Orajel 2X Medicated Gel

Product NDC: 10237-782
11-digit product format: 102370782
Labeler code: 10237
Product ID: 10237-782_262be295-4eb0-3136-e063-6294a90a7dcc
Type: HUMAN OTC DRUG
Nonproprietary name: Oral Pain Reliever
Dosage form: GEL
Route: TOPICAL
Labeler: Church & Dwight Co., Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-23
Substance: BENZOCAINE; MENTHOL
Active strength: 200; 2.6 mg/g; mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10237-782		D	Discontinued by firm	2026-10-05
excluded package	package	10237-782	10237-782-25	D	Discontinued by firm	2026-10-05
excluded package	package	10237-782	10237-782-42	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10237-782-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10237-782-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10237-782-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10237-782-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10237-782-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10237-782-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10237-782-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10237-782-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10237-782-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10237-782-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10237-782-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10237-782-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10237-782-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10237-782-42	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10237-782-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10237-782-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10237-782-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10237-782-42	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-782-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-782-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10237-782-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10237-782-42	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10237-782-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10237-782-42	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Medicated Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g
MENTHOL	2.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2117337	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
262be295-4eaf-3136-e063-6294a90a7dcc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10237-782-25	Orajel 2X Medicated Gel	7 g in 1 TUBE	GEL	7		1
10237-782-25	Orajel 2X Medicated Gel	1 in 1 CARTON	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-782	ORAJEL 2X MEDICATED GEL (ORAL PAIN RELIEVER) GEL [CHURCH & DWIGHT CO., INC.]	1	Current NDC, 2 package rows	20241109_262be295-4eaf-3136-e063-6294a90a7dcc.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 7 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lemon Glycerin	GLYCERIN	Dynarex Corporation	99fc00ea-9d55-0380-e053-2995a90a2c0b	2026-03-24	Warnings	Exact identifier application number: M022
Vicks VapoCool Sore Throat	BENZOCAINE AND MENTHOL	The Procter & Gamble Manufacturing Company	911a05de-cb3f-c1d2-e053-2995a90ae4be	2026-03-23	Warnings	Exact identifier application number: M022
Dual-FormulaToothpaste for sensitive teeth	DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH	Hangzhou Namei Zhikang Technology Co., Ltd.	4d735f91-8abc-3a30-e063-6394a90a7639	2026-03-20	Warnings	Exact identifier application number: M022
SmileCare Mouth Ulcer Gel	MENTHOL	Yantai Aien Biotechnology Co., Ltd.	4d6db039-5b97-8f3f-e063-6294a90a9d85	2026-03-19	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f91e609-8ca5-0492-e053-2a95a90a85d0	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f81ffa5-05fd-4eef-e053-2995a90aac3e	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947366-9380-3fa9-e053-2a95a90ad49c	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947672-4873-5546-e053-2a95a90a3c4b	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f9490c1-8bfe-3166-e053-2a95a90a7175	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	2026-03-17	Warnings	Exact identifier application number: M022
BencoCaine Topical Anesthetic	BENZOCAINE	Benco Dental	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	2026-03-17	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043c00a6-1346-7780-e063-6294a90a3d5a	2026-03-12	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	a5f0be98-d47e-4307-8044-304a64db774b	2026-03-11	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	a2f9d58b-671b-4427-a971-1fceff5f2323	2026-03-09	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	a5dbaadf-76a8-4c48-af2d-f4455e9411f0	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Sam's West, Inc	78a3e024-73da-40b7-9d9c-099fd6ca9b9e	2026-03-03	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	CVS PHARMACY, INC	9683bcfb-2f7e-48a4-aa79-500ee8df099a	2026-03-02	Warnings	Exact identifier application number: M022
Spring Gene Oil Pulling Sensitivity	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	294051e3-69ec-4190-8b03-fa34988376b7	2026-02-26	Warnings	Exact identifier application number: M022
Lolleez Watermelon	PECTIN	BFY LLC	4ba8af8b-5a17-8b8c-e063-6394a90a63f3	2026-02-25	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	H E B	f1450866-1be4-46d9-9fe4-52d699636b4f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2117337	benzocaine 20 % / menthol 0.26 % Oral Gel	PSN	262be295-4eaf-3136-e063-6294a90a7dcc	1
2117337	benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG Oral Gel	SCD	262be295-4eaf-3136-e063-6294a90a7dcc	1
2117337	benzocaine 20 % / menthol 0.26 % Oral Gel	SY	262be295-4eaf-3136-e063-6294a90a7dcc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10237-782-25	10237078225	1 TUBE in 1 CARTON (10237-782-25) / 7 g in 1 TUBE	1 tube	2022-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orajel 2X Medicated Gel - Church & Dwight Co., Inc.	Church & Dwight Co., Inc.	2024-11-05	HUMAN OTC DRUG LABEL	1