GingiCaine Gel

Product NDC: 10129-035
11-digit product format: 101290035
Labeler code: 10129
Product ID: 10129-035_551e4115-9355-7ef8-e063-6394a90a5bd5
Type: HUMAN OTC DRUG
Nonproprietary name: GingiCaine Gel Banana 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10129-035		D	Discontinued by firm		2026-10-12
excluded package	package	10129-035	10129-035-03	D	Discontinued by firm		2026-10-12

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 · 60 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
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	10129-035-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10129-035-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10129-035-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10129-035-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	10129-035-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10129-035-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10129-035-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10129-035-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
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	10129-035-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10129-035-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10129-035-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10129-035-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	10129-035-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10129-035-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10129-035-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10129-035-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
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	10129-035-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10129-035-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10129-035-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10129-035-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
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	10129-035-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10129-035-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10129-035-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10129-035-03	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10129-035-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10129-035-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10129-035-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10129-035-03	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-035-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-035-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-035-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10129-035-03	D	Discontinued by firm	`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 product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-035-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-035-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-035-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10129-035-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10129-035-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10129-035-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10129-035-03	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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
62857d06-a829-4efa-e053-2991aa0a6d15	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
10129-035-01	2025-01-30	GingiCaine Gel, Banana
10129-035-01	2025-01-30	GingiCaine Gel, Banana
10129-035-03	2025-01-30	GingiCaine Gel, Banana
10129-035-03	2025-01-30	GingiCaine Gel, Banana
10129-035-05	2025-01-30	GingiCaine Gel, Banana
10129-035-05	2025-01-30	GingiCaine Gel, Banana
10129-035-01	2021-09-02	GingiCaine Gel, Banana
10129-035-01	2021-09-02	GingiCaine Gel, Banana
10129-035-03	2021-09-02	GingiCaine Gel, Banana
10129-035-03	2021-09-02	GingiCaine Gel, Banana
10129-035-05	2021-09-02	GingiCaine Gel, Banana
10129-035-05	2021-09-02	GingiCaine Gel, Banana
10129-035-01	2021-07-23	GingiCaine Gel, Banana
10129-035-01	2021-07-23	GingiCaine Gel, Banana
10129-035-03	2021-07-23	GingiCaine Gel, Banana
10129-035-03	2021-07-23	GingiCaine Gel, Banana
10129-035-05	2021-07-23	GingiCaine Gel, Banana
10129-035-05	2021-07-23	GingiCaine Gel, Banana

