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Mucinex Nightshift Sinus Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride 20 mg/20mL; 10 mg/20mL; 2.5 mg/20mL; 650 mg/20mL Solution, 180 mL

by Reckitt Benckiser LLC · 180 mL in 1 BOTTLE (63824-269-66)
NDC 63824-0269-66
🏷️ FDA NDC (as labeled) 63824-269-66 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 63824-269-66
Product NDC 63824-269
11-digit billing NDC 63824026966
NCPDP billing unit ML — per mL (volume)
RxCUI 2173662
UNII 9D2RTI9KYH, 04JA59TNSJ, YAN7R5L890, 362O9ITL9D
UPC 0363824262680
Application # M012
SPL Set ID 6189fb89-a7d7-4ae6-a9e8-d9512acc0f55
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 2019-06-15
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE; ACETAMINOPHEN
GPI-14 43995904222020
GPI class Mucinex Nightshift Sinus
GCN Seq No 080843
GCN 47825
HICL code 046408
Ingredient (HICL) Triprolid/Phenyleph/Dm/Acetam
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3P
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1Stgen Antihist-Decon-Analgesic
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name MUCINEX NIGHTSHIFT SINUS LIQ
FDB brand name Mucinex Nightshift Sinus
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 63824-269-66 — 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 → 63824-0269-66. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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 2019
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 NIGHTSHIFT SINUS LIQ Ingredient Triprolid/Phenyleph/Dm/Acetam
🧪 What is this product?

Mucinex Nightshift Sinus is an oral liquid medicine sold over the counter under FDA's OTC monograph rules. It combines four active ingredients: acetaminophen, typically used to relieve pain and reduce fever; dextromethorphan, commonly used to suppress cough; phenylephrine, typically used to relieve nasal congestion; and triprolidine, an antihistamine commonly used to reduce allergy symptoms and promote drowsiness. This formulation is designed as a nighttime cold and sinus product intended to address multiple symptoms at once.

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.

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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $0.059 $10.53 / 180 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Apr 2022 Feb 2024 $0.064 $0.057
▲ Up 2% over the last 3 months.
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 Nightshift Sinus 20 mg/20mL; 10 mg/20mL; 2.5 mg/20mL; 650 mg/20mLthis 63824-0269-66 Reckitt 180 ml $0.058 — FDA listed —
Mucinex Nightshift Severe Cold and Flu 650 mg/20mL; 20 mg/20mL; 10 mg/20mL; 2.5 mg/20mL 63824-0504-66 Reckitt 180 ml $0.058 — FDA listed —
Cold and Flu Severe 650 mg/20mL; 20 mg/20mL; 10 mg/20mL; 2.5 mg/20mL 00363-8078-45 Walgreen 177 ml — — FDA listed —
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime 325 mg/10mL; 10 mg/10mL; 5 mg/10mL; 1.25 mg/10mL 63824-0959-64 Reckitt 1 bottle — — FDA listed —
CVS Overnight Cold and Flu Clear and Cool 650 mg/20mL; 20 mg/20mL; 10 mg/20mL; 2.5 mg/20mL 69842-0966-06 CVS 180 ml — — FDA listed —
Mucinex Night Time Severe Cold and Flu 650 mg/20mL; 20 mg/20mL; 10 mg/20mL; 2.5 mg/20mL 72854-0140-66 Reckitt 180 ml — — 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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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
63824-0269-66 You're viewing this 180 mL in 1 BOTTLE (63824-269-66) 2019-06-15 Active

🧭 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 — 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) ✓ Available
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.
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 63824-269-66, 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: 63824-0269-66, written without dashes as 63824026966. 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 63824-0269-66, the first segment (63824) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0269) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (66) 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 50 words ▾

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache sinus congestion and pressure runny nose sneezing 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 72 words ▾

Directions 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 older: 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 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 the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed excitability may occur, especially in children 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 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 16 words ▾

Other information each 20 mL contains: sodium 16 mg store at 20-25°C (68-77°F) do not refrigerate

🧪 Active Ingredient 30 words ▾

Active ingredients (in each 20 mL) 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 34 words ▾

Inactive ingredients 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 30 words ▾

Active ingredients (in each 20 mL) 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 ↗
← 63824-0266-66 · Reckitt 63824-0282-22 · 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.