NDC 47682-0108-80 — Medique Cold Cough Product Acetaminophen

🆔 Identity & classification

FDA NDC (as labeled) 47682-108-80

Product NDC 47682-108

11-digit billing NDC 47682010880

RxCUI 1094538

UNII 9D2RTI9KYH, 362O9ITL9D, 04JA59TNSJ

UPC 0347682108809

Application # M012

SPL Set ID e8059137-efba-398c-e053-2a95a90a21f2

Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist

Mechanism of action Adrenergic alpha1-Agonists; 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 2022-09-26

Route ORAL

Dosage form TABLET, FILM COATED

Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 47682-108-80 — 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 → 47682-0108-80. 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

LabelerUnifirst First Aid Corporation

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code47682

First marketedSep 2022

Product typeHuman Otc Drug

Portfolio179 products on file

🔎 All NDCs from Unifirst First Aid Corporation

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?

Medique Cold Cough Product is an oral film-coated tablet containing three active ingredients commonly used to relieve cold and cough symptoms. Acetaminophen is typically used as a pain reliever and fever reducer. Dextromethorphan is commonly used to suppress cough. Phenylephrine is typically used as a nasal decongestant to help relieve stuffiness. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this product category.

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.

💊 What it looks like

Color white

ShapeCapsule

ImprintAZ;324

Size17 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesInactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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.

Try another pack size: 2 tablets 2 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Multi-Symptom Mapap Cold Formula 325 mg/1; 10 mg/1; 5 mg 00904-5786-24	Major	12 tablets	$0.094	—	Availability likely	—
Cold Max 5 mg/1; 325 mg/1; 10 mg 46122-0410-62	AmeriSource	12 tablets	$0.094	—	Availability likely	—
Cold Relief Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 70000-0652-01	Cardinal	12 tablets	$0.094	—	Availability likely	—
Theraflu ExpressMax Daytime Severe Cold and Cough 325 mg/1; 10 mg/1; 5 mg 00067-8136-10	Haleon	10 tablets	—	—	FDA listed	—
Cold Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 30142-0470-08	Kroger	12 tablets	—	—	FDA listed	—
Cold plus Head Congestion 325 mg/1; 10 mg/1; 5 mg 36800-0514-02	TOPCO	12 tablets	—	—	FDA listed	—
Cold Max 325 mg/1; 10 mg/1; 5 mg 36800-0521-05	TOPCO	12 tablets	—	—	FDA listed	—
Cold Max Daytime 10 mg/1; 5 mg/1; 325 mg 36800-0921-05	TopCo	12 tablets	—	—	FDA listed	—
Cold Plus Head Congestion Daytime 325 mg/1; 10 mg/1; 5 mg 36800-0924-02	TopCo	12 tablets	—	—	FDA listed	—
Cold Relief 325 mg/1; 10 mg/1; 5 mg 41163-0907-08	United	12 tablets	—	—	FDA listed	—
Cold Multi-Symptom Daytime 325 mg/1; 10 mg/1; 5 mg 41520-0138-05	American	12 tablets	—	—	FDA listed	—
Cold Head Congestion Daytime 325 mg/1; 10 mg/1; 5 mg 41520-0603-02	American	12 tablets	—	—	FDA listed	—
Medique Cold Cough Product 10 mg/1; 325 mg/1; 5 mgthis 47682-0108-80	Unifirst	2 tablets	—	—	FDA listed	—
Cold Max 325 mg/1; 10 mg/1; 5 mg 53943-0138-05	DISCOUNT	12 tablets	—	—	FDA listed	—
Cold Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 55301-0470-08	ARMY	12 tablets	—	—	FDA listed	—
Multi-Symptom Mapap Cold Formula 325 mg/1; 10 mg/1; 5 mg 63187-0652-24	Proficient	12 tablets	—	—	FDA listed	—
Multi-Symptom Cold Daytime 325 mg/1; 10 mg/1; 5 mg 63941-0470-08	Valu	12 tablets	—	—	FDA listed	—
Non-Drowsy Max Cold 10 mg/1; 325 mg/1; 5 mg 66715-5628-03	Lil'	2 tablets	—	—	FDA listed	—
Cold Max 325 mg/1; 10 mg/1; 5 mg 68998-0238-05	MARC	12 tablets	—	—	FDA listed	—
Cold Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 69168-0324-86	Allegiant	12 tablets	—	—	FDA listed	—
Cold Max 325 mg/1; 10 mg/1; 5 mg 72036-0138-05	Harris	12 tablets	—	—	FDA listed	—
Medique Cold Cough Product 10 mg/1; 325 mg/1; 5 mg 85766-0162-36	Sportpharm	2 tablets	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2022

On the market since

Sep 2022

📍

2026

Currently FDA-listed

4 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
47682-0108-36	75 PACKET in 1 BOX (47682-108-36) / 2 TABLET, FILM COATED in 1 PACKET	2022-12-12	Active
47682-0108-80 You're viewing this	40 PACKET in 1 BOX (47682-108-80) / 2 TABLET, FILM COATED in 1 PACKET (47682-108-99)	2022-09-26	Active
47682-0108-99	2 TABLET, FILM COATED in 1 PACKET (47682-108-99)	2022-09-26	Active

Pack size FAQ

What quantity is in NDC 47682-0108-80?

NDC 47682-0108-80 is listed by the FDA — 40 packet in 1 box / 2 tablet, film coated in 1 packet.

What NDC number is used to bill for this package of Medique Cold Cough Product Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , 10 mg; 325 mg; 5 mg Tablet, Film Coated?

Bill NDC 47682-0108-80 — the 11-digit billing format is 47682010880. 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	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 47682-108-80, 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: 47682-0108-80, written without dashes as 47682010880. 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 47682-0108-80, the first segment (47682) is the labeler code FDA assigned to Unifirst First Aid Corporation; the middle segment (0108) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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 Unifirst First Aid Corporation. 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 2 tablets (47682-0108-36), 2 tablets (47682-0108-99). 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?

Unifirst First Aid Corporation 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 44 words ▾

Uses temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever.

⏱️ Dosage and Administration 66 words ▾

Directions do not take more than directed (see Warnings ) Adults and children: (12 years and over) ■ take 2 caplets every 4 hours ■ do not take more than 12 caplets in 24 hours Children under 12 years: do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.

⚠️ Warnings 107 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 caplets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause a severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help immediately.

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.

🧪 Active Ingredient 16 words ▾

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine Hydrochloride 5 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

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

🔗 Related NDC lookups

🧪 All Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl , NDCsSame ingredient 🏭 All Unifirst labeler NDCsLabeler code 47682 📚 All Sigma-1 Agonist NDCsDrug class