FDA.reportPublic FDA data

VICKS

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-07 01:02:55

Label at a glance#

ProductVicks VapoCool Sore Throat
Active ingredientBENZOCAINE, MENTHOL
Label structure19 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

store at room temperature; protect from moisture contains soy

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 15 mg
Menthol 20 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional minor irritation and pain due to

  • sore throat
  • sore mouth

Warnings

WARNINGS SECTION

Methemoglobinemia Warning–

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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 –

SPL UNCLASSIFIED SECTION

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 12 years of age.

Do not use

OTC - DO NOT USE SECTION

  • for teething
  • in children under 2

When using this product

SPL UNCLASSIFIED SECTION

do not exceed recommended dosage

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature; protect from moisture
  • contains soy

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, flavors, propylene glycol, sucrose

Questions?

OTC - QUESTIONS SECTION

1-800-283-4879

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 16 Lozenges Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

VapoCOOL

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

COOLING + NUMBING

Soothes Throat Pain
Fast-acting

WINTERFROST

16 LOZENGES

935935

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-935-162021-02-12C16284748780-1ba0f9c33-138f-a910-e053-dadaa90a0b85VICKS ® VapoCOOL™ Sore Throat Lozenges
37000-935-162021-02-12C16284748780-1ba0f9c33-138f-a910-e053-dadaa90a0b85VICKS ® VapoCOOL™ Sore Throat Lozenges
37000-935-162021-01-29C16284748780-1ba0f9c33-138f-a910-e053-dadaa90a0b85VICKS ® VapoCOOL™ Sore Throat Lozenges
37000-935-162021-01-29C16284748780-1ba0f9c33-138f-a910-e053-dadaa90a0b85VICKS ® VapoCOOL™ Sore Throat Lozenges

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-93537000-935-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB
SUCROSEC151H8M554IACT
CORN SYRUP9G5L16BK6NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-03-23full-release2026-06-01 01:51:13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks VapoCool Sore ThroatBENZOCAINE AND MENTHOLThe Procter & Gamble Manufacturing Company911a05de-cb3f-c1d2-e053-2995a90ae4be2026-03-23WarningsExact identifier
ndc (package): 37000-935-16
ndc (product): 37000-935
ndc11 (package): 37000093516
spl set id: 911a05de-cb3f-c1d2-e053-2995a90ae4be

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.