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 20 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exchange Select Drops Sugar Free Lemon Mint	MENTHOL	Army & Air Force Exchange Service	3d70450f-04ea-1885-e063-6294a90a05bd	2025-08-28	Warnings	Exact identifier application number: M022
Ki No Sin	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	21fa2bad-5b8b-8aac-e063-6394a90a9f49	2025-08-27	Warnings	Exact identifier application number: M022
R Cos	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	21fa767a-1344-5ed9-e063-6394a90a5fe6	2025-08-27	Warnings	Exact identifier application number: M022
Na Mi Cal	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	20cfbcd1-eb13-933c-e063-6294a90a7e59	2025-08-27	Warnings	Exact identifier application number: M022
Ki No Sin	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	20cf8f80-c638-4d94-e063-6294a90a5400	2025-08-27	Warnings	Exact identifier application number: M022
Charm Tex FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Yangzhou Hongshengding Chemical Co.,Ltd.	63a69664-8611-4d69-b871-8d1d5b553e5c	2025-08-18	Warnings	Exact identifier application number: M022
QUALITY CHOICE SALINE	SODIUM CHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f51491d8-12ad-4b1b-a171-c621bfdcc341	2025-08-12	Warnings	Exact identifier application number: M022
MGC Health Drops Sugar Free Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	b9227966-847c-40c3-87f2-8bea3954ec84	2025-08-12	Warnings	Exact identifier application number: M022
Exchange Select Drops Sugar Free Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	5f4b1960-43ac-4c74-9410-210c48bd8a1b	2025-08-12	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	113cdb83-0fdd-40f2-8ee6-b771dca99713	2025-08-12	Warnings	Exact identifier application number: M022
Topcare Maximum Strength	BENZOCAINE	Topco Associates LLC	6586fcda-b232-46b4-8461-c0042a4127c6	2025-08-12	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	13bf31c1-78e3-459f-9249-b0b6e2c17a13	2025-08-12	Warnings	Exact identifier application number: M022
Rexall Maximum Strength	BENZOCAINE	Rexall	8f6e2780-cfb7-4bef-9b7d-13cb80d8923e	2025-08-12	Warnings	Exact identifier application number: M022
Walgreens Maximum Strength	BENZOCAINE	Walgreens	8f24309d-d393-455a-a9a5-a55344adf36b	2025-08-12	Warnings	Exact identifier application number: M022
Oral Anesthetic Liquid	BENZOCAINE	Meijer, Inc.	0321c480-e150-421d-e063-6294a90ad687	2025-08-12	Warnings	Exact identifier application number: M022
Walgreens Mouth Sore Relief	BENZOCAINE	Walgreens	253d7ea2-e48e-c7d7-e063-6394a90ae001	2025-08-12	Warnings	Exact identifier application number: M022
Charm Tex FLUORIDE Gel	SODIUM FLUORIDE	Yangzhou Hongshengding Chemical Co.,Ltd.	897b0102-1c96-4699-908e-a7b7e26cd29f	2025-08-08	Warnings	Exact identifier application number: M022
Meijer Enamel Guard	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer Distribution Inc	82bc95be-0a07-3f00-e053-2a91aa0a7438	2025-08-08	Warnings	Exact identifier application number: M022
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	ac398ff0-0010-4e13-8b89-dc986fd7f974	2025-08-08	Warnings	Exact identifier application number: M022
QUALITY CHOICE SALINE	PLUS SOOTHING ALOE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	4ae4e88a-aaa5-4195-bedc-622fd5cd9394	2025-07-30	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