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Mucinex Childrens Mighty Chews Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 5 mg; 3.125 mg; 162.5 mg Tablet, Chewable, 16-count — NDC 72854-0085-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mucinex Childrens Mighty Chews Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 5 mg; 3.125 mg; 162.5 mg Tablet, Chewable, 16-count — NDC 72854-085-16 (Billing 72854-0085-16)

by Reckitt Benckiser LLC · 16 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 16 tablets of Mucinex Childrens Mighty Chews Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 5 mg; 3.125 mg; 162.5 mg Tablet, Chewable from Reckitt Benckiser LLC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 72854-0085-16
🏷️ FDA NDC (as labeled) 72854-085-16 billing pads the product segment with a zero
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) 72854-085-16
Product NDC 72854-085
11-digit billing NDC 72854008516
RxCUI 2715863
UNII 9D2RTI9KYH, V9BI9B5YI2, 362O9ITL9D
UPC 0363824999623
Application # M012
SPL Set ID 2ce31244-9c6c-b7dd-e063-6394a90a31a8
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine Receptor Antagonists; 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 2025-06-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 2715863
Why two NDCs? The FDA registers this code as 72854-085-16 — 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 → 72854-0085-16. 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?

Mucinex Childrens Mighty Chews Night Time Cold and Flu is a chewable tablet containing three active ingredients. Acetaminophen is typically used to reduce fever and relieve minor aches and pain. Dextromethorphan is commonly used as a cough suppressant. Doxylamine succinate functions as a nighttime sleep aid. This is an over-the-counter monograph product formulated for children's use.

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.
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
72854-0085-16 You're viewing this Main listing 16 TABLET, CHEWABLE in 1 BOTTLE 2025-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucinex Childrens Mighty Chews Night Time Cold and Flu 5 mg/1; 3.125 mg/1; 162.5 mgthis 72854-0085-16 Reckitt 16 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
Jun 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.

What it looks like

Color purple
ShapeRound
ImprintM
Size23 mm
ScoringNot scored
FlavorBerry
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 817L1N4CKP
    Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 89NA02M4RX
    Pectin is a natural fiber extracted from fruit and plants. It's used in medicines as a thickener, binder, and gelling agent to create the right texture and help the product hold together.
  • UNII QH257BPV3J
    A salt compound made from tartaric acid, used in medicines as a buffering agent to help stabilize the pH and sometimes as a mild laxative filler in formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII P1BM4ZH95L
    A salt derived from phosphoric acid, sodium polymetaphosphate acts as a sequestrant and buffering agent in medicines. It helps maintain stability and control acidity in liquid formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesInactive ingredients anhydrous citric acid, corn syrup, ethylcellulose, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, sodium polymetaphosphate, sucralose, sucrose, trisodium citrate (anhydrous)

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.

Manufacturer & labeler

LabelerReckitt Benckiser LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code72854
First marketedJun 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.

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep

⏱️ Dosage and Administration 89 words ▾

Directions ■ do not take more than directed (see Overdose warning) ■ chew thoroughly before swallowing ■ dose every 4 hours or as directed by a doctor adults and children 12 years of age and over 4 chewable tablets every 4 hours, not to exceed 6 doses (24 chewable tablets) in any 24-hour period children 6 to under 12 years of age 2 chewable tablets every 4 hours, not to exceed 5 doses (10 chewable tablets) in any 24-hour period children under 6 years of age do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: ■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 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 ■ to make a child sleepy ■ 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 the user is 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 ■ has liver disease ■ has a sodium-restricted diet ■ has glaucoma ■ has a breathing problem such as emphysema or chronic bronchitis ■ has difficulty in urination due to enlargement of the prostate gland ■ is a child with pain of arthritis Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed (see Overdose warning) ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ■ 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.

🧪 Active Ingredient 11 words ▾

Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 mg

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients anhydrous citric acid, corn syrup, ethylcellulose, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, sodium polymetaphosphate, sucralose, sucrose, trisodium citrate (anhydrous)

🎯 Purpose 15 words ▾

Acetaminophen 162.5 mg................................................Pain reliever/fever reducer Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant Doxylamine succinate 3.125 mg.................................................Antihistamine

📄 Keep Out of Reach of Children 67 words ▾

If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Other Information 24 words ▾

Other information ■ each chewable tablet contains: potassium 5 mg and sodium 13 mg ■ Store in a cool dry place at 20-25°C (68-77°F)

📄 Questions or Comments 3 words ▾

Questions? 1-866-MUCINEX (1-866-682-4639)

📄 Package Label / Principal Display Panel 24 words ▾

NDC 72854-085-16 Children's Mucinex® Cough Suppressant Antihistamine Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 m Age 6+ Mixed Berry Flavor Label

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 Mucinex Childrens Mighty Chews Night Time Cold and Flu (this brand).

Top reported reactions

Fatigue1
Hypersensitivity1
Seasonal Allergy1

Age at onset

Elderly1

Reporter sex

1 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) ✓ 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 Reckitt Benckiser LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
← 72854-0084-16 · RB 72854-0090-12 · 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.