BencoCaine Topical Anesthetic

Product NDC: 66975-355
11-digit product format: 669750355
Labeler code: 66975
Product ID: 66975-355_2b3a32cd-95ba-7651-e063-6394a90a3e38
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL
Labeler: Benco Dental
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-27
Substance: BENZOCAINE
Active strength: 200 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

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: BencoCaine Topical Anesthetic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	Internal RxNorm lookup
1541816	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
b6e25b54-4734-4769-9d1e-2d1187fdae19	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
66975-355-30	BencoCaine Topical Anesthetic	30 g in 1 JAR	GEL	30		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66975-355	BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]	5	Current NDC, Legacy NDC, 1 package rows	20250110_b6e25b54-4734-4769-9d1e-2d1187fdae19.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 25 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	0192ccf9-1715-4e23-a6bf-8bd838cd8b0d	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	edcb8451-6fa7-4bc2-95f6-2a0806f7f3da	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	576660ed-203a-4842-9d39-c5be10daf976	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	1796b3ec-833a-4cf1-ba50-bc4da827f84f	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	d923fa75-f556-45e3-9f52-39a62e89984b	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	cd3ede8c-2c77-4d81-8dff-8198025a2156	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f5f9b-4192-15e6-e053-2995a90a6457	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	2b494372-de59-e462-e063-6294a90a08da	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	a225d515-430d-4e34-846c-0bfec3e74109	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	372f99c9-4ad3-4631-b8c8-2a34c47343cc	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	e554b5b2-cf91-464a-a930-3e1087f12c8d	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	98da331c-76c2-49fe-b687-6bfba4ae2e75	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d2195efa-597d-4ba9-a9b0-8df0d8f49311	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	fba82d55-94db-4432-b532-603fe57202be	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	9ed0fe31-e5f2-4d6d-8686-1286c6659847	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d5f42c30-343c-4e1d-950c-89bbd361fd27	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	7dce407f-bbe4-4a27-97ff-be33fd447461	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f28f3-a908-47a9-e053-2995a90a6cbd	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	a80cfd29-8314-4639-a811-afd5fdb630b0	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
1541816	BencoCaine 20 % Oral Gel	PSN	b6e25b54-4734-4769-9d1e-2d1187fdae19	5
238910	benzocaine 20 % Oral Gel	PSN	b6e25b54-4734-4769-9d1e-2d1187fdae19	5
1541816	benzocaine 0.2 MG/MG Oral Gel [Bencocaine]	SBD	b6e25b54-4734-4769-9d1e-2d1187fdae19	5
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	b6e25b54-4734-4769-9d1e-2d1187fdae19	5
1541816	Bencocaine 20 % Oral Gel	SY	b6e25b54-4734-4769-9d1e-2d1187fdae19	5
1541816	Bencocaine 200 MG/GM Topical Oral Gel	SY	b6e25b54-4734-4769-9d1e-2d1187fdae19	5
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	b6e25b54-4734-4769-9d1e-2d1187fdae19	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66975-355-30	66975035530	30 g in 1 JAR (66975-355-30)	30 g	2018-06-01	0000-00-00	No	No	Current