FDA.reportPublic FDA data

Cold Rub

Manufacturer
JMD All Star Impex Inc. | Steller Mercantile Pvt.Ltd.
Effective date
2010-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:50

Label at a glance#

ProductCold Rub
Active ingredientCAMPHOR (NATURAL), EUCALYPTUS OIL, MENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.8%

OTC - PURPOSE SECTION

PURPOSE

cough suppressant/topical analgesic
nasal decongestant/cough suppressant
cough suppressant/topical analgesic

INDICATIONS & USAGE SECTION

Uses

Temporarily relief for throat and chest

  • Cough 
  • Nasal congestion due to common cold
  • Aching muscles
  • Minor aches and pains

WARNINGS SECTION

Warning
For external use only. Avoid contact with eyes.

OTC - DO NOT USE SECTION

Do not use
  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with light bandages

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Asthma
  • Excessive phlegm (mucus)
  • Emphysema
  • Persistent or chronic cough
  • Cough associated with smoking

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 case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • See important warnings under "When using product"
  • Children under 2 years of age, ask a doctor before using the product
  • Adults and children 2 years of age and older: rub a thick layer chest and throat or sore aching muscles. If desired loosely cover with a soft cloth but keep clothing loose. Repeat up to 3 times daily

SPL UNCLASSIFIED SECTION

Other Information
  • Store at room temperature

INACTIVE INGREDIENT SECTION

Other Ingredients
Cedar leaf Oil, Mineral Oil, Nutmeg Oil, Petrolatum, Spirits of Turpentine, Thymol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

image of package labelimage of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048072camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.8 % Topical OintmentPSN1
1048072camphor 0.048 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.028 MG/MG Topical OintmentSCD1
1048072camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.8 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51444-001-382019-10-21C16284748780-1956f9ecf-ca41-621f-e053-dbdaa90a74ad7f07d3cb-6075-475a-a7ab-62216933f6b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51444-001-38Cold Rub108 g in 1 JAROINTMENT1081

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51444-001COLD RUB (CAMPHOR EUCALYPTUS OIL MENTHOL) OINTMENT [JMD ALL STAR IMPEX INC.]1Legacy NDC, 1 package rows20100615_7f07d3cb-6075-475a-a7ab-62216933f6b5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
EUCALYPTUS OILACTIVE INGREDIENT2R04ONI6621
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
EUCALYPTUS OILACTIVE MOIETY2R04ONI6621
MENTHOLACTIVE MOIETYL7T10EIP3A1
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLG1
NUTMEGINACTIVE INGREDIENTAEE24M3MQ91
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
THYMOLINACTIVE INGREDIENT3J50XA376E1
TURPENTINEINACTIVE INGREDIENTXJ6RUH0O4G1

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
51444-00151444-001-38

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
NUTMEGAEE24M3MQ9IACT
PETROLATUM4T6H12BN9UIACT
THYMOL3J50XA376EIACT
TURPENTINEXJ6RUH0O4GIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
THYMOLTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
THYMOLTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates

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
e9885138-6619-4675-83a7-eedadeeca8a87f07d3cb-6075-475a-a7ab-62216933f6b52010-05-30WarningsExact identifier
spl id: e9885138-6619-4675-83a7-eedadeeca8a8
spl set id: 7f07d3cb-6075-475a-a7ab-62216933f6b5

Reported adverse events (FAERS/openFDA)#

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