FDA.reportPublic FDA data

Throat Coat

Manufacturer
Traditional Medicinals, Inc.
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:11

Label at a glance#

ProductThroat Coat Sweet Orange Fennel
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per drop) Organic menthol 5 mg

OTC - PURPOSE SECTION

Purposes cough suppressant / oral anesthetic

INDICATIONS & USAGE SECTION

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.

WARNINGS SECTION

Warnings

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.

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.

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)

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 worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

SPL UNCLASSIFIED SECTION

  • Each lozenge contains 15 mg of potassium.
  • Store in a cool, dry place.
  • Do not use if the outer wrap is opened or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Organic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic cane sugar, water.

OTC - QUESTIONS SECTION

Questions?

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

SWEET ORANGE

Cough Suppressant

Oral Anesthetic

16 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311508menthol 5 MG Oral LozengePSN1
311508menthol 5 MG Oral LozengeSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78732-010-01Throat CoatSweet Orange Fennel16 in 1 POUCHLOZENGE161
78732-010-01Throat CoatSweet Orange Fennel4.2 g in 1 PACKAGELOZENGE4.21
78732-010-30Throat CoatSweet Orange Fennel30 in 1 POUCHLOZENGE301
78732-010-30Throat CoatSweet Orange Fennel4.2 g in 1 PACKAGELOZENGE4.21

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
78732-01078732-010-01, 78732-010-30

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
WATER059QF0KO0RIACT
LICORICE61ZBX54883IACT
PECTIN89NA02M4RXIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
FENNEL OIL59AAO5F6HTIACT
CANOLA OIL331KBJ17RKIACT
RAW SUGAR8M707QY5GHIACT
ORANGE OILAKN3KSD11BIACT
CORN SYRUP9G5L16BK6NIACT

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 Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
ndc (package): 78732-010-01
ndc (package): 78732-010-30
ndc (product): 78732-010
ndc11 (package): 78732001030
ndc11 (package): 78732001001
spl id: 45380791-66da-1518-e063-6394a90ac82c
spl set id: 4538248f-11cc-d6b2-e063-6294a90a652c

Reported adverse events (FAERS/openFDA)#

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