Orajel 2x Gum Pain

Product NDC: 10237-799
11-digit product format: 102370799
Labeler code: 10237
Product ID: 10237-799_27eb6e9e-5cd7-d08a-e063-6394a90ad5b6
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol and Hydrogen Peroxide
Dosage form: RINSE
Route: ORAL
Labeler: Church & Dwight Co., Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-15
Substance: MENTHOL, UNSPECIFIED FORM; HYDROGEN PEROXIDE
Active strength: 1; 15 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Orajel 2x Gum Pain
Brand name suffix: Alcohol-Free
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	1 mg/mL
HYDROGEN PEROXIDE	15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
BBX060AN9V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2584344	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
adf37010-922c-4441-93d6-1e1a95025e90	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10237-799-16	Orajel 2x Gum Pain Alcohol-Free	473.2 mL in 1 BOTTLE, PLASTIC	RINSE	473.2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-799	ORAJEL 2X GUM PAIN ALCOHOL-FREE (MENTHOL AND HYDROGEN PEROXIDE) RINSE [CHURCH & DWIGHT CO., INC.]	2	Current NDC, 1 package rows	20241129_adf37010-922c-4441-93d6-1e1a95025e90.zip

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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
BBX060AN9V	HYDROGEN PEROXIDE	7722-84-1	HYDROGEN PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2584344	hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution	PSN	adf37010-922c-4441-93d6-1e1a95025e90	2
2584344	hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical Solution	SCD	adf37010-922c-4441-93d6-1e1a95025e90	2
2584344	hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution	SY	adf37010-922c-4441-93d6-1e1a95025e90	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10237-799-16	10237079916	473.2 mL in 1 BOTTLE, PLASTIC (10237-799-16)	473.2 ml	2023-01-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orajel ™ 2x Gum Pain Rinse Alcohol-Free	Church & Dwight Co., Inc. \| Church & Dwight Canada Corp.	2024-11-27	HUMAN OTC DRUG LABEL	2