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Medique Cold Cough Product Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , 10 mg; 325 mg; 5 mg Tablet, Film Coated — NDC 47682-0108-80 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Medique Cold Cough Product Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , 10 mg; 325 mg; 5 mg Tablet, Film Coated — NDC 47682-108-80 (Billing 47682-0108-80)

by Unifirst First Aid Corporation · 40 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET

This is a package of Medique Cold Cough Product Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , 10 mg; 325 mg; 5 mg Tablet, Film Coated from Unifirst First Aid Corporation, marketed since Sep 2022 and currently FDA-listed.

NDC 47682-0108-80
🏷️ FDA NDC (as labeled) 47682-108-80 billing pads the product segment with a zero
This package
Contains2 tablet, film coated in 1 packet Pack sizes3 compare ↓
Product page 47682-0108-36 Also comes in: 2 tablets 47682-108-36 2 tablets 47682-108-99
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

NDC database record

One package, one record: these facts belong to NDC 47682-108-80 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
47682 labeler · 108 product · 80 package
Package marketed since
Sep 26, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0347682108809
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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
Quick answers
  • RxCUI (RxNorm): 1094538
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.

Clinical

🧪 What is this product?

Medique Cold Cough Product is an over-the-counter film-coated tablet taken by mouth that combines three active ingredients commonly used to manage cold and cough symptoms. Acetaminophen is typically used to reduce fever and relieve pain, while dextromethorphan is commonly used as a cough suppressant. Phenylephrine functions as a nasal decongestant to help relieve congestion. This is an OTC monograph product, meaning it is marketed under FDA's established category rules for over-the-counter cold and cough medicines.

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.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
47682-0108-36 47682-108-36 Main listing 75 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET 2022-12-12 — Active
47682-0108-80 You're viewing this 40 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET 2022-09-26 — Active
47682-0108-99 47682-108-99 2 TABLET, FILM COATED in 1 PACKET 2022-09-26 — Active

Pack size FAQ

What quantity is in this package?
This package 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?
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
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.

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.

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

LabelerUnifirst First Aid Corporation
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code47682
First marketedSep 2022
Product typeHuman Otc Drug
Portfolio183 products on file

More NDCs from Unifirst First Aid Corporation labeler code 47682

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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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

📄 Do Not Use 77 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist.

📄 Ask a Doctor Before Use If 54 words ▾

Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ 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 dosage.

📄 Stop Use and Ask a Doctor If 64 words ▾

Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain gets worse or lasts for 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 53 words ▾

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Other Information 26 words ▾

Other information ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) ■ tamper evident sealed packets ■ do not use any opened or torn packets

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-634-7680

📄 Package Label / Principal Display Panel 43 words ▾

Medique® Cold & Cough Product Multi-Symptom Relief Pull to Open Pain Reliever/Fever Reducer • Acetaminophen 325 mg Cough Suppressant • Dextromethorphan HBr 10 mg Nasal Decongestant • Phenylephrine HCl 5 mg 80 Caplets (40 x 2) Tamper Evident Unit Dose Packets 108R Cold

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

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 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.
← 47682-0075-73 · UniFirst 47682-0110-03 · Unifirst →
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.