Childrens Mucinex Multi-Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL Solution — NDC 63824-0282-67 package photo

Childrens Mucinex Multi-Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL Solution

by Reckitt Benckiser LLC · 1 BOTTLE in 1 CARTON (63824-282-67) / 201 mL in 1 BOTTLE
NDC 63824-0282-67
🏷️ FDA NDC (as labeled) 63824-282-67 billing pads the product segment with a zero
This package
Contains201 mL in 1 bottle Pack sizes3 compare ↓
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 63824-282-67
Product NDC 63824-282
11-digit billing NDC 63824028267
NCPDP billing unit ML — per mL (volume)
RxCUI 1043543
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID 60daf6e2-ded8-44e6-bd8d-9d221384adde
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-07-17
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
GPI-14 43997303100960
GPI class Mucinex Cold Childrens
GCN Seq No 066559
GCN 28875
HICL code 000216
Ingredient (HICL) Guaifen/Dextromethorphan/Pe
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 B4R
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Decongestant-Expectorant
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name CHILD MUCINEX MULTI-SYMPTOM LQ
FDB brand name Children's Mucinex
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 63824-282-67 — 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 → 63824-0282-67. 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.

🏭 Manufacturer & labeler

LabelerReckitt Benckiser LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63824
First marketedJul 2012
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 CHILD MUCINEX MULTI-SYMPTOM LQ Ingredient Guaifen/Dextromethorphan/Pe
🧪 What is this product?

Childrens Mucinex Multi-Symptom Cold is an over-the-counter liquid solution taken by mouth that contains three active ingredients commonly used in cold symptom products. Guaifenesin functions as an expectorant, typically used to help loosen mucus and make cough easier to manage. Dextromethorphan is a cough suppressant typically used to reduce coughing, while phenylephrine is a decongestant commonly used to help relieve nasal congestion. This product is marketed under the FDA's OTC drug monograph rules for cough and cold medicines.

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 pink
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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesanhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient, xanthan gum

