Throat Coat

Manufacturer: Phytoneering Extract Solutions GmbH
Effective date: 2010-06-30
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-05-31 22:25:31

Label at a glance#

ProductThroat Coat

Active ingredientMenthol

Label structure7 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Warnings
Sore throat warning: If sore throat is severe, accompanied or followed
by fever, headache, rash, swelling, nausea, or vomiting, consult a
doctor promptly. If sore mouth symptoms do not improve in 7 days, or if
irritation, pain, or redness persists or worsens, see your dentist or
doctor promptly. Do not exceed recommended dosage.

If pregnant or breastfeeding, ask a health professional before use.
Keep this and all drugs out of the reach of children.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each pastille) Purpose
Menthol 2.5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Oral pain reliever

OTC - PURPOSE SECTION

Uses: temporarily relieves occasional minor irritation, pain, sore mouth, sore throat

DOSAGE & ADMINISTRATION SECTION

Directions For adults and children 2 to 12 years of age: Allow 1 pastille to dissolve slowly in the mouth. May be repeated
every 2 hours as needed or as directed by a dentist or doctor. Children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Organic gum arabic, organic raw cane sugar, Throat Coat® herbal extract
(extractive obtained from a mixture of: licorice root, organic wild cherry bark,
organic bitter fennel fruit, organic cinnamon bark, organic sweet orange peel,
organic slippery elm bark, organic marshmallow root, and licorice root dry
extract), organic maltose syrup, honey, organic peppermint leaf essential oil,
organic sweet orange peel essential oil, organic fennel fruit essential oil,
organic cinnamon bark essential oil, natural vegetable and beeswax glaze.

OTC - DO NOT USE SECTION

Other Information
Tamper-evident: Each pastille is individually enclosed in a sealed, imprinted blister. Do not use if the blister unit is open or torn.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here

Principal Display Panel image

Carton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
616344	menthol 2.5 MG Oral Lozenge	PSN	13
616344	menthol 2.5 MG Oral Lozenge	SCD	13

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13340-5624-4	2019-10-21	C162847	48780-1	956f9ecf-bde7-621f-e053-dbdaa90a74ad	4a6c9e2d-58a3-4831-876c-644af778bdf6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13340-5624-4	Throat Coat	24 in 1 BLISTER PACK	PASTILLE	24		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13340-5624	THROAT COAT (MENTHOL) PASTILLE [PHYTONEERING EXTRACT SOLUTIONS GMBH]	13	Legacy NDC, 1 package rows	20100812_4a6c9e2d-58a3-4831-876c-644af778bdf6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	13
Menthol	ACTIVE MOIETY	L7T10EIP3A	13
Acacia	INACTIVE INGREDIENT	5C5403N26O	13
Cinnamon Bark Oil	INACTIVE INGREDIENT	XE54U569EC	13
Fennel Oil	INACTIVE INGREDIENT	59AAO5F6HT	13
Honey	INACTIVE INGREDIENT	Y9H1V576FH	13
Maltose Syrup	INACTIVE INGREDIENT	00JKR0NZ8O	13
Orange Oil	INACTIVE INGREDIENT	AKN3KSD11B	13
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	13
Raw Sugar	INACTIVE INGREDIENT	8M707QY5GH	13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Throat Coat
Menthol
Acacia
Raw Sugar
Maltose Syrup
Honey
Fennel Oil
Cinnamon Bark Oil
Orange Oil
Peppermint Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13340-5624	13340-5624-4

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
Name	UNII	Kind
Acacia	5C5403N26O	IACT
Raw Sugar	8M707QY5GH	IACT
Maltose Syrup	00JKR0NZ8O	IACT
Honey	Y9H1V576FH	IACT
Fennel Oil	59AAO5F6HT	IACT
Cinnamon Bark Oil	XE54U569EC	IACT
Orange Oil	AKN3KSD11B	IACT
Peppermint Oil	AV092KU4JH	IACT
Menthol	L7T10EIP3A	ACTIB

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 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	LIQUID / ORAL	50 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	SUSPENSION / INTRAMUSCULAR	1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	TABLET / SUBLINGUAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	POWDER, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	SYRUP / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	POWDER / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET / BUCCAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET / ORAL	70 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SPRAY, METERED / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	GUM, CHEWING / BUCCAL		280 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Acacia	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET, CHEWABLE / ORAL	3.7 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	ELIXIR / ORAL	0.24 mg		Exact identifier — unii candidate 6 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4e7a3618-3d32-4b77-8a3e-023d4eb65ee6			4a6c9e2d-58a3-4831-876c-644af778bdf6	2010-06-30	Warnings	Exact identifier spl id: 4e7a3618-3d32-4b77-8a3e-023d4eb65ee6 spl set id: 4a6c9e2d-58a3-4831-876c-644af778bdf6

Reported adverse events (FAERS/openFDA)#

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