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Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge, 4-count

by Reckitt Benckiser LLC · 1 BLISTER PACK in 1 CARTON (63824-713-04) / 4 LOZENGE in 1 BLISTER PACK
NDC 63824-0713-04
🏷️ FDA NDC (as labeled) 63824-713-04 billing pads the product segment with a zero
This package
Contains4-count Pack sizes3 compare ↓
Also comes in: 4 lozenges 63824-0713-94 16 lozenges 63824-0713-16
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 63824-713-04
Product NDC 63824-713
11-digit billing NDC 63824071304
RxCUI 824574, 1235477
UNII U3RSY48JW5, L7T10EIP3A
UPC 0363824710167
Application # M022
SPL Set ID 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0
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 Discontinued
FDA listing status Discontinued by firm
Marketing start 2013-07-15
Route ORAL
Dosage form LOZENGE
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
GPI-14 88359902154795
GPI class Cepacol Sore Throat Ex St
Why two NDCs? The FDA registers this code as 63824-713-04 — 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 → 63824-0713-04. 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

🧪 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 minor pain and irritation in the mouth and throat. Menthol is commonly included in lozenges for its cooling sensation and mild analgesic properties. This product is marketed under FDA's OTC monograph rules for throat lozenges rather than as an individually approved drug application.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • 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 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 red no. 33, FD&C red no. 40, 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 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.
Try another pack size: 4 lozenges 16 lozenges
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
Sore Throat Logenzes Sore Throat 15 mg/1; 3.6 mg 00904-6255-49 Major 324 lozenges $0.146 — Availability likely —
Cherry Sore Throat Lozenge 15 mg/1; 3.6 mg 00363-1079-18 Walgreens 18 lozenges — — FDA listed —
Sore Throat Logenzes Sore Throat 15 mg/1; 3.6 mg 17856-6255-01 ATLANTIC 50 lozenges — — FDA listed —
cherry throat relief lozenges 15 mg/1; 3.6 mg 35418-0010-18 Zee 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenge 3.6 mg/1; 15 mg 36800-0832-18 TopCo 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenges 15 mg/1; 3.6 mg 41250-0068-18 Meijer 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenge 3.6 mg/1; 15 mg 41520-0043-18 American 18 lozenges — — FDA listed —
cherry throat relief lozenges 3.6 mg/1; 15 mg 42961-0401-18 Cintas 18 lozenges — — FDA listed —
Good Sense Cherry Benzocaine Lozenges 15 mg/1; 3.6 mg 50804-0025-18 Geiss, 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenges 15 mg/1; 3.6 mg 52642-0036-18 Bestco 18 lozenges — — FDA listed —
cherry sore throat lozenge 3.6 mg/1; 15 mg 59779-0545-18 CVS 18 lozenges — — FDA listed —
Cepacol Extra Strength Sore Throat cherry 15 mg/1; 3.6 mgthis 63824-0713-04 Reckitt 4 lozenges — — Discontinued —
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 cherry (this brand).

Top reported reactions

Dyspnoea28
Death18
Nausea18
Dizziness16
Fatigue16
Sepsis14
Vomiting14

Age at onset

Adolescent1
Adult23
Elderly9

Reporter sex

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

Serious outcomes

Hospitalization111
Death41
Life-threatening21
Reports over time (by year) — tap or hover for the count & year
2021 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
63824-0713-04 You're viewing this 1 BLISTER PACK in 1 CARTON (63824-713-04) / 4 LOZENGE in 1 BLISTER PACK — — 2013-07-15 Discontinued by firm
63824-0713-16 2 BLISTER PACK in 1 CARTON (63824-713-16) / 8 LOZENGE in 1 BLISTER PACK $0.1484 / ea $2.37 2013-07-15 Active
63824-0713-94 1 BLISTER PACK in 1 CARTON (63824-713-94) / 4 LOZENGE in 1 BLISTER PACK — — 2013-07-15 Discontinued by firm

Pack size FAQ

What quantity is in NDC 63824-0713-04?
NDC 63824-0713-04 is a 4-count package — 1 blister pack in 1 carton / 4 lozenge in 1 blister pack.
What is the difference between NDC 63824-0713-04 and NDC 63824-0713-94?
Both are Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge — the drug itself is identical. NDC 63824-0713-04 is the 4-count package, while NDC 63824-0713-94 is the 4 lozenges package.
What NDC number is used to bill for this package of Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge?
Bill NDC 63824-0713-04 — the 11-digit billing format is 63824071304. 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.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 63824-713-04, 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: 63824-0713-04, written without dashes as 63824071304. 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 63824-0713-04, the first segment (63824) is the labeler code FDA assigned to Reckitt Benckiser LLC; the middle segment (0713) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 4 lozenges (63824-0713-94), 16 lozenges (63824-0713-16). 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 ⏱️ 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 3.6 mg Oral pain reliever

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients D&C red no. 33, 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 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63824-0693-08 · Reckitt 63824-0732-16 · 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.