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 DailyMedingredient 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 mLPer 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: 118 mL 118 mL
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
Leader Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 70000-0629-01 CARDINAL 1 bottle $0.047 Availability likely
Mucinex Fast-Max Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0540-66 Reckitt 180 ml $0.060 FDA listed
Mucinex Childrens Multi-Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0949-01 Reckitt 1 bottle $0.070 FDA listed
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0956-64 Reckitt 1 bottle $0.070 FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0337-06 Walgreens 177 ml FDA listed
Mucus Congestion and Cough Relief Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-0512-06 Walgreens 1 bottle FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0681-06 Walgreens 177 ml FDA listed
Childrens Mucus Cough and Congestion Relief 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-1056-88 Walgreen 1 bottle FDA listed
Walgreen Maximum Strength Severe Congestion and cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-7389-09 WALGREENS 266 ml FDA listed
Walgreens Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-7760-06 WALGREEN 180 ml FDA listed
Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-8004-45 Walgreen 177 ml FDA listed
Childrens Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-9057-36 Walgreen 1 bottle FDA listed
Mucus Relief Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0337-06 TARGET 177 ml FDA listed
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0738-06 Target 177 ml FDA listed
SIGNATURE CARE Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 21130-0162-04 SAFEWAY 1 bottle FDA listed
Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0738-06 SAFEWAY 180 ml FDA listed
Kroger Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 30142-0738-06 KROGER 180 ml FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 36800-0037-06 TOP 177 ml FDA listed
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 37808-0317-25 H 177 ml FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0047-06 United 177 ml FDA listed
maximum strength mucus relief severe congestion and cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0738-06 SuperValu 180 ml FDA listed
Childrens Multi-Symptom Cold 5 mg/5mL; 2.5 mg/5mL; 100 mg/5mL 41226-0937-05 Kroger 1 bottle FDA listed
Meijer Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41250-0446-06 MEIJER, 180 ml FDA listed
Maximum Strength Mucus Relief Severe Congestion and Cough Cooling Menthol 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41250-0776-06 MEIJER 180 ml FDA listed
Childrens Multi-symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 49035-0715-03 Wal-Mart 118 ml FDA listed
Maximum Strength Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0774-06 Wal-Mart 180 ml FDA listed
Maximum Strength Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0976-06 Wal-Mart 180 ml FDA listed
Tukol MAX ACTION Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50066-0517-25 Genomma 177 ml FDA listed
Severe Congestion and Cough Relief Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50844-0004-45 L.N.K. 177 ml FDA listed
Childrens Multi Symptom Cold Very Berry 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 51316-0815-03 CVS 118 ml FDA listed
Childrens Tussnex Multi-symptom cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 53041-0615-03 Guardian 1 bottle FDA listed
Tussnex FM Severe cough and congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53041-0617-58 Guardian 177 ml FDA listed
Mucosan Severe Multi-Symptom 10 mg/20mL; 20 mg/20mL; 400 mg/20mL 53145-0697-06 Menper 1 bottle FDA listed
SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53942-0517-25 DeMoulas 177 ml FDA listed
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53943-0517-25 Discount 177 ml FDA listed
Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55319-0204-45 Family 177 ml FDA listed
SanaTos Turbo Max Strength 10 mg/20mL; 20 mg/20mL; 400 mg/20mL 55758-0322-06 Pharmadel 177 ml FDA listed
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0037-09 Dolgencorp, 266 ml FDA listed
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0537-06 Dolgencorp, 177 ml FDA listed
Childrens Mucinex Multi-Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mLthis 63824-0282-67 Reckitt 1 bottle FDA listed
Mucinex Childrens Cough and Congestion 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0947-11 Reckitt 1 bottle FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63868-0745-06 QUALITY 177 ml FDA listed
Severe Congestion and Cough Max 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63941-0517-25 Best 177 ml FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 68163-0738-09 Raritan 266 ml FDA listed
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69256-0337-06 Harris 177 ml FDA listed
Cold Childrens, Multi Symptom 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 69842-0570-88 CVS 1 bottle FDA listed
Congestion and Cough Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 69842-0756-88 CVS 1 bottle FDA listed
CVS Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0767-06 CVS 180 ml FDA listed
Severe Cough and Congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0942-45 CVS 177 ml FDA listed
AMAZON Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 72288-0649-04 AMAZON.COM 1 bottle FDA listed
Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0040-45 TOPCO 177 ml FDA listed
Mucus Relief Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 76162-0057-88 TOPCO 1 bottle FDA listed
SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76281-0517-25 AptaPharma 177 ml FDA listed
Multi-Symptom Cold childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 79903-0176-06 WALMART 1 bottle FDA listed
Childrens Multi-symptom Cold Daytime 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 79903-0270-03 Wal-Mart 1 bottle FDA listed
Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 83324-0077-06 Chain 177 ml FDA listed
QCH Maximum Strength Mucus Relief 617 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 83324-0144-06 Chain 177 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

🏛️
2012
On the market since
Jul 2012
📍
2026
Currently FDA-listed
14 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
63824-0282-22 2 CARTON in 1 CELLO PACK (63824-282-22) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2012-07-17 Discontinued by firm
63824-0282-64 1 BOTTLE in 1 CARTON (63824-282-64) / 118 mL in 1 BOTTLE 2012-07-17 Discontinued by firm
63824-0282-67 You're viewing this 1 BOTTLE in 1 CARTON (63824-282-67) / 201 mL in 1 BOTTLE 2012-07-17 Active

Pack size FAQ

What quantity is in NDC 63824-0282-67?
NDC 63824-0282-67 is listed by the FDA — 1 bottle in 1 carton / 201 ml in 1 bottle.
What NDC number is used to bill for this package of Childrens Mucinex Multi-Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL Solution?
Bill NDC 63824-0282-67 — the 11-digit billing format is 63824028267. 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 63824-282-67, 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: 63824-0282-67, written without dashes as 63824028267. 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 63824-0282-67, the first segment (63824) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0282) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (67) 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 2 other package presentations of this same product, including 1 cello (63824-0282-22), 1 bottle (63824-0282-64). 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 65 words

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: 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 your child get to sleep nasal congestion due to a cold stuffy nose

⏱️ Dosage and Administration 71 words

Directions 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 mL = milliliter Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use

⚠️ Warnings 173 words

Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 33 words

Other information each 5 mL contains: sodium 3 mg tamper evident: do not use if neckband on bottle cap is broken or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided

🧪 Active Ingredient 23 words

Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 mg Nasal decongestant

🧪 Inactive Ingredients 32 words

Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum

🎯 Purpose 23 words

Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 mg Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.