GingiCaine Gel, Chocolate Mint

Product NDC: 10129-034
11-digit product format: 101290034
Labeler code: 10129
Product ID: 10129-034_556cb4b1-8f13-33c6-e063-6294a90a6892
Type: HUMAN OTC DRUG
Nonproprietary name: GingiCaine Gel, Chocolate Mint Flavor
Dosage form: GEL
Route: DENTAL; ORAL; PERIODONTAL
Labeler: Gingi-Pak a Division of the Belport
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1993-07-06
Substance: BENZOCAINE
Active strength: 200 mg/1
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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10129-034-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10129-034-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10129-034-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10129-034-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10129-034-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10129-034-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10129-034-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10129-034-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10129-034-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10129-034-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10129-034-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10129-034-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10129-034-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10129-034-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-034-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-034-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-034-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-034-05	U	Excluded because listing certification expired	`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: GingiCaine Gel, Chocolate Mint
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/1

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
543801	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
6285c4f2-c139-49a9-e053-2991aa0a2b03	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10129-034-01	2025-01-30	GingiCaine Gel, Chocolate Mint
10129-034-01	2025-01-30	GingiCaine Gel, Chocolate Mint
10129-034-05	2025-01-30	GingiCaine Gel, Chocolate Mint
10129-034-05	2025-01-30	GingiCaine Gel, Chocolate Mint
10129-034-01	2021-09-02	GingiCaine Gel, Chocolate Mint
10129-034-01	2021-09-02	GingiCaine Gel, Chocolate Mint
10129-034-05	2021-09-02	GingiCaine Gel, Chocolate Mint
10129-034-05	2021-09-02	GingiCaine Gel, Chocolate Mint
10129-034-01	2021-07-23	GingiCaine Gel, Chocolate Mint
10129-034-01	2021-07-23	GingiCaine Gel, Chocolate Mint
10129-034-05	2021-07-23	GingiCaine Gel, Chocolate Mint
10129-034-05	2021-07-23	GingiCaine Gel, Chocolate Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10129-034-01	GingiCaine Gel, Chocolate Mint	1 in 1 BOTTLE, PLASTIC	GEL	1		2
10129-034-05	GingiCaine Gel, Chocolate Mint	6 in 1 BOTTLE, PLASTIC	GEL	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10129-034	GINGICAINE GEL, CHOCOLATE MINT (GINGICAINE GEL, CHOCOLATE MINT FLAVOR) GEL [GINGI-PAK A DIVISION OF THE BELPORT]	2	Current NDC, Legacy NDC, 2 package rows	20211210_6285c4f2-c139-49a9-e053-2991aa0a2b03.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 22 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	9e1f7462-a052-4db4-bc59-cce437b695d0	2025-05-20	Warnings	Exact identifier application number: M022
Saline 1.5 FL OZ	SALINE	ALAINA HEALTHCARE PRIVATE LIMITED	f1bdbb25-6943-4828-9ae0-7d9783c18b5f	2025-05-19	Warnings	Exact identifier application number: M022
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry	FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	3573f149-2af9-4c86-e063-6294a90a7b3f	2025-05-18	Warnings	Exact identifier application number: M022
Bubble Gum Flavor For Kids 25g 50g	BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	354c1eda-ec5b-a8c7-e063-6294a90a871d	2025-05-16	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safeway, Inc.	8fe2f1df-3264-455d-b62c-953dce171c02	2025-05-16	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath Freshener	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	32b632bf-058d-447b-a7fb-a9dd05c1e2b8	2025-05-08	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Clear Mint	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	444f931d-5e38-4cda-97ba-98aa0b5fe4f6	2025-05-08	Warnings	Exact identifier application number: M022
Listerine Clinical Solutions Gum Health Icy Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	06e1122b-1100-43c0-e063-6394a90a2e78	2025-04-22	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	5260258a-bb1e-43d6-bce1-70a38778a64a	2025-04-14	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	TARGET Corporation	93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65	2025-04-14	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee467ec4-bd5e-644a-e053-2a95a90ac273	2025-04-10	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	TOP CARE (Topco Associates LLC)	94b47e74-5a07-4b47-884c-aef95ba555f0	2025-04-09	Warnings	Exact identifier application number: M022
Mouthwash	MENTHOL, METHYL SALICYLATE, THYMOL	Orazen Inc	873c43df-1d46-359b-e053-2a91aa0a4319	2025-04-07	Warnings	Exact identifier application number: M022
Sensodyne Complete Protection Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	e3cc3146-8aed-4f6b-a252-e379418c2b8d	2025-03-26	Warnings	Exact identifier application number: M022
Listerine Freshburst Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee1e1df9-74c6-d24b-e053-2a95a90a43d3	2025-03-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	edb9e374-4dba-5823-e053-2a95a90a3da5	2025-03-03	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Good Sense (Geiss, Destin & Dunn, Inc.)	cfe9be26-e4a4-413c-a602-2f5948e3bb7a	2025-03-03	Warnings	Exact identifier application number: M022
LISTERINE Original Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	78e2e172-09a4-4bf1-9871-d099c49087be	2025-02-28	Warnings	Exact identifier application number: M022
WHITE GLO CHARCOAL SENSITIVE	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	a5edb7fd-c637-5447-e053-2995a90a5a6f	2025-02-26	Warnings	Exact identifier application number: M022
Glorysmile Toothpaste.	GLORYSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	2ef48156-904d-e42a-e063-6394a90a3cd0	2025-02-25	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	6285c4f2-c139-49a9-e053-2991aa0a2b03	2
543801	Gingicaine 20 % Oral Gel	PSN	6285c4f2-c139-49a9-e053-2991aa0a2b03	2
543801	benzocaine 0.2 MG/MG Oral Gel [Gingicaine]	SBD	6285c4f2-c139-49a9-e053-2991aa0a2b03	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	6285c4f2-c139-49a9-e053-2991aa0a2b03	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	6285c4f2-c139-49a9-e053-2991aa0a2b03	2
543801	Gingicaine 0.2 MG/MG Oral Gel	SY	6285c4f2-c139-49a9-e053-2991aa0a2b03	2
543801	Gingicaine 20 % Oral Gel	SY	6285c4f2-c139-49a9-e053-2991aa0a2b03	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10129-034-01	10129003401	1 GEL in 1 BOTTLE, PLASTIC (10129-034-01)	1 gel	1993-07-06	0000-00-00	No	No	Current
10129-034-05	10129003405	6 GEL in 1 BOTTLE, PLASTIC (10129-034-05)	6 gel	1993-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GingiCaine Gel, Chocolate Mint	Gingi-Pak a Division of the Belport	2026-06-29	HUMAN OTC DRUG LABEL	3