FDA.reportPublic FDA data

Vicks VapoCOOL SEVERE

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-07 01:02:00

Label at a glance#

ProductVicks VapoCOOL SEVERE
Active ingredientMENTHOL
Label structure15 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

Menthol 20 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional minor irritation and pain due to

  • sore throat
  • sore mouth

Warnings

WARNINGS SECTION

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.

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.

SPL UNCLASSIFIED 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

beta carotene, corn syrup, flavors, honey, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-707-1709

SPL UNCLASSIFIED SECTION

DIST. BY:

PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 70 drops in a bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE PACK

VICKS ®

VapoCOOL™

SEVERE

MENTHOL ·ORAL ANESTHETIC

MAX STRENGTH • FAST RELIEF

SOOTHES SORE THROAT

HONEY LEMON CHILL

70 MEDICATED DROPS

797797

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900045699GTIN-13: 0323900045699
EAN-13: 0323900045699
GTIN-12: 323900045699
UPC-A: 323900045699
GTIN storage (14 digits): 00323900045699		797.jpg
Data codeData Matrix21325678797.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

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
69423-79769423-797-18, 69423-797-45, 69423-797-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
CORN SYRUP9G5L16BK6NIACT
SUCROSEC151H8M554IACT
BETA CAROTENE01YAE03M7JIACT
HONEYY9H1V576FHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-10-03full-release2026-06-01 01:15:42

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 SEVEREMENTHOLThe Procter & Gamble Manufacturing Company042b6ea0-baf3-52d2-e063-6394a90ac6fb2025-10-03WarningsExact identifier
ndc (package): 69423-797-45
ndc (package): 69423-797-18
ndc (package): 69423-797-70
ndc (product): 69423-797
ndc11 (package): 69423079770
ndc11 (package): 69423079745
ndc11 (package): 69423079718
spl set id: 042b6ea0-baf3-52d2-e063-6394a90ac6fb

Reported adverse events (FAERS/openFDA)#

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