Home › NDC Lookup › Ingredients › Acetaminophen, Dextromethorphan Hydrobro... › 72854-0161-10
Mucinex Fast-Max Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide 325 mg; 10 mg Tablet, 10-count — NDC 72854-0161-10 package photo

Mucinex Fast-Max Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide 325 mg; 10 mg Tablet, 10-count

by Reckitt Benckiser LLC · 1 BLISTER PACK in 1 CARTON (72854-161-10) / 10 TABLET in 1 BLISTER PACK
NDC 72854-0161-10
🏷️ FDA NDC (as labeled) 72854-161-10 billing pads the product segment with a zero
This package
Contains10-count Pack sizes4 compare ↓
Also comes in: 2 tablets 72854-0161-02 4 tablets 72854-0161-04 20 tablets 72854-0161-20
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 72854-161-10
Product NDC 72854-161
11-digit billing NDC 72854016110
RxCUI 2709673
UNII 362O9ITL9D, 9D2RTI9KYH
UPC 0363824998923
Application # M012
SPL Set ID 31ac6883-ffcd-39de-e063-6294a90a52dd
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 2025-04-01
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 72854-161-10 — 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 → 72854-0161-10. 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

LabelerReckitt Benckiser LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code72854
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio174 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.

🩺 Clinical

🧪 What is this product?

Mucinex Fast-Max Cold and Flu is an over-the-counter tablet taken by mouth. It contains acetaminophen, which is typically used to reduce fever and relieve pain and aching, and dextromethorphan hydrobromide, which is commonly used as a cough suppressant. This product is marketed as a combination cold and flu remedy under the FDA's over-the-counter monograph system for such products.

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.

💊 What it looks like

Color red
ShapeOval
ImprintChevron
Size8 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 6T47AS764T
    Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statesInactive ingredients croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, 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 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 4 tablets 20 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
DayQuil Severe VapoCool Cold and Flu 325 mg/1; 10 mg 50269-0554-01 J.C. 2 tablets — — FDA listed —
Daytime Cold And Flu 325 mg/1; 10 mg 51316-0676-62 CVS 2 tablets — — FDA listed —
Pain, Headache and Cough 325 mg/1; 10 mg 51316-0803-09 CVS 10 tablets — — FDA listed —
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX 10 mg/1; 325 mg 66715-6204-02 Lil' 2 tablets — — FDA listed —
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), CVP 10 mg/1; 325 mg 66715-6804-02 Lil' 2 tablets — — FDA listed —
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), Lil Drug Store 10 mg/1; 325 mg 66715-9604-02 Lil' 2 tablets — — FDA listed —
Leader Vapor Ice Cold and Flu 325 mg/1; 10 mg 70000-0747-01 Cardinal 2 tablets — — FDA listed —
Foster and Thrive Daytime Cold and Flu Relief 325 mg/1; 10 mg 70677-1313-01 Strategic 2 tablets — — FDA listed —
Mucinex Fast-Max Cold and Flu 325 mg/1; 10 mgthis 72854-0161-10 Reckitt 10 tablets — — FDA listed —
Mucinex Rapid Clear Pain Headache and Cough 325 mg/1; 10 mg 72854-0215-20 Reckitt 20 tablets — — FDA listed —
Cold and Flu 325 mg/1; 10 mg 79903-0433-20 WALMART 10 tablets — — FDA listed —
Vicks DayQuil VapoCOOL COLD and FLU 325 mg/1; 10 mg 84126-0352-02 The 2 tablets — — FDA listed —
Good Sense Daytime 325 mg/1; 10 mg 00113-7019-53 L. 2 tablets — — FDA listed —
Equate Daytime Vapor Ice Cold and Flu 325 mg/1; 10 mg 79903-0416-24 WALMART 2 tablets — — FDA listed —
DayQuil Cold and Flu Vapo Cool Coated 325 mg/1; 10 mg 50269-0558-01 JC 2 tablets — — FDA listed —
Topcare Day Time Cold And Flu 325 mg/1; 10 mg 76162-0598-62 Topco 2 tablets — — FDA listed —
daytime cold and flu 325 mg/1; 10 mg 72288-0710-62 Amazon.com 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

🏛️
2025
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72854-0161-02 2 TABLET in 1 POUCH (72854-161-02) 2025-04-01 Active
72854-0161-04 2 POUCH in 1 CARTON (72854-161-04) / 2 TABLET in 1 POUCH 2025-04-01 Active
72854-0161-10 You're viewing this 1 BLISTER PACK in 1 CARTON (72854-161-10) / 10 TABLET in 1 BLISTER PACK 2025-04-01 Active
72854-0161-20 2 BLISTER PACK in 1 CARTON (72854-161-20) / 10 TABLET in 1 BLISTER PACK 2025-04-01 Active

Pack size FAQ

What quantity is in NDC 72854-0161-10?
NDC 72854-0161-10 is a 10-count package — 1 blister pack in 1 carton / 10 tablet in 1 blister pack.
What is the difference between NDC 72854-0161-10 and NDC 72854-0161-02?
Both are Mucinex Fast-Max Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide 325 mg; 10 mg Tablet — the drug itself is identical. NDC 72854-0161-10 is the 10-count package, while NDC 72854-0161-02 is the 2 tablets package.
What NDC number is used to bill for this package of Mucinex Fast-Max Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide 325 mg; 10 mg Tablet?
Bill NDC 72854-0161-10 — the 11-digit billing format is 72854016110. 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 72854-161-10, 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: 72854-0161-10, written without dashes as 72854016110. 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 72854-0161-10, the first segment (72854) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0161) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Reckitt Benckiser 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 3 other package presentations of this same product, including 2 tablets (72854-0161-02), 4 tablets (72854-0161-04), 20 tablets (72854-0161-20). 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?
Reckitt Benckiser 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.

📄 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 60 words ▾

Uses Uses ■ temporarily relieves these common cold and flu symptoms: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ minor aches and pains ■ sore throat ■ headache ■ temporarily reduces fever

⏱️ Dosage and Administration 50 words ▾

Directions Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 caplets in any 24-hour period ■ adults and children 12 years of age and over: take 2 caplets every 4 hours ■ children under 12 years of age: do not use

⚠️ Warnings ~2 min read ▾

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 for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily 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. 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 use more than directed 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. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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 10 words ▾

Acetaminophen 325 mg...Pain reliever/fever reducer Dextromethorphan HBr 10 mg...Cough suppressant

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

🎯 Purpose 10 words ▾

Acetaminophen » Pain Reliever/Fever Reducer Dextromethorphan HBr » Cough Suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72854-0160-26 · Reckitt 72854-0162-20 · Reckitt →
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.