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CEPASTAT Sore throat and Cough Benzocaine, Dextromethorphan HBr, Menthol 10 mg; 6 mg; 5 mg Lozenge, 18-count — NDC 63736-205-01 (Billing 63736-0205-01)

by Insight Pharmaceuticals LLC · 3 BLISTER PACK in 1 CARTON / 6 LOZENGE in 1 BLISTER PACK

This is a package of 18 lozenges of CEPASTAT Sore throat and Cough Benzocaine, Dextromethorphan HBr, Menthol 10 mg; 6 mg; 5 mg Lozenge from Insight Pharmaceuticals LLC, no longer marketed (first marketed Oct 2016), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 63736-0205-01
🏷️ FDA NDC (as labeled) 63736-205-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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 63736-205-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63736 labeler · 205 product · 01 package
Package marketed since
Oct 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6373620501 0
FDA record last changed
Sep 3, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2019. 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63736-205-01
Product NDC 63736-205
11-digit billing NDC 63736020501
RxCUI 1045532, 1872897
UNII L7T10EIP3A, U3RSY48JW5, 9D2RTI9KYH
Application # M022
SPL Set ID 93f0e60f-4dda-4ec9-b391-e059a0876654
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 (certified through Aug 2019)
Marketing start 2016-10-01
Route ORAL
Dosage form LOZENGE
Substance MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1045532
Why two NDCs? The FDA registers this code as 63736-205-01 — 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 → 63736-0205-01. 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

🧪 What is this product?

Cepastat is an over-the-counter lozenge that dissolves in the mouth and contains three active ingredients commonly used for sore throat and cough relief. Benzocaine is a local anesthetic that temporarily numbs throat pain and irritation. Dextromethorphan is a cough suppressant typically used to reduce the urge to cough. Menthol provides a cooling sensation and is commonly included in throat lozenges for its soothing properties. This product is marketed under FDA's over-the-counter monograph rules for cough and cold lozenges.

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 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.
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 Marketing startMarketing endStatus
63736-0205-01 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 6 LOZENGE in 1 BLISTER PACK 2016-10-01 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diabetic Tussin Sore Throat and Cough Cherry 6 mg/1; 5 mg/1; 10 mg 61787-0070-15 MEDTECH 15 lozenges — — FDA listed —
CEPASTAT Sore throat and Cough 10 mg/1; 6 mg/1; 5 mgthis 63736-0205-01 Insight 18 lozenges — — Discontinued —
Chloraseptic Total Sore Throat and Cough, Sugar Free 10 mg/1; 6 mg/1; 5 mg 67172-0015-11 Prestige 15 lozenges — — FDA listed —
Chloraseptic Total Sore Throat and Cough 10 mg/1; 6 mg/1; 5 mg 67172-0016-11 Prestige 15 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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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

LabelerInsight Pharmaceuticals LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code63736
First marketedOct 2016
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from Insight Pharmaceuticals LLC labeler code 63736

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth cough due to minor throat and bronchial irritation as may occur with the common cold

⏱️ Dosage and Administration 51 words ▾

Directions Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours. Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours. Children under 6 years of age: consult a doctor.

⚠️ Warnings ~1 min read ▾

Warnings 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 : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly.

Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor. Do not use this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product do not exceed recommended dosage. Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 25 words ▾

Active Ingredients (in each lozenge) Benzocaine 6 mg

Active Ingredients (in each lozenge) Dextromethorphan HBr 5 mg

Active Ingredients (in each lozenge) Menthol 10 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerine, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water

🎯 Purpose 9 words ▾

Purpose Oral Anesthetic/Analgesic

Purpose Cough Suppressant

Purpose Oral Anesthetic/Analgesic

📄 Do Not Use 85 words ▾

Do not use this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

📄 Ask a Doctor Before Use If 59 words ▾

Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage.

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 24 words ▾

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

📄 Other Information 18 words ▾

Other information Store between 59ºF and 86ºF (15ºC - 30ºC). Protect from moisture. Check expiration date before using.

📄 Questions or Comments 2 words ▾

Questions? 1-800-552-7932

📄 Package Label / Principal Display Panel 60 words ▾

PRINCIPAL DISPLAY PANEL CĒPASTAT ® SORE THROAT & COUGH Menthol/Benzocaine | Oral Anesthetic/Analgesic Dextromethorphan HBr 5 mg | Cough Suppressant FAST ACTING SORE THROAT & COUGH RELIEF 18 LOZENGES CHERRY SUGAR FREE PRINCIPAL DISPLAY PANEL CĒPASTAT® SORE THROAT & COUGH Menthol/Benzocaine | Oral Anesthetic/Analgesic Dextromethorphan HBr 5 mg | Cough Suppressant FAST ACTING SORE THROAT & COUGH RELIEF 18 LOZENG

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

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 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.
Who lists this product with the FDA?
Insight Pharmaceuticals 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.
← 63736-0200-04 · Insight 63736-0238-24 · Insight →
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.