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Cepacol Extra Strength Sore Throat and Cough BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE 5 mg; 7.5 mg Lozenge, 16-count — NDC 63824-744-16 (Billing 63824-0744-16)

by Reckitt Benckiser LLC · 2 BLISTER PACK in 1 CARTON / 8 LOZENGE in 1 BLISTER PACK

This is a package of 16 lozenges of Cepacol Extra Strength Sore Throat and Cough BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE 5 mg; 7.5 mg Lozenge from Reckitt Benckiser LLC, marketed since May 2014 and currently FDA-listed; retail pharmacies pay about $0.1508 per lozenge (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 63824-0744-16
🏷️ FDA NDC (as labeled) 63824-744-16 billing pads the product segment with a zero
This package
Contains16-count Cost per ea$0.1508 NADAC Per package$2.41 / 16 lozenges Pack sizes3 compare ↓
Main listing for product 63824-744 · Also comes in: 4 lozenges 63824-744-94 36 lozenges 63824-744-36
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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) 63824-744-16
Product NDC 63824-744
11-digit billing NDC 63824074416
NCPDP billing unit EA — each (per item)
RxCUI 1039251, 1039255
UNII 9D2RTI9KYH, U3RSY48JW5
UPC 0363824740164
Application # M012
SPL Set ID c0cc32db-90f0-4106-8538-89821083ece1
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-05-05
Route ORAL
Dosage form LOZENGE
Substance DEXTROMETHORPHAN HYDROBROMIDE; BENZOCAINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 88209902204725
GPI class Cepacol Sore Throat & Cough
GCN Seq No 063802
GCN 99512
HICL code 001911
Ingredient (HICL) Dextromethorphan/Benzocaine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6C
Therapeutic class — specific (HIC3) Antitussives, Non-Opioid
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name CEPACOL SORE THROAT-COUGH LOZ
FDB brand name Cepacol Sore Throat-Cough
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 063802
  • GCN: 99512
  • GPI-14 (Medi-Span): 88209902204725
  • HICL (First Databank): 001911
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 1039251
Why two NDCs? The FDA registers this code as 63824-744-16 — 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 → 63824-0744-16. 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 Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
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

Label name CEPACOL SORE THROAT-COUGH LOZ Ingredient Dextromethorphan/Benzocaine
🧪 What is this product?

Cepacol Extra Strength Sore Throat and Cough is an over-the-counter lozenge containing two active ingredients. Benzocaine is a local anesthetic typically used to numb minor throat pain, while dextromethorphan hydrobromide is a cough suppressant commonly used to reduce cough. This combination product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of throat lozenges rather than undergoing individual application review.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.151 $2.41 / 16 lozenges
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 ea) — tap or hover for the price & month
Nov 2021 Apr 2022 Dec 2023 $0.152 $0.150
Flat 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
63824-0744-16 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 8 LOZENGE in 1 BLISTER PACK $0.1508 / ea $2.41 2014-05-05 — Active
63824-0744-36 63824-744-36 3 BLISTER PACK in 1 CARTON / 12 LOZENGE in 1 BLISTER PACK — — 2019-05-01 — Discontinued by firm
63824-0744-94 63824-744-94 1 BLISTER PACK in 1 CARTON / 4 LOZENGE in 1 BLISTER PACK — — 2014-05-05 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This is a 16-count package — 2 blister pack in 1 carton / 8 lozenge in 1 blister pack.
How does this package differ from NDC 63824-0744-94?
Both are Cepacol Extra Strength Sore Throat and Cough BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE 5 mg; 7.5 mg Lozenge — the drug itself is identical. This page's package is the 16-count one, while NDC 63824-0744-94 is the 4 lozenges package.
What NDC number is used to bill for this package of Cepacol Extra Strength Sore Throat and Cough BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE 5 mg; 7.5 mg Lozenge?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cepacol Extra Strength Sore Throat and Cough 5 mg/1; 7.5 mgthis 63824-0744-16 Reckitt 16 lozenges $0.151 — FDA listed —
Walgreens Mixed Berry Benz-Dex Lozenges 7.5 mg/1; 5 mg 00363-1113-18 Walgreen 18 lozenges — — FDA listed —
Mixed Berry Sore Throat Lozenges 7.5 mg/1; 5 mg 36800-0836-18 Topco 18 lozenges — — FDA listed —
Mixed Berry Sore Throat and Cough Lozenges 7.5 mg/1; 5 mg 37808-0062-18 HEB 18 lozenges — — FDA listed —
Mixed Berry Sore Throat and Cough lozenge 7.5 mg/1; 5 mg 41250-0066-18 Meijer 18 lozenges — — FDA listed —
Mixed Berry Throat and Cough Lozenges 7.5 mg/1; 5 mg 69842-0377-18 CVS 18 lozenges — — FDA listed —
Equate Benz-Dex Cough and Throat Lozenges 7.5 mg/1; 5 mg 79903-0042-18 Walmart 18 lozenges — — 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

🏛️
2014
On the market since
May 2014
📍
2026
Currently FDA-listed
12 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 code63824
First marketedMay 2014
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 36 words ▾

Uses Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold pain associated with canker sores occasional irritation and pain due to a sore mouth or sore throat

⏱️ Dosage and Administration 105 words ▾

Directions adults and children 12 years of age and older take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist children under 6 years of age do not use

⚠️ Warnings ~1 min read ▾

Warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. 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. for teething in children under 6 years of age Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage.

📦 Storage and Handling 10 words ▾

Other information store at 20-25°C (68-77°F) protect contents from humidity

🧪 Active Ingredient 18 words ▾

Active ingredients (in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

🎯 Purpose 18 words ▾

Active ingredients (in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant

📄 Do Not Use 64 words ▾

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. for teething in children under 6 years of age

📄 Ask a Doctor Before Use If 28 words ▾

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 2 words ▾

Questions? 1-866-682-4639

📄 Package Label / Principal Display Panel 63 words ▾

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton NDC 63824-744-16 Cēpacol ® EXTRA STRENGTH #1 DOCTOR RECOMMENDED † SORE THROAT & COUGH Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant Relieves Sore Throat Pain Quiets Cough • Fast Acting Maximum Numbing* 16 Lozenges mixed berry flavor *based on amount of benzocaine per adult dose Label label 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 BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE — the ingredient across all brands.

Top reported reactions

Dyspnoea27
Death18
Nausea18
Dizziness17
Fatigue16
Sepsis14
Vomiting14

Age at onset

Adolescent1
Adult22
Elderly9

Reporter sex

243 reports
Male · 39%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization109
Death41
Life-threatening21
Disabling13
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 18 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
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 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 4 lozenges (63824-0744-94), 36 lozenges (63824-0744-36). 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.
← 63824-0732-16 · Reckitt 63824-0790-80 · 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.