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	2026-10-12
excluded package	package	10237-782	10237-782-25	D	Discontinued by firm	2026-10-12
excluded package	package	10237-782	10237-782-42	D	Discontinued by firm	2026-10-12

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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	af430cf4-f1b4-4b57-b8e3-87df96d655d3	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	2b089fec-cae3-4dc9-964d-d37f732a2f9f	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	6c137a93-4a34-4849-997f-bd0c572466ef	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	e8aa9709-e8f6-47a6-ab29-1fef2309786b	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	8c55b39c-8231-46a1-92ef-9fb4e3f40c1e	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	9e82dc54-aeca-457f-b4b9-2f18cc269538	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	1a8f5964-770a-4d14-a7b6-18b5da9159b0	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722cdf3-7671-eb27-e053-2a95a90a09c4	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722bf24-ae85-54f6-e053-2995a90a1d35	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721864d-0950-8379-e053-2a95a90a3bcb	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	b0e5dc67-da7a-42ac-8657-e8e4da6914be	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721ff57-0111-4bbb-e053-2995a90a1a70	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	8129e871-5f31-4138-ae47-f8978fa6287f	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	0301c1bc-db48-4635-97f5-9eaef7ab9579	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	c0c88180-ccdc-4c48-b262-3ec20d4775d4	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	ba011795-6822-4fff-b9c8-5c91cf9972a7	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	462a5f09-131f-4dfa-a502-547c44e4a4a5	2025-01-16	Warnings	Exact identifier application number: M022
Benzocaine	TOPICAL ANESTHETIC	Everpharm LLC	2bc57111-0f15-b237-e063-6294a90a4471	2025-01-15	Warnings	Exact identifier application number: M022
Kanka Triple Action	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	078fcdab-38a1-4a9a-bdd3-e17446591ea8	2025-01-09	Warnings	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