Label at a glance#

ProductTokisan Sore Throat Relief

Active ingredientBENZOCAINE

Label structure8 sections

Indications and uses

Uses for the temporary relief of: Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

Label contents#

Full prescribing information#

Dose

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older, apply to affected area for at least one minute and then spit out. Use up to 4 times daily or as directed by doctor. Children under 12 years of age should be supervised in the used of the product. Children 2 years of age: Consult a doctor.

Warnings

WARNINGS SECTION

Warnings

Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: 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 persist or worsens. If pregnant or breast feeding, ask a health professional before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate and sorbitol

Uses

INDICATIONS & USAGE SECTION

Uses for the temporary relief of:

Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

Purpose

OTC - PURPOSE SECTION

DRUG FACTS PURPOSE

Benzocaine 5% Anesthetic

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings

Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: 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 persist or worsens. If pregnant or breast feeding, ask a health professional before use.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

ACTIVE INGREDIENTS PURPOSE

Benzocaine 5% Anesthetic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG FACTS

ACTIVE INGREDIENTS PURPOSE

Benzocaine 5% Anesthetic

Uses for the temporary relief of:

Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

Warnings

Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: 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 persist or worsens. If pregnant or breast feeding, ask a health professional before use.

Directions

Adults and children 2 years of age and older, apply to affected area for at least one minute and then spit out. Use up to 4 times daily or as directed by doctor. Children under 12 years of age should be supervised in the used of the product. Children 2 years of age: Consult a doctor.

Other Information

Store at room temperature (68-77F) (20-25C)

Do not freeze

Alcohol Free

Inactive ingredients

Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate and sorbitol.

Carton

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238909	benzocaine 5 % Topical Spray	PSN	1
1726835	Tokisan 5 % Topical Spray	PSN	1
1726835	benzocaine 50 MG/ML Topical Spray [Tokisan]	SBD	1
238909	benzocaine 50 MG/ML Topical Spray	SCD	1
238909	benzocaine 5 % Topical Spray	SY	1
1726835	Tokisan 5 % Topical Spray	SY	1
1726835	Tokisan 50 MG/ML Topical Spray	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11856-5001-1	2020-01-31	C162847	48780-1	9d75b9d1-02b5-f424-e053-dadaa90a57ce	227e7e75-3e7e-5ec3-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11856-5001-1	TokisanSore Throat Relief	1 in 1 BOX	LIQUID	1		1
11856-5001-1	TokisanSore Throat Relief	33 mL in 1 BOTTLE, SPRAY	LIQUID	33		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11856-5001	TOKISAN SORE THROAT RELIEF (BENZOCAINE) LIQUID [GOYESCAS OF FLA]	1	Legacy NDC, 2 package rows	20151216_227e7e75-3e7e-5ec3-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Tokisan Sore Throat Relief
Benzocaine
BENZALKONIUM CHLORIDE
EUCALYPTUS OIL
FD&C RED NO. 40
WATER
SODIUM BICARBONATE
SODIUM BORATE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11856-5001	11856-5001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
WATER	059QF0KO0R	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SORBITOL	506T60A25R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
227e7e75-3e7f-5ec3-e054-00144ff8d46c			227e7e75-3e7e-5ec3-e054-00144ff8d46c	2015-10-19	Warnings	Exact identifier spl id: 227e7e75-3e7f-5ec3-e054-00144ff8d46c spl set id: 227e7e75-3e7e-5ec3-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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