Candee Caine Topical Anesthetic

Product NDC: 69301-059
11-digit product format: 693010059
Labeler code: 69301
Product ID: 69301-059_586924a0-322e-5dc3-e063-6294a90a1556
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL
Labeler: Top Quality Manufacturing, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-08-03
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: 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: Candee Caine Topical Anesthetic
Listing expiration: 2027-12-31

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
1992043	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
586924a0-322d-5dc3-e063-6294a90a1556	Available on FDA.report

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 26 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burkhart	STANNOUS FLUORIDE	Burkhart Dental Supply Inc	048c9978-e32e-4f77-9a4e-40acd5fcdfaf	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	aa09dcc0-e641-4c6d-8a84-ba890c0fce4c	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	4255da05-d264-4a4c-bd67-53d4862c0682	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	2282ea74-94c1-40be-a77f-290763a76250	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	99bce4c6-4593-40a1-b28d-8334a79b9d42	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	aa233c68-c6ac-44a5-b50e-3f5cd843bd25	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	bb11bfb4-1b50-48c6-8273-452b47b47833	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	867cef7b-fe6e-4a45-87c1-35579a681c6c	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	c6238079-0bcc-4c35-9b73-455252d41ee5	2025-01-09	Warnings	Exact identifier application number: M022
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	b144aca9-91d1-4106-a39c-b928192ad41e	2025-01-09	Warnings	Exact identifier application number: M022
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69301-059-30	69301005930	30 g in 1 JAR (69301-059-30)	30 g	2026-08-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Candee Caine Topical Anesthetic - Top Quality Manufacturing, Inc.	Top Quality Manufacturing, Inc.	2026-08-06	HUMAN OTC DRUG LABEL	1