FDA.reportPublic FDA data

Vicks VapoRub

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2021-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:52:53

Label at a glance#

ProductVicks VapoRub
Active ingredientCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOL
Label structure8 sections

Indications and uses

when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associatedwith the common cold

Dosage and administration

see important warnings under " When using this product " adults and children 2 years and over rub a thick layer on throat & chest & cover with a warm, dry cloth if desired keep clothing loose about throat and chest to help vapors reach the nose and mouth use up to three times daily or as directed by doctor children under 2 years: do not use

Storage and handling

store at less than 30ºC (86ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor (synthetic) 4.8%
Eucalyptus oil 1.2%
Menthol 2.6%

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Cough suppressant

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associatedwith the common cold

Warnings

WARNINGS SECTION

For external use only; avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

  • by mouth
  • in nostrils

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

When using this product, do not

OTC - WHEN USING SECTION

  • heat
  • microwave
  • add to hot water or any container where heating water.
    May cause splattering and result in burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

see important warnings under " When using this product"

  • adults and children 2 years and over
  • rub a thick layer on throat & chest &
  • cover with a warm, dry cloth if desired
  • keep clothing loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by doctor
  • children under 2 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at less than 30ºC (86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

PRINCIPAL DISPLAY PANEL - 100 g Jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

VapoCough ™

COUGH SUPPRESSANT

Ointment


NET WT
3.53 OZ (100 g)

547547

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-917-012021-02-12C16284748780-1ba0f9c33-41be-a910-e053-dadaa90a0b85Vicks ® VapoCough™
37000-917-012021-01-29C16284748780-1ba0f9c33-41be-a910-e053-dadaa90a0b85Vicks ® VapoCough™

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-91737000-917-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CEDAR LEAF OILBJ169U4NLGIACT
NUTMEG OILZ1CLM48948IACT
THYMOL3J50XA376EIACT
TURPENTINE OILC5H0QJ6V7FIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
MENTHOLL7T10EIP3AACTIB
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML · Source PDF

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
ef68df8f-3f27-0c9e-e053-2a95a90abe9c6ea06aaa-9950-36bf-e053-2991aa0ac1672022-12-09WarningsExact identifier
spl set id: 6ea06aaa-9950-36bf-e053-2991aa0ac167

Reported adverse events (FAERS/openFDA)#

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