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 11 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB Extra Whitening	FLUORIDE	HEB	b76c3591-6383-4661-b3db-7a56b11202f7	2026-01-08	Warnings	Exact identifier application number: M022
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	fc86b98e-d556-4769-e053-6394a90afc6e	2026-01-08	Warnings	Exact identifier application number: M022
Care One Maximum Strength	FLUORIDE	American Sales	1b6618ea-6533-41d7-be2c-13bb9e108dc5	2026-01-08	Warnings	Exact identifier application number: M022
equate Sensitive	POTASSIUM NITRATE, SODIUM FLUORIDE	Wal-Mart Stores Inc	79899b59-3a16-6504-e053-2991aa0a895a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	451283d3-78b0-8361-e063-6294a90a1fd5	2026-01-08	Warnings	Exact identifier application number: M022
CVS Maximum Strength	BENZOCAINE	CVS Pharmacy	8691d6b6-741e-47b2-8332-76742b34715f	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Gel	BENZOCAINE	Publix Super Markets INC	16eb9d15-dba3-36e6-e063-6394a90ab859	2026-01-08	Warnings	Exact identifier application number: M022
Toothache and Gum Relief	BENZOCAINE, MENTHOL	CVS Pharmacy	814ec7bf-f825-1095-e053-2a91aa0aee59	2026-01-08	Warnings	Exact identifier application number: M022
Lemon	GLYCERIN	Sion Biotext Medical Ltd	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	2026-01-08	Warnings	Exact identifier application number: M022
Sootheez Organic Wild Cherry	PECTIN	BFY LLC	47baa2a8-270c-fa07-e063-6394a90a97f6	2026-01-06	Warnings	Exact identifier application number: M022
Parodontax Gum Strengthen and Protect	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	3bb378c8-14b2-aa13-e063-6294a90a4db3	2026-01-05	Warnings	Exact identifier application number: M022
MySweetSmile Toothpaste.	MYSWEETSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478baf87-9276-7288-e063-6294a90a9e8e	2026-01-04	Warnings	Exact identifier application number: M022
MySweetSmile Mango Toothpaste.	MYSWEETSMILE MANGO TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478cbdeb-28e1-fa56-e063-6294a90af124	2026-01-04	Warnings	Exact identifier application number: M022
Smile Paint	SODIUM FLUORIDE	JABBER JAW KIDS TOOTHPASTE LLC	a7463b5c-53b2-4353-a5ea-800fbd7bd17d	2026-01-02	Warnings	Exact identifier application number: M022
Dentek Canker Cover	MENTHOL	Bershtel Enterprises	2669183c-7a58-037e-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	05929148-bffe-439f-a9d4-3170816c0fa2	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	37a4e712-e3b5-42f6-971c-98dea4b8dd06	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	6bcd35f5-18ea-4fc8-84cd-06db73f38a1e	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	e7bf7e31-650d-4a1c-9100-48722344b201	2025-12-31	Warnings	Exact identifier application number: M022
Normal Salt	SODIUM CHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	f3f09817-8a38-4aa1-956b-69d9cf695074	2025-12-25	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