FDA.reportPublic FDA data

VICKS ® VapoCOOL™ SEVERE + Intense Pain Relief Drops

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-07 01:02:27

Label at a glance#

ProductVicks VapoCool SEVERE plus Intense Pain Relief
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 drop 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 no greater than 25°C (77°F) contains soy

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (per drop)

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 drop 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 no greater than 25°C (77°F)
  • contains soy

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ascorbyl palmiltate, beta-carotene, corn syrup, FD&C Blue No. 1, flavor, maltodextrin, propylene glycol, sucrose, sunflower oil, vitamin E DL-alpha, water

Questions?

OTC - QUESTIONS SECTION

1-800-707-1709

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 30 MEDICATED DROPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

VapoCOOL

SEVERE

MENTHOL & BENZOCAINE - ORAL ANESTHETICS

+INTENSE PAIN RELIEF

SOOTHES & NUMBS

SORE THROATS

ICY MINT

30 MEDICATED DROPS

366366

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900040144GTIN-13: 0323900040144
EAN-13: 0323900040144
GTIN-12: 323900040144
UPC-A: 323900040144
GTIN storage (14 digits): 00323900040144		366.jpg
Data codeData Matrix21311927366.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-36684126-366-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB
SUCROSEC151H8M554IACT
CORN SYRUP9G5L16BK6NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ASCORBYL PALMITATEQN83US2B0NIACT
BETA CAROTENE01YAE03M7JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MALTODEXTRIN7CVR7L4A2DIACT
SUNFLOWER OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
WATER059QF0KO0RIACT
ACACIA5C5403N26OIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-30full-release2026-06-01 01:07:12

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 SEVERE plus Intense Pain ReliefBENZOCAINE AND MENTHOLThe Procter & Gamble Manufacturing Company38cd83db-47ca-e320-e063-6394a90aba412025-06-30WarningsExact identifier
ndc (package): 84126-366-30
ndc (product): 84126-366
ndc11 (package): 84126036630
spl set id: 38cd83db-47ca-e320-e063-6394a90aba41

Reported adverse events (FAERS/openFDA)#

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