Home › NDC Lookup › Ingredients › Dextromethorphan Hbr And Doxylamine Succ... › 72854-0083-32
📦image loading
(from DailyMed)

Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack Dextromethorphan HBr and Doxylamine Succinate Kit — NDC 72854-083-32 (Billing 72854-0083-32)

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

This is a package of Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack Dextromethorphan HBr and Doxylamine Succinate Kit from Reckitt Benckiser LLC, marketed since Jun 2024 and currently FDA-listed. It is this product's only package size.

NDC 72854-0083-32
🏷️ FDA NDC (as labeled) 72854-083-32 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 6, 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) 72854-083-32
Product NDC 72854-083
11-digit billing NDC 72854008332
NCPDP billing unit EA — each (per item)
RxCUI 2683423, 2683424, 2683425
Application # M012
SPL Set ID 16637d54-8049-d3ce-e063-6394a90aafc9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-03
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 2683423
Why two NDCs? The FDA registers this code as 72854-083-32 — 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 → 72854-0083-32. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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?

This is an over-the-counter combination kit containing two types of chewable tablets for children's cough relief. Dextromethorphan HBr is a cough suppressant typically used to reduce cough during the day, while doxylamine succinate is an antihistamine commonly used in nighttime formulas to help with cough and promote sleep. The kit provides separate daytime and nighttime options as an OTC monograph product, meaning it is marketed under FDA's established guidelines for this product category.

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
72854-0083-32 You're viewing this Main listing 1 KIT in 1 CARTON * 16 TABLET, CHEWABLE in 1 BOTTLE * 16 TABLET, CHEWABLE in 1 BOTTLE 2024-06-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Packthis 72854-0083-32 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

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

LabelerReckitt Benckiser LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code72854
First marketedJun 2024
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 85 words ▾

Uses Mucinex Children's Mighty Chews Cough Daytime: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold Mucinex Children's Mighty Chews Cough Nighttime: ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ controls cough to help you get to sleep ■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

⏱️ Dosage and Administration 91 words ▾

Directions Mucinex Children's Mighty Chews Cough Daytime+Mucinex Children's Mighty Chews Cough Nighttime:: ■ take every 4 hours or as directed by a doctor ■ chew thoroughly before swallowing ■ do not swallow whole adults and children 12 years of age and over 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period children 6 to under 12 years of age 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period children under 6 years of age do not use

⚠️ Warnings ~2 min read ▾

Mucinex Children's Mighty Chews Cough Daytime: Warnings Do not use 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 ■ a sodium-restricted diet ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema When using this product do not exceed recommended dosage Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache.

These could be signs of a serious condition. Mucinex Children's Mighty Chews Cough Nighttime: Warnings Do not use ■ to make a child sleepy ■ 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 ■ a sodium-restricted diet ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ 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 sedatives or tranquilizers When using this product ■ do not exceed recommended dosage ■ excitability may occur, especially in chidren ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

🧪 Active Ingredient 36 words ▾

Mucinex Children's Mighty Chews Cough Daytime: Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg Mucinex Children's Mighty Chews Cough Nighttime: Active ingredients (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

🧪 Inactive Ingredients 78 words ▾

Mucinex Children's Mighty Chews Cough Daytime: Inactive ingredients anhydrous citric acid, corn syrup, 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) Mucinex Children's Mighty Chews Cough Nighttime: Inactive ingredients anhydrous citric acid, corn syrup, 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 10 words ▾

Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant Doxylamine succinate 6.25 mg.................................................Antihistamine

📄 Keep Out of Reach of Children 34 words ▾

If pregnant or breast-feeding , 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 right away

📄 Other Information 24 words ▾

Other information ■ each chewable tablet contains: potassium 5 mg and sodium 15 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 16 words ▾

Mucinex Childrens Mighty Chews Cough Value Pack 1 Mucinex Childrens Mighty Chews Cough Value Pack 2

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 Cough Daytime and Nighttime Combo Pack (this brand).

Top reported reactions

Confusional State1
Delirium1
Hallucination1
Mental Status Changes1
Pneumonia1
Therapy Interrupted1

Reporter sex

0 reports

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 0
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 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.
← 72854-0082-16 · Reckitt 72854-0084-16 · RB →
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.