87786-001

Manufacturer
Wenzhou Yuyuan Pharmaceutical Co., Ltd.
Effective date
2026-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-17 05:10:12

Label at a glance#

ProductTideFresh MOUTH SORE AND TOOTHACHE
Active ingredientBENZOCAINE
Label structure12 sections

Dosage and administration

Remove protective cap before use; prime pump by pressing several times prior to initial application. Spray directly onto affected oral ulcer/sore area to form a thin protective coating. Adult supervision required when product is used by children. Adults and children 2 years of age and older: apply up to 4 times daily or as directed by a doctor/dentist. Children under 2 years of age: Do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral anesthetic/analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain and minor irritation of the mouth and gums due to canker sores.

Warnings

WARNINGS SECTION

Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before.

Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Do not use

OTC - DO NOT USE SECTION

for teething
in children under 2 years of age

When Using

OTC - WHEN USING SECTION

do not use for more than 7 days unless directed by a dentist or doctor and do not exceed recommended dosage.

Stop Use

OTC - STOP USE SECTION

if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops

Ask Doctor

OTC - ASK DOCTOR SECTION

if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Remove protective cap before use; prime pump by pressing several times prior to initial application.
Spray directly onto affected oral ulcer/sore area to form a thin protective coating.
Adult supervision required when product is used by children.
Adults and children 2 years of age and older: apply up to 4 times daily or as directed by a doctor/dentist.
Children under 2 years of age: Do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Aloe Barbadensis Leaf Extract,Butylated Hydroxytoluene, Cetylpyridinium Chloride, Chamomilla Recutita (Matricaria) Flower Extract, Cocos Nucifera (Coconut) Oil, Commiphora Myrrha Resin, Dimethicone, Echinacea Purpurea Extract, Glyceryl Stearate, Menthol, Mineral Oil, Silica Dimethicone Silylate, Tocopherol (Vitamin E), White Petrolatum

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2020

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136978887450390GTIN-13: 6978887450390
EAN-13: 6978887450390
GTIN storage (14 digits): 06978887450390
12b7611889a3ce67e21848eef8b59503.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87786-00187786-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
ndc (package): 87786-001-01
ndc (product): 87786-001
ndc11 (package): 87786000101
spl id: 541e1814-c00f-efdf-e063-6394a90a41a1
spl set id: 541e1814-c00e-efdf-e063-6394a90a41a1

Reported adverse events (FAERS/openFDA)#

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