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Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge, 16-count — NDC 63824-0713-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge, 16-count — NDC 63824-713-16 (Billing 63824-0713-16)

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 cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge from Reckitt Benckiser LLC, marketed since Jul 2013 and currently FDA-listed; retail pharmacies pay about $0.1484 per lozenge (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 63824-0713-16
🏷️ FDA NDC (as labeled) 63824-713-16 billing pads the product segment with a zero
This package
Contains16-count Cost per ea$0.1484 NADAC Per package$2.37 / 16 lozenges Pack sizes3 compare ↓
Main listing for product 63824-713 · Also comes in: 4 lozenges 63824-713-04 4 lozenges 63824-713-94
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 63824-713-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63824 labeler · 713 product · 16 package
Package marketed since
Jul 15, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
16 EA per package
Barcode (UPC)
0363824710167
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63824-713-16
Product NDC 63824-713
11-digit billing NDC 63824071316
NCPDP billing unit EA — each (per item)
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 On market
FDA listing status Listed (active directory)
Marketing start 2013-07-15
Route ORAL
Dosage form LOZENGE
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM

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

GPI-14 88359902154795
GPI class Cepacol Sore Throat Ex St
GCN Seq No 067735
GCN 30354
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 15-3.6 MG LOZ
FDB brand name Cepacol Sore Throat
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 067735
  • GCN: 30354
  • GPI-14 (Medi-Span): 88359902154795
  • HICL (First Databank): 001675
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 824574
Why two NDCs? The FDA registers this code as 63824-713-16 — 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 → 63824-0713-16. 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 THROAT 15-3.6 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 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.

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 $0.148 $2.37 / 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 $0.148 $0.148
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
63824-0713-04 63824-713-04 1 BLISTER PACK in 1 CARTON / 4 LOZENGE in 1 BLISTER PACK — — 2013-07-15 — Discontinued by firm
63824-0713-16 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 8 LOZENGE in 1 BLISTER PACK $0.1484 / ea $2.37 2013-07-15 — Active
63824-0713-94 63824-713-94 1 BLISTER PACK in 1 CARTON / 4 LOZENGE in 1 BLISTER PACK — — 2013-07-15 — 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 63824-0713-04?
Both are Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol 15 mg; 3.6 mg Lozenge — the drug itself is identical. This page's package is the 16-count one, while NDC 63824-0713-04 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?
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
Sore Throat Logenzes Sore Throat 15 mg/1; 3.6 mg 00904-6255-49 Major 324 lozenges $0.145 — Availability likely save 2%
Cepacol Extra Strength Sore Throat cherry 15 mg/1; 3.6 mgthis 63824-0713-16 Reckitt 16 lozenges $0.148 — FDA listed —
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 —
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.

What it looks like

Color red
ShapeRound
ImprintS
Size18 mm
ScoringNot scored
FlavorCherry
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.

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 applicationM022 (OTC MONOGRAPH DRUG)
Labeler code63824
First marketedJul 2013
Product typeHuman Otc Drug
Portfolio174 products on file

More NDCs from Reckitt Benckiser LLC labeler code 63824

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 📄 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 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

📄 Do Not Use 12 words ▾

Do not use for teething in children under 5 years of age

📄 Stop Use and Ask a Doctor If 30 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, rash, or fever develops

🤰 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 54 words ▾

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton NDC 63824-713-16 Cēpacol ® EXTRA STRENGTH #1 DOCTOR RECOMMENDED † SORE THROAT Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers Relieves Sore Throat Pain Fast Acting Maximum Numbing* 16 Lozenges cherry flavor *based on amount of benzocaine per dose Label label 2

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.