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10129-035-01	GingiCaine Gel	1 in 1 BOTTLE, PLASTIC	GEL	1	3
10129-035-03	GingiCaine Gel	1 in 1 BOTTLE, PLASTIC	GEL	1	3
10129-035-05	GingiCaine Gel	6 in 1 BOTTLE, PLASTIC	GEL	6	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10129-035	GINGICAINE GEL (GINGICAINE GEL BANANA FLAVOR) GEL [GINGI-PAK A DIVISION OF THE BELPORT]	3	Current NDC, Legacy NDC, 3 package rows	20211209_62857d06-a829-4efa-e053-2991aa0a6d15.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 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AHLO PRO Healthy Gums	CETYLPYRIDINIUM CHLORIDE	Gervest USA Inc	4f5a0ccb-26e5-ebb6-e063-6394a90abbc5	2026-04-13	Warnings	Exact identifier application number: M022
Crest Scope Original Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f1db6f4-acd7-a665-e063-6294a90a826b	2026-04-10	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	Walgreens	1e845299-178e-49ce-9d08-7e9d548a5a6d	2026-04-09	Warnings	Exact identifier application number: M022
Sore throat cherry	PHENOL	Walgreens	67bed85e-e1e2-49ba-98d6-dfd4e1cd6856	2026-04-08	Warnings	Exact identifier application number: M022
Health-Tec Topical Anesthetic	BENZOCAINE	Dental Health Products, Inc.	5eb437c5-a2af-4c0d-b7b9-9ab7d093db85	2026-04-06	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	269b9e7f-c5c8-4023-a3ea-e39040ade271	2026-04-06	Warnings	Exact identifier application number: M022
Health-Tec Topical Anesthetic	BENZOCAINE	Dental Health Products, Inc.	c3fb6705-c647-4fe6-9aca-29735d01d8ea	2026-04-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea	2026-04-01	Warnings	Exact identifier application number: M022
CloSYS Silver Healthy Gums	CETYLPYRIDINIUM CHLORIDE	Rowpar Pharmaceuticals, Inc.	11fd3f31-ee0c-43d2-a856-929d1298277c	2026-04-01	Warnings	Exact identifier application number: M022
Crest Pro-Health Bold Fresh Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	5692c0ce-a914-08c4-e063-6394a90adf15	2026-04-01	Warnings	Exact identifier application number: M022
Anticavity Fluoride	SODIUM FLUORIDE AND ACIDULATED PHOSPHATE	Family Dollar (FAMILY WELLNESS)	1666fff6-9a8b-40f9-ae53-914152db386b	2026-04-01	Warnings	Exact identifier application number: M022
Sodium Chloride Normal Salt	SODIUM CHLORIDE	TWIN MED LLC	10230c8a-e5e5-44f1-b41d-80930899d6b9	2026-03-31	Warnings	Exact identifier application number: M022
Sootheez Birthday Cake	PECTIN	Primrose Candy Co.	4e5d8234-0521-0c8a-e063-6294a90ae62d	2026-03-31	Warnings	Exact identifier application number: M022
Sootheez Watermelon Mint	PECTIN	Primrose Candy Co.	4e5e4342-4647-ef25-e063-6394a90a1d13	2026-03-31	Warnings	Exact identifier application number: M022
PERIOGELX	HYDROGEN PEROXIDE	PERIO PROTECT, LLC	4e5a67a0-f989-50df-e063-6394a90aae73	2026-03-31	Warnings	Exact identifier application number: M022
Periogel	HYDROGEN PEROXIDE	PERIO PROTECT, LLC	1f9686b1-eac2-65b7-e063-6394a90a74fb	2026-03-31	Warnings	Exact identifier application number: M022
PERIOGELX	HYDROGEN PEROXIDE	PERIO PROTECT, LLC	1f7ecd75-bb59-2f4f-e063-6294a90ace84	2026-03-31	Warnings	Exact identifier application number: M022
Baza Protect	ZINC OXIDE AND DIMETHICONE	Coloplast Corp	ed63df26-3879-46df-8e09-10be569b25be	2026-03-31	Warnings	Exact identifier application number: M022
Benzocaine 20%	BENZOCAINE 20%	PAI Holdings, LLC dba PAI Pharma	7fbce9a5-00dc-4a4a-8709-ab752bdf2f59	2026-03-25	Warnings	Exact identifier application number: M022
Kroger Extra Whitening	FLUORIDE	Kroger	e704c690-1383-4cd6-be85-28bdd9ff936b	2026-03-24	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	62857d06-a829-4efa-e053-2991aa0a6d15	3
543801	Gingicaine 20 % Oral Gel	PSN	62857d06-a829-4efa-e053-2991aa0a6d15	3
543801	benzocaine 0.2 MG/MG Oral Gel [Gingicaine]	SBD	62857d06-a829-4efa-e053-2991aa0a6d15	3
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	62857d06-a829-4efa-e053-2991aa0a6d15	3
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	62857d06-a829-4efa-e053-2991aa0a6d15	3
543801	Gingicaine 0.2 MG/MG Oral Gel	SY	62857d06-a829-4efa-e053-2991aa0a6d15	3
543801	Gingicaine 20 % Oral Gel	SY	62857d06-a829-4efa-e053-2991aa0a6d15	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10129-035-01	10129003501	1 GEL in 1 BOTTLE, PLASTIC (10129-035-01)	1 gel	2001-05-07	0000-00-00	No	No	Current
10129-035-03	10129003503	1 GEL in 1 BOTTLE, PLASTIC (10129-035-03)	1 gel	1993-07-06	0000-00-00	No	No	Current
10129-035-05	10129003505	6 GEL in 1 BOTTLE, PLASTIC (10129-035-05)	6 gel	1993-07-06	0000-00-00	No	No	Current