FDA.reportPublic FDA data

Cough and Cold Therapy

Manufacturer
Everlaan Organics Inc | Cosmaceutical Research Laboratory Inc
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:43

Label at a glance#

ProductCough and Cold Therapy
Active ingredientMENTHOL, EUCALYPTUS OIL, CAMPHOR (NATURAL)
Label structure8 sections

Indications and uses

Temporarily relieves cough associated with the common cold.

Dosage and administration

See important warnings under "When using this product" Adults: rub on the throat, chest and/or bottom of feet massage into skin until solution vanishes cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth use up to 3 times daily or as directed by a doctor

Storage and handling

Tamper-evident. Ensure seal is intact before use.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Organic Camphor 5.0%

Organic Menthol 2.8%

Organic Eucalyptus Oil 1.3%

Purpose

OTC - PURPOSE SECTION

Organic Camphor 5.0%.......................Topical Antitussive

Organic Menthol 2.8%.........................Topical Antitussive

Organic Eucalyptus Oil 1.3%...............Topical Antitussive

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves cough associated with the common cold.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • by mouth
  • in nostrils

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus).

OTC - WHEN USING SECTION

When using this product, do not

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • a cough that 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 breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

See important warnings under "When using this product"

Adults:

  • rub on the throat, chest and/or bottom of feet
  • massage into skin until solution vanishes
  • cover with a warm, dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to 3 times daily or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

Tamper-evident. Ensure seal is intact before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic Beeswax, Organic Coconut Oil, Organic Jojoba Oil, Organic Olive Oil, Organic Rosemary Oil, Organic Shea Butter, Vitamin E.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

maple organics

Cough & Cold Relief

Soothing & Calming Cough Relief Vapor Rub

Net Wt. 2oz / 56 g

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2668188camphor 5 % / eucalyptus oil 1.3 % / menthol 2.8 % Topical OintmentPSN3
2668188camphor 0.05 MG/MG / Eucalyptus oil 0.013 MG/MG / menthol 0.028 MG/MG Topical OintmentSCD3
2668188camphor 5 % / eucalyptus oil 1.3 % / menthol 2.8 % Topical OintmentSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83670-200-02Cough and Cold Therapy56 g in 1 JAROINTMENT563
83670-200-02Cough and Cold Therapy1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83670-200COUGH AND COLD THERAPY (CAMPHOR, MENTHOL, EUCALYPTUS OIL) OINTMENT [EVERLAAN ORGANICS INC]3Current NDC, 2 package rows20250129_088be461-7afc-586a-e063-6294a90a700b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83670-20083670-200-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROSEMARY OIL8LGU7VM393IACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
YELLOW WAX2ZA36H0S2VIACT
MENTHOLL7T10EIP3AACTIB
OLIVE OIL6UYK2W1W1EIACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
EUCALYPTUS OIL2R04ONI662ACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB

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
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
ndc (package): 83670-200-02
ndc (product): 83670-200
ndc11 (package): 83670020002
spl id: 2cb28ccc-a27a-3d5c-e063-6394a90aeefe
spl set id: 088be461-7afc-586a-e063-6294a90a700b

Reported adverse events (FAERS/openFDA)#

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