Alpha-Caine

Product NDC: 55346-2904
11-digit product format: 553462904
Labeler code: 55346
Product ID: 55346-2904_42c867a1-27bc-d7bb-e063-6394a90a1b49
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL; PERIODONTAL
Labeler: Dental Technologies, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1999-12-31
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: Alpha-Caine
Brand name suffix: 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
1297832	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
e6a312e5-17ac-46f0-8723-4e40eeecd69f	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
55346-2904-1	Alpha-CaineTopical Anesthetic	30 g in 1 BOTTLE, PLASTIC	GEL	30		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	4
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	4
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	4
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	4
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55346-2904	ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20231216_e6a312e5-17ac-46f0-8723-4e40eeecd69f.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 39 · 779 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
1297832	ALPHA-CAINE 20 % Oral Gel	PSN	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9
238910	benzocaine 20 % Oral Gel	PSN	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9
1297832	benzocaine 0.2 MG/MG Oral Gel [Alpha-caine]	SBD	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9
1297832	Alpha-caine 0.2 MG/MG Oral Gel	SY	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9
1297832	Alpha-caine 20 % Oral Gel	SY	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	e6a312e5-17ac-46f0-8723-4e40eeecd69f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55346-2904-1	55346290401	30 g in 1 BOTTLE, PLASTIC (55346-2904-1)	30 g	1999-12-31	0000-00-00	No	No	Current