Orajel Gum Pain 3X Medicated

Product NDC: 10237-792
11-digit product format: 102370792
Labeler code: 10237
Product ID: 10237-792_6eb4fc21-aa24-44ff-bc5e-b43e92a47301
Type: HUMAN OTC DRUG
Nonproprietary name: benzocaine, menthol, zinc chloride
Dosage form: GEL
Route: TOPICAL
Labeler: Church & Dwight Co., Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-12-17
Substance: BENZOCAINE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength: 200; 1.5; 2.6 mg/g; mg/g; mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 Gum Pain 3X Medicated
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g
ZINC CHLORIDE	1.5 mg/g
MENTHOL, UNSPECIFIED FORM	2.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
86Q357L16B	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
2362013	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
9a1632ad-2b47-5653-e053-2995a90ae0d9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-792-12	Orajel Gum Pain 3X Medicated	1 in 1 PACKAGE	GEL	1	3
10237-792-12	Orajel Gum Pain 3X Medicated	3.5 g in 1 TUBE	GEL	3.5	3
10237-792-42	Orajel Gum Pain 3X Medicated	1 in 1 CARTON	GEL	1	3
10237-792-42	Orajel Gum Pain 3X Medicated	11.9 g in 1 TUBE	GEL	11.9	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-792	ORAJEL GUM PAIN 3X MEDICATED (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.]	3	Current NDC, Legacy NDC, 4 package rows	20240530_9a1632ad-2b47-5653-e053-2995a90ae0d9.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 39 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORCA Pain Reliever Putty with Menthol	MENTHOL	ORCA Products, LLC	188cb01a-3d0f-43d9-983e-6475c0c5b06e	2023-11-10	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	33fbdbc7-e10d-4181-926f-9b591b5b07e3	2023-11-08	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0d2c8c0c-4c72-4400-b3b5-ed578fa35167	2023-11-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Degasa, S.A. de C.V.	45ac0275-4c68-3897-e054-00144ff8d46c	2023-11-05	Warnings	Exact identifier application number: M022
Oral Pain Relief	BENZOCAINE	GERI-CARE PHARMACEUTICAL CORP	d294a39e-55f4-272d-e053-2995a90ab7f7	2023-10-31	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	e10c45e6-d37f-4650-b3e5-07719cc0ea49	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	886d949b-8db1-499c-a277-174f8bc29f34	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	fc8194af-2e77-4ad1-ae75-461dce3ed604	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	baf7d184-07ed-4491-a1fc-9a377b4b0110	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	033034af-c86c-4dbf-90eb-009c117024c6	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	658ada18-2334-4b4e-b08e-702fa127aa14	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	cad932e5-8d7f-4f20-b1c2-febd328152f0	2023-10-11	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	2c9519ab-320d-49da-9deb-97a6168fb088	2023-10-10	Warnings	Exact identifier application number: M022
Ioline	BENZOCAINE	Dharma Research, Inc.	b862c974-c024-42c3-986e-b65069437c7b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	651ea978-081d-4c59-b177-6049a69d9415	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	db763237-2910-45b9-be72-da092edc951b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	34316f93-10b4-41cc-8654-625283f0044c	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	142a8824-657e-492a-8e5a-b15eb73383c9	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	414cbec9-94e2-4bca-908b-1e79f8db0b27	2023-10-10	Warnings	Exact identifier application number: M022
Sore throat cherry	PHENOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de634cf1-ed39-4d8a-8855-006c69b7aee9	2023-10-10	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
86Q357L16B	ZINC CHLORIDE	7646-85-7	ZINC CHLORIDE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2362013	benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel	PSN	9a1632ad-2b47-5653-e053-2995a90ae0d9	3
2362013	benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel	SCD	9a1632ad-2b47-5653-e053-2995a90ae0d9	3
2362013	benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel	SY	9a1632ad-2b47-5653-e053-2995a90ae0d9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10237-792-12	10237079212	1 TUBE in 1 PACKAGE (10237-792-12) / 3.5 g in 1 TUBE	1 tube	2019-12-17	0000-00-00	No	No	Current
10237-792-42	10237079242	1 TUBE in 1 CARTON (10237-792-42) / 11.9 g in 1 TUBE	1 tube	2019-12-17		No	No	Current