FDA.reportPublic FDA data

GingiCaine Gel, Chocolate Mint

Product NDC
10129-034
Requested package NDC
10129-034-01
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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
BENZOCAINE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238910Internal RxNorm lookup
543801Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6285c4f2-c139-49a9-e053-2991aa0a2b03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10129-034-012025-01-30GingiCaine Gel, Chocolate Mint
10129-034-012025-01-30GingiCaine Gel, Chocolate Mint
10129-034-052025-01-30GingiCaine Gel, Chocolate Mint
10129-034-052025-01-30GingiCaine Gel, Chocolate Mint
10129-034-012021-09-02GingiCaine Gel, Chocolate Mint
10129-034-012021-09-02GingiCaine Gel, Chocolate Mint
10129-034-052021-09-02GingiCaine Gel, Chocolate Mint
10129-034-052021-09-02GingiCaine Gel, Chocolate Mint
10129-034-012021-07-23GingiCaine Gel, Chocolate Mint
10129-034-012021-07-23GingiCaine Gel, Chocolate Mint
10129-034-052021-07-23GingiCaine Gel, Chocolate Mint
10129-034-052021-07-23GingiCaine Gel, Chocolate Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10129-034-01GingiCaine Gel, Chocolate Mint1 in 1 BOTTLE, PLASTICGEL12
10129-034-05GingiCaine Gel, Chocolate Mint6 in 1 BOTTLE, PLASTICGEL62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10129-034GINGICAINE GEL, CHOCOLATE MINT (GINGICAINE GEL, CHOCOLATE MINT FLAVOR) GEL [GINGI-PAK A DIVISION OF THE BELPORT]2Current NDC, Legacy NDC, 2 package rows20211210_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 18 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
application number: M022
DuoCare Clinical Oral RinseCETYLPYRIDINIUM CHLORIDEMedline Industries, LP98e61cd5-7e29-7066-e053-2a95a90afa212025-10-10WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd40b756b7-ce1b-6482-e063-6294a90a04252025-10-09WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEGil Pharmaceutical Corp85053391-8d71-ab4f-e053-2991aa0a7e082025-10-09WarningsExact identifier
application number: M022
Listerine Gum Therapy Mouthwash Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC40a0bdf3-1698-1449-e063-6394a90ab13d2025-10-08WarningsExact identifier
application number: M022
Kalaya Breath RefreshMOUTHWASHAvaria Health and Beauty Corp750e99ff-72e4-3c2f-e053-2a91aa0ad5a02025-10-08WarningsExact identifier
application number: M022
Trader JoesSODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%TRADER JOE'S COMPANY159abeba-6da2-2643-e063-6394a90a730d2025-10-08WarningsExact identifier
application number: M022
Family Wellness Oral Pain ReliefBENZOCAINE 20%FAMILY DOLLAR SERVICES INC105d87d6-9147-43d4-e063-6394a90a57ee2025-10-08WarningsExact identifier
application number: M022
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
application number: M022
Mouth Sore Relief Professional StrengthBENZOCAINECVS Pharmacy1b7209f6-8368-47fa-8df2-b049613b8c1b2025-09-30WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEFamily Dollar (FAMILY WELLNESS)9db73da2-5b70-41e6-bcf9-caa7f11420242025-09-29WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic LiquidCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47d7e1-b6ae-efd1-e063-6394a90a46022025-09-27WarningsExact identifier
application number: M022
Chloraseptic Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.d5d62f7a-8f92-4d42-a2fb-691f896f72fc2025-09-26WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEDextrum Laboratories Inc.3fa233dc-156c-1e95-e063-6294a90a8bbd2025-09-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEDextrum Laboratories Inc.cb027ab8-4175-4cc0-a73e-991dfb113df92025-09-23WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
application number: M022
Dental ReliefBENZOCAINECintas Corporation0f40f775-797e-43cf-88c9-00eea666494f2025-09-23WarningsExact identifier
application number: M022
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
application number: M022
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
application number: M022
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN6285c4f2-c139-49a9-e053-2991aa0a2b032
543801Gingicaine 20 % Oral GelPSN6285c4f2-c139-49a9-e053-2991aa0a2b032
543801benzocaine 0.2 MG/MG Oral Gel [Gingicaine]SBD6285c4f2-c139-49a9-e053-2991aa0a2b032
238910benzocaine 0.2 MG/MG Oral GelSCD6285c4f2-c139-49a9-e053-2991aa0a2b032
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY6285c4f2-c139-49a9-e053-2991aa0a2b032
543801Gingicaine 0.2 MG/MG Oral GelSY6285c4f2-c139-49a9-e053-2991aa0a2b032
543801Gingicaine 20 % Oral GelSY6285c4f2-c139-49a9-e053-2991aa0a2b032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10129-034-01101290034011 GEL in 1 BOTTLE, PLASTIC (10129-034-01) 1 gel1993-07-060000-00-00NoNoCurrent