FDA.reportPublic FDA data

Assured VAPORIZING CHEST RUB

Manufacturer
Royal Exports
Effective date
2019-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:01

Label at a glance#

ProductAssured VAPORIZING CHEST RUB
Active ingredientCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOL
Label structure11 sections

Indications and uses

temporarily relieves nasal congestion, chest congestion, and cough due to the common cold temporarily relieves minor aches and pains

Dosage and administration

Adults and children 2 years of age and older rub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore aching muscles If desired, cover with a soft dry cloth but keep clothing loose repeat up to three times daily especially at bedtime Children under 2 years of age consult your physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4.7 % Eucalyptus Oil 1% Menthol 2%

Purpose

OTC - PURPOSE SECTION

Decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion, chest congestion, and cough due to the common cold
  • temporarily relieves minor aches and pains

Warnings:

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Do not put into mouth, nostrils or on wounds or damaged skin

Consult a doctor before use if

OTC - ASK DOCTOR SECTION

  • you are pregnant or breast feeding
  • you have ashtma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus
  • If mucus lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache

Do not use near

OTC - DO NOT USE SECTION

  • open flame
  • microwave oven
  • a container in which water is being heated except when adding cold water to a hot stream vaporizer

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If ingested, get medical help or contract a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older

  • rub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore aching muscles
  • If desired, cover with a soft dry cloth but keep clothing loose
  • repeat up to three times daily especially at bedtime

Children under 2 years of age

  • consult your physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046348camphor 4.7 % / eucalyptus oil 1 % / menthol 2 % Topical GelPSN1
1046348camphor 0.047 MG/MG / Eucalyptus oil 0.01 MG/MG / menthol 0.02 MG/MG Topical GelSCD1
1046348camphor 4.7 % / eucalyptus oil 1 % / menthol 2 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51328-2060-12021-01-29C16284748780-1ba0f9c33-3a8f-a910-e053-dadaa90a0b85Assured Chest Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51328-2060-1Assured VAPORIZING CHEST RUB113 g in 1 JARGEL1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51328-2060ASSURED VAPORIZING CHEST RUB (MENTHOL CAMPHOR EUCALYPTUS OIL) GEL [ROYAL EXPORTS]1Legacy NDC, 1 package rows20190330_85458320-2f1e-5517-e053-2991aa0a55c4.zip

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
51328-206051328-2060-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
NUTMEG OILZ1CLM48948IACT
TURPENTINE OILC5H0QJ6V7FIACT
THYMOL3J50XA376EIACT
CEDAR LEAF OILBJ169U4NLGIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
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
85458320-2f1f-5517-e053-2991aa0a55c485458320-2f1e-5517-e053-2991aa0a55c42019-03-29WarningsExact identifier
spl id: 85458320-2f1f-5517-e053-2991aa0a55c4
spl set id: 85458320-2f1e-5517-e053-2991aa0a55c4

Reported adverse events (FAERS/openFDA)#

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