Purpose Pain reliever/fever reducer Cough suppressant

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

🔗 Related NDC lookups

🧪 All Daytime Cold And Flu NDCsSame ingredient 🏭 All Allegiant labeler NDCsLabeler code 69168 📚 All Sigma-1 Agonist NDCsDrug class