FDA.reportPublic FDA data

STRONG VAPORIZING

Manufacturer
AFN BROKER LLC.
Effective date
2019-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:58:09

Label at a glance#

ProductSTRONG VAPORIZING
Active ingredientEUCALYPTUS OIL, MENTHOL, CAMPHOR (SYNTHETIC)
Label structure1 sections

Label contents#

Full prescribing information#

DRUG FACTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactDrug Fact

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

CAMPHOR 5.25%..............................COUGH SUPPRESSANT & TOPICAL ANALGESIC

EUCALYPTUS OIL 1.6%................................COUGH SUPPRESSANT

MENTHOL, NATURAL 3.15%..............................COUGH SUPPRESSANT & TOPICAL ANALGESIC Active IngredientsActive Ingredients

DO NOT USE

OTC - DO NOT USE SECTION

DO NOT USEDO NOT USE*BY MOUTH

*WITH TIGHT BANDAGES

*IN NOSTRILS

*ON WOUNDS OR DAMAGED SKIN

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

ASK A DOCTORASK A DOCTOR*COUGH THAT OCCURS WITH TOO MUCH PHLEGM (MUCUS)* PERSISTENT OR CHRONIC COUGH SUCH AS OCCURS WITH SMOKING, ASTHMA, EMPHYSEMA

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDRENIN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

WARNINGS

WARNINGS SECTION

WARNINGSWARNINGSFOR EXTERNAL USE ONLY; AVOID CONTACT WITH EYES

IF PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

PREGNANTPREGNANTASK A HEALTH PROFESSIONAL BEFORE USE

USE

USE IN SPECIFIC POPULATIONS SECTION

USESUSES*ON CHEST & THROAT, TEMPORARILY RELIEVES COUGH DUE TO COMMON COLD

*ON MUSCLES & JOINTS, TEMPORARILY RELIEVES MINOR ACHES AND PAIN

WHEN USING THIS PRODUCT, DO NOT

OTC - WHEN USING SECTION

WHEN USINGWHEN USING*HEAT OR MICROWAVE

*ADD TO HOT WATER OR ANY CONTAINER WHERE HEATING WATER

MAY CAUSE SPLATTERING AND RESULTS IN BURNS

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IFSTOP USE AND ASK A DOCTOR IF*MUSCLE ACHES AND PAINS PERSIST MORE THAN 7 DAYS OR COME BACK

*COUGH LASTS MORE THAN 7 DAYS, COME BACK, OR OCCURS IWTH FEVER RASH OR PERSISTENT HEADACHE.

THESE COULD BE SIGNS OF A SERIOUS CONDITION

STORAGE

STORAGE AND HANDLING SECTION

STORAGESTORAGESTORE AT ROOM TEMPERATURE

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

DIRECTIONSDIRECTIONSSEE IMPORTANT WARMING UNDER "WHEN USING THIS PRODUCT"

*ADULTS AND CHILDREN 2 YEARS AND OVER

*RUB A THICK LAYER ON CHEST & THROAT OR RUB ON SORE ACHING MUSCLES

*COVER WITH A WARM DRY CLOTH IF DESIRED

*KEEP CLOTHING LOOSE ABOUT THROAT/CHEST TO HELP VAPORS REACH NOSE/MOUTH

*REPEAT UP TO THREE TIMES PER 24 HOUSES OR AS DIRECTED BY A DOCTOR

*CHILDREN UNDER 2 YEARS OF AGE: ASK A DOCTOR

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTSINACTIVE INGREDIENTSNUTMEG OIL, TURPENTINE OIL, THYMOL, PARRAFIN WAX, MICROCRYSTALLINE WAX

PURPOSE

OTC - PURPOSE SECTION

COUGH SUPPRESSANT & TOPICAL ANALGESIC PURPOSEPURPOSE

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

INDICATIONS & USAGE SECTION

USEUSE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099014camphor 5.25 % / eucalyptus oil 1.6 % / menthol 3.15 % Topical OintmentPSN4
1099014camphor 0.0525 MG/MG / Eucalyptus oil 0.016 MG/MG / menthol 0.0315 MG/MG Topical OintmentSCD4
1099014camphor 5.25 % / eucalyptus oil 1.6 % / menthol 3.15 % Topical OintmentSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72004-001-042020-09-27C16284748780-1ab0e2407-2a9d-f274-e053-dbdaa90a647167791380-e5d0-cbbf-e053-2a91aa0a6f69
72004-001-042020-09-25C16284748780-1ab0e2407-2a9d-f274-e053-dbdaa90a647167791380-e5d0-cbbf-e053-2a91aa0a6f69
72004-001-042020-07-22C16284748780-1ab0e2407-2a9d-f274-e053-dbdaa90a647167791380-e5d0-cbbf-e053-2a91aa0a6f69

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72004-001-04STRONG VAPORIZING113 g in 1 JAROINTMENT1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72004-001STRONG VAPORIZING (CHEST RUB, COLD RUB, NASAL DECONGESTANT, COUGH SUPPRESSANT,) OINTMENT [AFN BROKER LLC.]4Legacy NDC, 1 package rows20190111_67791380-e5d0-cbbf-e053-2a91aa0a6f69.zip

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
72004-00172004-001-04

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
EUCALYPTUS OIL2R04ONI662ACTIB
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
NUTMEG OILZ1CLM48948IACT
TURPENTINE OILC5H0QJ6V7FIACT
THYMOL3J50XA376EIACT
PARAFFINI9O0E3H2ZEIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
7f1e9bdf-cd90-272f-e053-2a91aa0aabf467791380-e5d0-cbbf-e053-2a91aa0a6f692019-01-10WarningsExact identifier
spl id: 7f1e9bdf-cd90-272f-e053-2a91aa0aabf4
spl set id: 67791380-e5d0-cbbf-e053-2a91aa0a6f69

Reported adverse events (FAERS/openFDA)#

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