FDA.reportPublic FDA data

Vicks ® VapoCOOL™ HydraSoothe Medicated Drops

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:51:27

Label at a glance#

ProductVicks VapoCOOL HydraSoothe
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

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 12 years and under: do not use

Storage and handling

Store at 20°-25°C (68°-77°F) in a dry place Contains Soy.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol 15 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

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 5 years of age unless directed by doctor.

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. 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 12 years and under: do not use

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°-25°C (68°-77°F) in a dry place
  • Contains Soy.

Inactive ingredients

INACTIVE INGREDIENT SECTION

eucalyptol, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, gum arabic, potassium sorbate, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-707-1709

SPL UNCLASSIFIED SECTION

Distributed by
Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 50 Drop Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS®

VapoCOOL™

HYDRASOOTHE

MENTHOL ·ORAL ANESTHETIC

WINTERFROST

  • Powerful Rush of Vicks Vapors
  • Soothes Sore Throats
  • Hydrating Action*

ACTUAL SIZE

50 MEDICATED DROPS

936936

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-936-502021-02-12C16284748780-1ba0f9c33-1392-a910-e053-dadaa90a0b85Vicks ® VapoCOOL™ HydraSoothe Medicated Drops
37000-936-502021-01-29C16284748780-1ba0f9c33-1392-a910-e053-dadaa90a0b85Vicks ® VapoCOOL™ HydraSoothe Medicated Drops

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-93637000-936-50

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
SUCROSEC151H8M554IACT
ACACIA5C5403N26OIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CORN SYRUP9G5L16BK6NIACT
FD&C RED NO. 40WZB9127XOAIACT
EUCALYPTOLRV6J6604TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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
051d2804-b052-7e2c-e063-6394a90a22b3911afffc-4ec5-7de7-e053-2995a90aea3f2023-09-11WarningsExact identifier
spl set id: 911afffc-4ec5-7de7-e053-2995a90aea3f

Reported adverse events (FAERS/openFDA)#

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