Benzo-Jel

Product NDC: 0404-0033
11-digit product format: 004040033
Labeler code: 0404
Product ID: 0404-0033_2acfde41-0b79-ccba-e063-6294a90ac911
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL
Labeler: Henry Schein Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-05-01
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: Benzo-Jel
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
1053444	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
fb38b10d-0faf-403c-9921-d4f6b0f6aa55	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-0033-30	Benzo-Jel	30 g in 1 JAR	GEL	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-0033	BENZO-JEL (BENZOCAINE) GEL [HENRY SCHEIN INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250105_fb38b10d-0faf-403c-9921-d4f6b0f6aa55.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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART SALINE	SALINE NASAL (SODIUM CHLORIDE)	WALMART STORES INC	06906744-49a5-4bab-8539-af2d235df9e8	2025-10-28	Warnings	Exact identifier application number: M022
Saline	NASAL	PUBLIX SUPER MARKETS, INC	19841567-9511-43d6-ba4e-d1e1bd3481a4	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Fast Relief Oral Anesthetic	PHENOL	PUBLIX SUPER MARKETS, INC	89291f12-bbc3-4472-8ad3-a34485af72c9	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Menthol Flavor	PHENOL	PUBLIX SUPER MARKETS, INC	9296c49e-557c-43ed-9527-fcba5093a8dc	2025-10-28	Warnings	Exact identifier application number: M022
WinCo Foods Maximum Strength Oral Analgesic	BENZOCAINE	WinCo Foods, LLC	c22a7726-8c3f-41bf-b852-8456b2be6f93	2025-10-28	Warnings	Exact identifier application number: M022
Rugby Cherry Flavor	PHENOL	RUGBY LABORATORIES	3d668c78-8130-45d4-bcb7-dddcb2fbe7a3	2025-10-25	Warnings	Exact identifier application number: M022
LolliCaine Bubble Gum	BENZOCAINE	Centrix, Inc.	56ae3a84-6bca-4906-a03d-9d755e1fba3b	2025-10-24	Warnings	Exact identifier application number: M022
Diabetic Tussin Sore Throat Cherry	PHENOL	MEDTECH PRODUCTS INC	ab351229-5771-4c6c-92a8-721cc41c002f	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar Free	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	34e4234c-ed61-4795-99fe-d281cdb0af88	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	6b1a50d0-be54-4fcb-b5e2-b47abf3555c0	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Childrens Sore Throat Cherry	PHENOL	Prestige Brands Holdings, Inc.	38ff6922-1abe-4fa9-a74e-ede604f707b5	2025-10-23	Warnings	Exact identifier application number: M022
Boka Sensitive	POTASSIUM NITRATE	Karaka LLC	40be9fab-53db-c67a-e063-6394a90a48cb	2025-10-23	Warnings	Exact identifier application number: M022
Canker Care Plus	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	1ec960db-52d5-4d99-a7f7-a2e538d28724	2025-10-20	Warnings	Exact identifier application number: M022
meijer Sensitive EXTRA WHITENING	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	bbcffb88-0bd4-4883-bb83-0b7a1428ad12	2025-10-20	Warnings	Exact identifier application number: M022
Quality Choice Maximum Strength Oral Pain Relieving	BENZOCAINE	Chain Drug Marketing Association Inc	dbde8e7f-85d8-4083-b01a-3a7e410a7747	2025-10-17	Warnings	Exact identifier application number: M022
Quality Choice	BENZOCAINE	Chain Drug Marketing Association, Inc.	24c3c4a3-bd76-198d-e063-6394a90ad45a	2025-10-16	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Cardinal Health	b84203bd-23e9-427d-83d8-f4c88266e23c	2025-10-14	Warnings	Exact identifier application number: M022
Finafta	BENZOCAINE, GLYCERIN	Efficient Laboratories Inc.	03368603-3e11-c2fa-e063-6294a90a04ea	2025-10-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening Action	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	e8a62f24-1db6-45fb-b6e1-5e57103f82bc	2025-10-14	Warnings	Exact identifier application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT	POTASSIUM NITRATE, SODIUM FLUORIDE	Ashtel Studios, Inc.	bc74d2a6-fe34-44cf-b015-70ed4d47c933	2025-10-13	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
1053444	BENZO-JEL 20 % Oral Gel	PSN	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4
238910	benzocaine 20 % Oral Gel	PSN	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4
1053444	benzocaine 0.2 MG/MG Oral Gel [Benzo-Jel]	SBD	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4
1053444	Benzo-Jel 0.2 MG/MG Oral Gel	SY	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4
1053444	Benzo-Jel 20 % Oral Gel	SY	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-0033-30	00404003330	30 g in 1 JAR (0404-0033-30)	30 g	2018-06-01	0000-00-00	No	No	Current