UltraCare Anesthetic Gel

Product NDC: 10129-071
11-digit product format: 101290071
Labeler code: 10129
Product ID: 10129-071_552ed026-466f-4311-e063-6394a90ad1b6
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL; PERIODONTAL; TOPICAL
Labeler: The Bellport Company, Inc. dba Gingi-Pak
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-08
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-071-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-071-01	`0efc9e666f02…`	`f202fb6c5f17…`

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: UltraCare Anesthetic Gel
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	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
f5dd8fa8-0b6a-5a30-e053-2995a90ad194	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10129-071-01	UltraCare Anesthetic Gel	30 g in 1 BOTTLE	GEL	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10129-071	ULTRACARE ANESTHETIC GEL (BENZOCAINE) GEL [THE BELLPORT COMPANY, INC. DBA GINGI-PAK]	2	Current NDC, 1 package rows	20250130_f5dd8fa8-0b6a-5a30-e053-2995a90ad194.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	f5dd8fa8-0b6a-5a30-e053-2995a90ad194	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	f5dd8fa8-0b6a-5a30-e053-2995a90ad194	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	f5dd8fa8-0b6a-5a30-e053-2995a90ad194	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10129-071-01	10129007101	30 g in 1 BOTTLE (10129-071-01)	30 g	2023-02-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UltraCare	The Bellport Company, Inc. dba Gingi-Pak \| Jeff Nichols \| The Belport Company, Inc. dba Gingi-Pak	2026-06-26	HUMAN OTC DRUG LABEL	3