FDA.reportPublic FDA data

DELSYM

Manufacturer
RB Health (US) LLC
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:39:25

Label at a glance#

ProductDELSYM NO MESS VAPOR ROLL ON
Active ingredientCAMPHOR (NATURAL), EUCALYPTUS OIL, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold cough to help you sleep minor aches and pains of muscles and joints

Dosage and administration

see important warnings under " When using this product " adults and children 2 years of age and older for cough, apply a thick layer on the throat and chest cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth for muscle aches and pains, apply to affected area use up to three times daily or as directed by a doctor children under 2 years: as...

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Camphor 5.3%Cough suppressant/topical analgesic
Eucalyptus oil 1.3%Cough suppressant
Menthol 2.8%Cough suppressant/topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold
  • cough to help you sleep
  • minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
  • do not take by mouth or place in nostrils
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
  • muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days

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 of age and older
  • for cough, apply a thick layer on the throat and chest
  • cover with a warm, dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • for muscle aches and pains, apply to affected area
  • use up to three times daily or as directed by a doctor
  • children under 2 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

fragrance, glyceryl dibehenate, light mineral oil, octyldodecyl olivate, petrolatum

Questions?

OTC - QUESTIONS SECTION

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 50 g Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
NDC 72854-352-01

Delsym ®

NO MESS
VAPOR
ROLL-ON
Cough Suppressant & Topical Analgesic
COUGH RELIEF

100%
Natural
Camphor, Eucalyptus Oil,
Menthol

Ointment

Ages 2+

NET WT 1.76 OZ (50 g)

Principal Display Panel - 50 g Container Carton
Principal Display Panel - 50 g Container Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824819945GTIN-13: 0363824819945
EAN-13: 0363824819945
GTIN-12: 363824819945
UPC-A: 363824819945
GTIN storage (14 digits): 00363824819945		delsym-01.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-352-01GM - Gram72854-352b77088f1-4980-4285-a94c-cbc46208c46b12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-35272854-352-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL DIBEHENATER8WTH25YS2IACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-12-23full-release2026-06-01 00:48:31

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
42dc3573-2d85-88aa-e063-6394a90a1e80b168516f-1d7e-4fbd-ab66-9525fdf0d0862025-11-05WarningsExact identifier
spl id: 42dc3573-2d85-88aa-e063-6394a90a1e80
spl set id: b168516f-1d7e-4fbd-ab66-9525fdf0d086

Reported adverse events (FAERS/openFDA)#

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