FDA.reportPublic FDA data

VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-10-10 01:02:08

Label at a glance#

ProductVicks VapoCool Sore Throat
Active ingredientBENZOCAINE, MENTHOL
Label structure20 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: Apply to the affected area (one spray). Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a doctor. children under 12 years, do not use.

Storage and handling

do not exceed 25ºC. Do not refrigerate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine (5 %)
Menthol (1 %)

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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: Apply to the affected area (one spray). Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a doctor.
  • children under 12 years, do not use.

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25ºC. Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sucralose

Questions?

OTC - QUESTIONS SECTION

1-800-283-4879

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

SPL UNCLASSIFIED SECTION

Made in Canada
Distributed by
Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

VapoCOOL

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

+ INTENSE PAIN RELIEF

COOLS & NUMBS

WINTERFROST

6 FL OZ (177 ml)

928928

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900040632GTIN-13: 0323900040632
EAN-13: 0323900040632
GTIN-12: 323900040632
UPC-A: 323900040632
GTIN storage (14 digits): 00323900040632		928.jpg
QR code linkQR Codescan.pg.com/01/00323900040632928.jpg
Data codeData Matrix21500919928.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-928-062021-02-12C16284748780-1ba0f9c33-453c-a910-e053-dadaa90a0b85VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
37000-928-062021-02-12C16284748780-1ba0f9c33-453c-a910-e053-dadaa90a0b85VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
37000-928-062021-02-12C16284748780-1ba0f9c33-453c-a910-e053-dadaa90a0b85VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
37000-928-062021-01-29C16284748780-1ba0f9c33-453c-a910-e053-dadaa90a0b85VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
37000-928-062021-01-29C16284748780-1ba0f9c33-453c-a910-e053-dadaa90a0b85VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
37000-928-062021-01-29C16284748780-1ba0f9c33-453c-a910-e053-dadaa90a0b85VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-928-06ML - Milliliter37000-9286b019a87-e4e9-43b9-9514-f231ee27c72312021-03-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-92837000-928-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-10-06full-release2026-06-01 01:38:00
92025-06-24full-release2026-06-01 01:03:50

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 Company8749824b-6d04-430d-e053-2995a90a2db82025-10-06WarningsExact identifier
ndc (package): 37000-928-06
ndc (product): 37000-928
ndc11 (package): 37000092806
spl set id: 8749824b-6d04-430d-e053-2995a90a2db8

Reported adverse events (FAERS/openFDA)#

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