Drug Facts

Manufacturer
Kungpo Health Care & Herbal Center Inc | Zhejiang Jingwei Pharmaceutical Co., Ltd
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
33048
Source
full-release
Hydrated at
2026-06-01 01:54:42

Label at a glance#

ProductOra YoGu 4X Medicated Tooth and Gum Pain Reliever
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, MENTHOL, ZINC CHLORIDE
Label structure13 sections

Indications and uses

Temporarily relieves pain caused by minor oral and gum injuries. First aid to help prevent infection from minor oral irritations. Improves loose teeth and maintains dental health.

Dosage and administration

Adult and children 2 years of age and over - Apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children between 2 and 12 years of age - Ask a doctor before use. Should be supervised in using this product. Children under 2 years of age - Do not use. Do not use if Amper-Evident Tab is open before first use. Avoid using toothpaste or drinking soft drinks or fruit juices for at least on...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride    0.13%
Benzocaine      20%
Menthol      0.26%
Zinc Chloride       0.15%

Purpose

OTC - PURPOSE SECTION

Benzalkonium Chloride     Oral Antibacterial 
Benzocaine       Oral Antibacterial     
Menthol      Oral Antibacterial
Zinc Chloride      Oral Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves pain caused by minor oral and gum injuries.
  • First aid to help prevent infection from minor oral irritations.
  • Improves loose teeth and maintains dental health.

Warning

WARNINGS SECTION

Use of this product may cause methemoglobinemia, a serious condition that requires immediate treatment because it reduces the oxygen-carrying capacity of the blood. This can happen even if you have used this product before.

Do not use

OTC - DO NOT USE SECTION

  • Do not use this product if you have a history of allergy to procaine, butacaine, benzocaine, or other "caine" class local anesthetics. 
  • Do not exceed the recommended dosage for more than 7 days unless directed by a dentist or doctor.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Stop use and seek immediate medical attention if you or 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
  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain, or redness persists or worsens.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or allergic reaction, get medical help or contact a poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adult and children 2 years of age and over - Apply to affected area up to 4 times daily or as directed by a dentist or doctor.
  • Children between 2 and 12 years of age - Ask a doctor before use. Should be supervised in using this product.
  • Children under 2 years of age - Do not use.
  • Do not use if Amper-Evident Tab is open before first use.
  • Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

Other information

OTHER SAFETY INFORMATION

  • This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.
  • Do not use if Temper-Evident Tab is open before first use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

POLYETHYLENE GLYCOL 300, POLYETHYLENE GLYCOL 3000, SACCHARIN SODIUM, SORBIC ACID, CINNAMON, SALT SUBSTITUTE, SCHISANDRA CHINENSIS SEED, CYPERUS ROTUNDUS FRUIT

Manufactured by

SPL UNCLASSIFIED SECTION

Zhejiang Jingwei Pharmaceutical Co., Ltd
Changshan Industrial Park, Zhejiang, China
Product of China

Imported and distributed by

SPL UNCLASSIFIED SECTION

KUNGPO HEALTH CARE & HERBAL CENTER INC.
1155 S. Milliken Ave, Suite H,
Ontario, CA 91761
Phone: 909-377-6878

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87351-761-10Ora YoGu 4X Medicated Tooth and Gum Pain Reliever10 mL in 1 TUBEGEL1033048
87351-761-10Ora YoGu 4X Medicated Tooth and Gum Pain Reliever1 in 1 PACKAGEGEL133048

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87351-76187351-761-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
ndc (package): 87351-761-10
ndc (product): 87351-761
ndc11 (package): 87351076110
spl id: fa8ae828-9f80-42f2-b23b-21d6c4bcb383
spl set id: 1f10a72f-0b49-41cb-92f9-b0160d7664de

Reported adverse events (FAERS/openFDA)#

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