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Cepacol Extra Strength Sore Throat honey lemon Benzocaine and Menthol 15 mg; 2.6 mg Lozenge, 16-count — NDC 63824-0732-16 package photo

Cepacol Extra Strength Sore Throat honey lemon Benzocaine and Menthol 15 mg; 2.6 mg Lozenge, 16-count

by Reckitt Benckiser LLC · 2 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK
NDC 63824-0732-16
🏷️ FDA NDC (as labeled) 63824-732-16 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) 63824-732-16
Product NDC 63824-732
11-digit billing NDC 63824073216
NCPDP billing unit EA — each (per item)
RxCUI 858664, 1235472
UNII U3RSY48JW5, L7T10EIP3A
UPC 0363824730165
Application # M022
SPL Set ID d771095b-7de3-48f3-a125-8bc76e7d1778
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 2013-07-15
Route ORAL
Dosage form LOZENGE
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
GPI-14 88359902154793
GPI class Cepacol Extra Strength
GCN Seq No 067736
GCN 30355
HICL code 001675
Ingredient (HICL) Benzocaine/Menthol
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0A
Therapeutic class — specific (HIC3) Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name CEPACOL THROAT 15-2.6 MG LOZ
FDB brand name Cepacol Sore Throat
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 63824-732-16 — 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 → 63824-0732-16. 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.

🏭 Manufacturer & labeler

LabelerReckitt Benckiser LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code63824
First marketedJul 2013
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 CEPACOL THROAT 15-2.6 MG LOZ Ingredient Benzocaine/Menthol
🧪 What is this product?

Cepacol Extra Strength Sore Throat is an over-the-counter lozenge containing benzocaine and menthol. Benzocaine is a local anesthetic typically used to numb sore throat pain, while menthol is commonly used for its cooling and soothing sensations. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and use guidelines for throat lozenges rather than being individually reviewed.

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.

💊 What it looks like

Color orange
ShapeRound
ImprintS
Size18 mm
ScoringNot scored
FlavorHoney
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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • 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 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • 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 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.

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

The official label also statesD&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

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 DailyMed — ingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.152 $2.43 / 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
Dec 2021 Apr 2022 Dec 2023 $0.152 $0.149
▲ 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
Cepacol Extra Strength Sore Throat honey lemon 15 mg/1; 2.6 mgthis 63824-0732-16 Reckitt 16 lozenges $0.152 — FDA listed —
Cepacol Extra Strength Sore Throat honey lemon 15 mg/1; 2.6 mg 17856-0732-01 ATLANTIC 50 lozenges — — FDA listed —
honey lemon sore throat lozenges 15 mg/1; 2.6 mg 59779-0644-18 CVS 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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.

🔬 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 Cepacol Extra Strength Sore Throat honey lemon (this brand).

Top reported reactions

Dyspnoea29
Nausea19
Death18
Dizziness17
Fatigue16
Vomiting15
Sepsis14

Age at onset

Adolescent1
Adult22
Elderly9

Reporter sex

248 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization109
Life-threatening21
Disabling13
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63824-0732-16 You're viewing this 2 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK 2013-07-15 Active

📄 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 17 words ▾

Uses Uses: temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores

⏱️ Dosage and Administration 44 words ▾

Directions adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use

⚠️ Warnings 211 words ▾

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 for teething in children under 5 years of age 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, rash, or fever develops 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 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

🎯 Purpose 18 words ▾

Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63824-0713-04 · Reckitt 63824-0744-16 · 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.