FDA.reportPublic FDA data

Cough and Cold Therapy For Kids

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 For Kids
Active ingredientCAMPHOR (NATURAL), MENTHOL, EUCALYPTUS OIL
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" Children 2 years and older: rub on the throat and chest in a thick layer 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 Children under 2 years of age: Ask a doctor.

Storage and handling

Tamper-evdent. Ensure seal is intact before use.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Organic Camphor 4.7%

Organic Menthol 2.6%

Organic Eucalyptus Oil 1.2%

Purpose

OTC - PURPOSE SECTION

Organic Camphor 4.7%......................Topical Antitussive

Organic Menthol 2.6%........................Topical Antitussive

Organic Eucalyptus Oil 1.2%..............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 asthma 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 fevrer, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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"

Children 2 years and older:

  • rub on the throat and chest in a thick layer
  • 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

Children under 2 years of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Tamper-evdent. Ensure seal is intact before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

maple organics

Cough & Cold Therapy For Kids

Soothing & Calming Cough Suppressant

Net Wt. 2 oz / 56 g

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200293camphor 4.7 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentPSN3
200293camphor 0.047 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCD3
200293camphor 4.7 % / eucalyptus oil 1.2 % / menthol 2.6 % 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
83670-201-02Cough and Cold Therapy For Kids1 in 1 CARTONOINTMENT13
83670-201-02Cough and Cold Therapy For Kids56 g in 1 JAROINTMENT563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83670-201COUGH AND COLD THERAPY FOR KIDS (CAMPHOR, MENTHOL, EUCALYPTUS OIL) OINTMENT [EVERLAAN ORGANICS INC]3Current NDC, 2 package rows20250129_088df369-114c-db4f-e063-6394a90acfac.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
83670-20183670-201-02

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
CAMPHOR (NATURAL)N20HL7Q941ACTIB
YELLOW WAX2ZA36H0S2VIACT
JOJOBA OIL724GKU717MIACT
MENTHOLL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
OLIVE OIL6UYK2W1W1EIACT

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 Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact identifier
ndc (package): 83670-201-02
ndc (product): 83670-201
ndc11 (package): 83670020102
spl id: 2cb2d3da-78ac-4420-e063-6394a90a771a
spl set id: 088df369-114c-db4f-e063-6394a90acfac

Reported adverse events (FAERS/openFDA)#

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