Home › NDC Lookup › Ingredients › Benzocaine And Menthol › 37000-0935-16
Vicks VapoCool Sore Throat Benzocaine and Menthol 15 mg; 20 mg Lozenge, 16-count — NDC 37000-0935-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vicks VapoCool Sore Throat Benzocaine and Menthol 15 mg; 20 mg Lozenge, 16-count — NDC 37000-935-16 (Billing 37000-0935-16)

by The Procter & Gamble Manufacturing Company · 2 BLISTER PACK in 1 CARTON / 8 LOZENGE in 1 BLISTER PACK

This is a package of 16 lozenges of Vicks VapoCool Sore Throat Benzocaine and Menthol 15 mg; 20 mg Lozenge from The Procter & Gamble Manufacturing Company, marketed since Oct 2019 and currently FDA-listed. It is this product's only package size.

NDC 37000-0935-16
🏷️ FDA NDC (as labeled) 37000-935-16 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 37000-935-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
37000 labeler · 935 product · 16 package
Package marketed since
Oct 9, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 3700093516 3
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 37000-935-16
Product NDC 37000-935
11-digit billing NDC 37000093516
Application # M022
SPL Set ID 911a05de-cb3f-c1d2-e053-2995a90ae4be
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Cell-mediated Immunity; Increased Histamine Release
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-09
Route ORAL
Dosage form LOZENGE
Substance BENZOCAINE; MENTHOL
Why two NDCs? The FDA registers this code as 37000-935-16 — 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 → 37000-0935-16. 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.

Clinical

🧪 What is this product?

This is an oral lozenge containing benzocaine and menthol, marketed as an over-the-counter monograph product under FDA rules for its category. Benzocaine is a topical numbing agent typically used to reduce pain sensations in the mouth and throat, while menthol is commonly included for its cooling sensation and is often used in sore throat products for mild comfort. The lozenge dissolves in the mouth to deliver these ingredients directly to the throat area.

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
37000-0935-16 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 8 LOZENGE in 1 BLISTER PACK 2019-10-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vicks VapoCool Sore Throat 15 mg/1; 20 mgthis 37000-0935-16 The 16 lozenges — — FDA listed —
Vicks VapoCool SEVERE plus Intense Pain Relief 15 mg/1; 20 mg 84126-0366-30 The 30 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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 yellow
ShapeRound
ImprintVicks;logo
Size19 mm
ScoringNot scored
FlavorMenthol
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 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 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.

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

The official label also statescorn syrup, flavors, propylene glycol, sucrose

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.

Manufacturer & labeler

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code37000
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio851 products on file

More NDCs from The Procter & Gamble Manufacturing Company labeler code 37000

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 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 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 14 words ▾

Uses temporarily relieves occasional minor irritation and pain due to sore throat sore mouth

⏱️ Dosage and Administration 34 words ▾

Directions adults and children 12 years and over: dissolve 1 lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 12 years: do not use.

⚠️ Warnings 78 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

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information store at room temperature; protect from moisture contains soy

🧪 Active Ingredient 15 words ▾

Active ingredients (per lozenge) Benzocaine 15 mg Menthol 20 mg Purpose Oral anesthetic Oral anesthetic

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients corn syrup, flavors, propylene glycol, sucrose

🎯 Purpose 5 words ▾

Purpose Oral anesthetic Oral anesthetic

📄 Do Not Use 9 words ▾

Do not use for teething in children under 2

📄 Ask a Doctor Before Use If 36 words ▾

Ask a doctor before use if you have a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 2 words ▾

Questions? 1-800-283-4879

📄 Package Label / Principal Display Panel 29 words ▾

PRINCIPAL DISPLAY PANEL - 16 Lozenges Carton VICKS ® VapoCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS COOLING + NUMBING Soothes Throat Pain Fast-acting WINTERFROST 16 LOZENGES 935

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
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 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.
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 The Procter & Gamble Manufacturing Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Procter & Gamble Manufacturing Company 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.
← 37000-0934-12 · The 37000-0938-02 · The →
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.