BencoCaine Topical Anesthetic

Product NDC: 66975-360
11-digit product format: 669750360
Labeler code: 66975
Product ID: 66975-360_4d3e03ee-6e10-c9ae-e063-6394a90a6f5b
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: SPRAY, METERED
Route: DENTAL
Labeler: Benco Dental
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-12-01
Substance: BENZOCAINE
Active strength: 11.4 g/57g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	11.4 g/57g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1435490	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
4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66975-360-35	BencoCaine Topical Anesthetic	57 g in 1 BOTTLE, SPRAY	SPRAY, METERED	57		1

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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	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
1435490	benzocaine 20 % Oral Spray	PSN	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	1
1435490	benzocaine 200 MG/ML Oral Spray	SCD	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	1
1435490	benzocaine 20 % Oral Spray	SY	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66975-360-35	66975036035	57 g in 1 BOTTLE, SPRAY (66975-360-35)	57 g	2021-12-01	No	No	Current