Home › NDC Lookup › Ingredients › Menthol And Benzocaine And Dextromethorp... › 67172-0016-11
Chloraseptic Total Sore Throat and Cough Menthol and Benzocaine and Dextromethorphan Hydrobromide 10 mg; 6 mg; 5 mg Lozenge, 15-count — NDC 67172-0016-11 package photo

Chloraseptic Total Sore Throat and Cough Menthol and Benzocaine and Dextromethorphan Hydrobromide 10 mg; 6 mg; 5 mg Lozenge, 15-count

by Prestige Brands Holdings, Inc. · 1 BLISTER PACK in 1 CARTON (67172-016-11) / 15 LOZENGE in 1 BLISTER PACK
NDC 67172-0016-11
🏷️ FDA NDC (as labeled) 67172-016-11 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 67172-016-11
Product NDC 67172-016
11-digit billing NDC 67172001611
RxCUI 1045532, 1045541
UNII L7T10EIP3A, U3RSY48JW5, 9D2RTI9KYH
Application # M022
SPL Set ID 6b1a50d0-be54-4fcb-b5e2-b47abf3555c0
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 2010-08-01
Route ORAL
Dosage form LOZENGE
Substance MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
GCN Seq No 073356
GCN 37749
HICL code 041696
Ingredient (HICL) Dextrometh/Benzocaine/Menthol
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 48:08.00.00
AHFS class Antitussives
FDB label name CHLORASEPTIC TOTAL LOZENGE
FDB brand name Chloraseptic Total
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 67172-016-11 — 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 → 67172-0016-11. 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

LabelerPrestige Brands Holdings, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code67172
First marketedAug 2010
Product typeHuman Otc Drug
Portfolio42 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 CHLORASEPTIC TOTAL LOZENGE Ingredient Dextrometh/Benzocaine/Menthol
🧪 What is this product?

Chloraseptic Total Sore Throat and Cough is an over-the-counter lozenge containing three active ingredients. Benzocaine is a local anesthetic typically used to numb pain in the mouth and throat. Menthol is commonly used for its cooling sensation and may help soothe throat discomfort. Dextromethorphan hydrobromide is a cough suppressant typically used to reduce cough. This product is marketed under the FDA's over-the-counter monograph rules for oral 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.

💊 What it looks like

Color red
ShapeOval
ImprintC
Size4 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.

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

  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also statesCorn Syrup, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerin, Soy Lecithin, Sucrose, Water

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.
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
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 mg 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 mgthis 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

🏛️
2010
On the market since
Aug 2010
📍
2026
Currently FDA-listed
16 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
67172-0016-11 You're viewing this 1 BLISTER PACK in 1 CARTON (67172-016-11) / 15 LOZENGE in 1 BLISTER PACK 2010-08-01 Active

🧭 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 ✓ Available
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.
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 67172-016-11, 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: 67172-0016-11, written without dashes as 67172001611. 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 67172-0016-11, the first segment (67172) is the labeler code FDA assigned to Prestige Brands Holdings, Inc.; the middle segment (0016) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Prestige Brands Holdings, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Prestige Brands Holdings, Inc. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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: do not use

⚠️ Warnings ~2 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.

If a skin reaction occurs, stop use and seek medical help right away. 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 for teething in children under 6 years of age Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough is accompanied by excessive phlegm (mucus) 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, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 28 words ▾

Active i ngredients (in each lozenge) Benzocaine 6 mg

Active i ngredients (in each lozenge) Dextromethorphan HBr 5 mg

Active i ngredients (in each lozenge) Menthol 10 mg

🧪 Inactive Ingredients 19 words ▾

Inactive i ngredients Corn Syrup, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerin, Soy Lecithin, Sucrose, Water

🎯 Purpose 11 words ▾

Purpose Oral pain reliever

Purpose Cough Suppressant

Purpose Oral pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67172-0015-11 · Prestige 67172-0017-02 · Prestige →
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.