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Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride Kit

by Reckitt Benckiser LLC · 1 KIT in 1 CARTON (63824-505-26) * 180 mL in 1 BOTTLE (63824-504-66) * 180 mL in 1 BOTTLE (63824-548-66)
NDC 63824-0505-26
🏷️ FDA NDC (as labeled) 63824-505-26 billing pads the product segment with a zero
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) 63824-505-26
Product NDC 63824-505
11-digit billing NDC 63824050526
NCPDP billing unit ML — per mL (volume)
RxCUI 1116572, 2173662, 2637727
Application # M012
SPL Set ID 29571047-4c4b-44ca-8726-57c28308e8cf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-19
Dosage form KIT
GPI-14 4399880555C425
GPI class Mucinex Fast-Max Day/Night MS
GCN Seq No 081820
GCN 49048
HICL code 046412
Ingredient (HICL) Triprolidine/Pe/Dm/Acetamin/Gg
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4O
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Antihist-Decon-Analg-Expect
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name MUCINEX FASTMAX COLD-NTSHFT LQ
FDB brand name Mucinex Fast-Max Cold-Nghtshft
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 63824-505-26 — 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 → 63824-0505-26. 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 code63824
First marketedJun 2020
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

Label name MUCINEX FASTMAX COLD-NTSHFT LQ Ingredient Triprolidine/Pe/Dm/Acetamin/Gg
🧪 What is this product?

This is an over-the-counter combination kit containing two liquid cold and flu products. Maximum Strength Mucinex Fast-Max Cold and Flu contains acetaminophen (commonly used to reduce fever and relieve pain), dextromethorphan (typically used to suppress cough), guaifenesin (commonly used to thin mucus and ease congestion), and phenylephrine (typically used as a nasal decongestant). Mucinex NightShift Severe Cold and Flu includes these same ingredients plus triprolidine, an antihistamine often used to help relieve allergy and cold symptoms. The kit is marketed under FDA's over-the-counter drug rules for cold and flu products.

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.

🧪 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.

From the label’s inactive-ingredient sectionanhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient, xanthan gum ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength 72854-0241-10 Reckitt 6 tablets $0.563 — FDA listed —
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus 63824-0115-66 Reckitt 1 kit — — FDA listed —
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu 63824-0117-66 Reckitt 1 kit — — FDA listed —
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength 72854-0242-40 Reckitt 6 tablets — — FDA listed —
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu 72854-0154-26 Reckitt 1 kit — — FDA listed —
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu 72854-0166-26 Reckitt 1 kit — — FDA listed —
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Fluthis 63824-0505-26 Reckitt 1 kit — — 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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 NDCDescription Marketing startStatus
63824-0505-26 You're viewing this 1 KIT in 1 CARTON (63824-505-26) * 180 mL in 1 BOTTLE (63824-504-66) * 180 mL in 1 BOTTLE (63824-548-66) 2022-05-30 Active

🧭 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) ✓ 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 63824-505-26, 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: 63824-0505-26, written without dashes as 63824050526. 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 63824-0505-26, the first segment (63824) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0505) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (26) 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.
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 109 words ▾

Uses MUCINEX FAST-MAX COLD & FLU temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache stuffy nose sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive MUCINEX NIGHTSHIFT SEVERE COLD & FLU temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache sneezing sinus congestion and pressure runny nose itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep

⏱️ Dosage and Administration 154 words ▾

Directions MUCINEX FAST-MAX COLD & FLU do not take more than directed (see Overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use MUCINEX NIGHTSHIFT SEVERE COLD & FLU do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided 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 4000 mg in 24 hours, which is the maximum daily amount 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 heart disease diabetes high blood pressure thyroid disease glaucoma (Nightshift Severe Cold & Flu only) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis (Nightshift Severe Cold & Flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 taking sedatives or tranquilizers (Nightshift Severe Cold & Flu only) When using this product do not use more than directed excitability may occur, especially in children (Nightshift Severe Cold & Flu only) marked drowsiness may occur (Nightshift Severe Cold & Flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only) avoid alcoholic drinks (Nightshift Severe Cold & Flu only) use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 fever, rash, or headache that lasts.

These could be signs of a serious condition. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 31 words ▾

Other information each 20 mL contains: sodium 12 mg (Fast-Max Cold & Flu only) and sodium 16 mg (Nightshift Severe Cold & Flu only) store at 20-25°C (68-77°F) do not refrigerate

🧪 Active Ingredient 70 words ▾

Active ingredients (in each 20 mL) MUCINEX FAST-MAX COLD & FLU Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant Active ingredients (in each 20 mL) MUCINEX NIGHTSHIFT SEVERE COLD & FLU Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal decongestant Triprolidine HCl 2.5 mg Antihistamine

🧪 Inactive Ingredients 82 words ▾

Inactive ingredients (MUCINEX FAST-MAX COLD & FLU) anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum

Inactive ingredients (MUCINEX NIGHTSHIFT SEVERE COLD & FLU) ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

🎯 Purpose 70 words ▾

Active ingredients (in each 20 mL) MUCINEX FAST-MAX COLD & FLU Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant Active ingredients (in each 20 mL) MUCINEX NIGHTSHIFT SEVERE COLD & FLU Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal decongestant Triprolidine HCl 2.5 mg Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63824-0504-66 · Reckitt 63824-0514-01 · 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.