Oral Gel

Product NDC: 83650-101
11-digit product format: 836500101
Labeler code: 83650
Product ID: 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine Benzalkonium Chloride
Dosage form: GEL
Route: TOPICAL
Labeler: Savvy Care and Cosmetics
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-09-22
Substance: BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength: 20; .1 g/100g; g/100g
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: Oral Gel
Brand name suffix: Oral Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 g/100g
BENZALKONIUM CHLORIDE	.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1595155	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
05ede7e4-5a0a-c942-e063-6294a90a8a24	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83650-101-01	Oral GelOral Pain Relief	42.5 g in 1 TUBE	GEL	42.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83650-101	ORAL GEL ORAL PAIN RELIEF (BENZOCAINE BENZALKONIUM CHLORIDE) GEL [SAVVY CARE AND COSMETICS]	2	Current NDC, 1 package rows	20241222_05ede7e4-5a0a-c942-e063-6294a90a8a24.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 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
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1595155	benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel	PSN	05ede7e4-5a0a-c942-e063-6294a90a8a24	2
1595155	benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel	SCD	05ede7e4-5a0a-c942-e063-6294a90a8a24	2
1595155	benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel	SY	05ede7e4-5a0a-c942-e063-6294a90a8a24	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83650-101-01	83650010101	42.5 g in 1 TUBE (83650-101-01)	42.5 g	2023-09-22	No	No	Current