FDA.reportPublic FDA data

Throat Coat

Manufacturer
Traditional Medicinals, Inc.
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:22

Label at a glance#

ProductThroat Coat Eucalyptus Mint
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure14 sections

Indications and uses

Temporarily relieves Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants. Occasional minor irritaions, pain, sore mouth, and sore throat.

Dosage and administration

Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day Children under 12 years of age : ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per drop) Organic menthol 6 mg

Purpose

OTC - PURPOSE SECTION

Purposes cough suppressant / oral anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves

  • Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants.
  • Occasional minor irritaions, pain, sore mouth, and sore throat.

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by physician.

Do not use

OTC - DO NOT USE SECTION

Do not use:

  • If you are allergic to any of the ingredients.
  • Produced in a facility that also processes almonds, coconuts, pecans, peanuts, soy, and milk products

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • A persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
  • Cough accopanied by excessive phlegm (mucus)

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent heacache. This could be the sign of a sereious condition.
  • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting.
  • Sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persistst or worsesns.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day
  • Children under 12 years of age: ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Each lozenge contains 5 mg of potassium.
  • Store in a cool, dry place.
  • Do not use if the outer wrap is opened or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic eucalyptus oil, organic glulcose syrup, organic ivy extract, pectin, organic peppermint oil, organic rapeseed oil, organic raw cane sugar, water.

Questions

OTC - QUESTIONS SECTION

call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F

SPL UNCLASSIFIED SECTION

TRADITIONAL MEDICINALS ®

ORGANIC Throat Coat ®

Soothes Sore Throats & Relieves Coughs

EUCALYPTUS MINT

Cough Suppressant

Oral Anesthetic

30 MENTHOL COUGH DROPS

Distributed by:

Traditional Medicinals

1400 Valley House Dr, Suite 120

Rohnert Park, CA 94928

traditionalmedicinals.com

Certified organic by CCOF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78732-002-00Throat CoatEucalyptus Mint4.2 g in 1 PACKAGELOZENGE4.24
78732-002-00Throat CoatEucalyptus Mint2 in 1 POUCHLOZENGE24
78732-002-01Throat CoatEucalyptus Mint4.2 g in 1 PACKAGELOZENGE4.24
78732-002-01Throat CoatEucalyptus Mint16 in 1 POUCHLOZENGE164
78732-002-30Throat CoatEucalyptus Mint30 in 1 POUCHLOZENGE304
78732-002-30Throat CoatEucalyptus Mint4.2 g in 1 PACKAGELOZENGE4.24

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
78732-00278732-002-01, 78732-002-30, 78732-002-00

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
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PEPPERMINT OILAV092KU4JHIACT
CANOLA OIL331KBJ17RKIACT
CORN SYRUP9G5L16BK6NIACT
PECTIN89NA02M4RXIACT
WATER059QF0KO0RIACT
RAW SUGAR8M707QY5GHIACT
EUCALYPTUS OIL2R04ONI662IACT
HEDERA HELIX LEAFZP9XFG71A7IACT

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
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
ndc (package): 78732-002-01
ndc (package): 78732-002-30
ndc (package): 78732-002-00
ndc (product): 78732-002
ndc11 (package): 78732000200
ndc11 (package): 78732000230
ndc11 (package): 78732000201
spl id: 44f829e8-9667-94ef-e063-6394a90aef35
spl set id: a7a86f1b-30e8-6f5d-e053-2a95a90a2a82

Reported adverse events (FAERS/openFDA)#

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