Ora YoGu 4X Medicated Tooth and Gum Pain Reliever

Product NDC
87351-761
11-digit product format
873510761
Labeler code
87351
Product ID
87351-761_fa8ae828-9f80-42f2-b23b-21d6c4bcb383
Type
HUMAN OTC DRUG
Nonproprietary name
Medicated Tooth and Gum Pain Reliever
Dosage form
GEL
Route
TOPICAL
Labeler
Kungpo Health Care & Herbal Center Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-15
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength
.13; 20; .26; .15 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL
BENZOCAINE20 g/100mL
MENTHOL.26 g/100mL
ZINC CHLORIDE.15 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5, L7T10EIP3A, 86Q357L16B

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87351-761-10873510761101 TUBE in 1 PACKAGE (87351-761-10) / 10 mL in 1 TUBE1 tube2026-04-15NoNoHistorical