FDA.reportPublic FDA data

Gingicaine Gel Strawberry

Product NDC
10129-036
11-digit product format
101290036
Labeler code
10129
Product ID
10129-036_50cb6dbf-74de-4f3a-e063-6394a90a21bb
Type
HUMAN OTC DRUG
Nonproprietary name
Gingicaine Gel Strawberry 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

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 Strawberry
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
2fd37612-a28b-3aa1-e054-00144ff8d46cAvailable 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
10129-036-012026-01-29Gingicaine Gel, Strawberry
10129-036-012026-01-29Gingicaine Gel, Strawberry
10129-036-042026-01-29Gingicaine Gel, Strawberry
10129-036-042026-01-29Gingicaine Gel, Strawberry
10129-036-052026-01-29Gingicaine Gel, Strawberry
10129-036-052026-01-29Gingicaine Gel, Strawberry
10129-036-012024-03-06Gingicaine Gel, Strawberry
10129-036-012024-03-06Gingicaine Gel, Strawberry
10129-036-042024-03-06Gingicaine Gel, Strawberry
10129-036-042024-03-06Gingicaine Gel, Strawberry
10129-036-052024-03-06Gingicaine Gel, Strawberry
10129-036-052024-03-06Gingicaine Gel, Strawberry
10129-036-012023-01-30Gingicaine Gel, Strawberry
10129-036-012023-01-30Gingicaine Gel, Strawberry
10129-036-042023-01-30Gingicaine Gel, Strawberry
10129-036-042023-01-30Gingicaine Gel, Strawberry
10129-036-052023-01-30Gingicaine Gel, Strawberry
10129-036-052023-01-30Gingicaine Gel, Strawberry
10129-036-012021-09-02Gingicaine Gel, Strawberry
10129-036-012021-09-02Gingicaine Gel, Strawberry
10129-036-042021-09-02Gingicaine Gel, Strawberry
10129-036-042021-09-02Gingicaine Gel, Strawberry
10129-036-052021-09-02Gingicaine Gel, Strawberry
10129-036-052021-09-02Gingicaine Gel, Strawberry
10129-036-012021-07-23Gingicaine Gel, Strawberry
10129-036-012021-07-23Gingicaine Gel, Strawberry
10129-036-042021-07-23Gingicaine Gel, Strawberry
10129-036-042021-07-23Gingicaine Gel, Strawberry
10129-036-052021-07-23Gingicaine Gel, Strawberry
10129-036-052021-07-23Gingicaine Gel, Strawberry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10129-036-01Gingicaine Gel Strawberry1 in 1 BOTTLE, PLASTICGEL112
10129-036-04Gingicaine Gel Strawberry20 in 1 SYRINGE, PLASTICGEL2012
10129-036-05Gingicaine Gel Strawberry6 in 1 BOTTLE, PLASTICGEL612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10129-036GINGICAINE GEL STRAWBERRY (GINGICAINE GEL STRAWBERRY FLAVOR) GEL [GINGI-PAK A DIVISION OF THE BELPORT]12Current NDC, Legacy NDC, 3 package rows20240308_2fd37612-a28b-3aa1-e054-00144ff8d46c.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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Mouth CleanserHYDROGEN PEROXIDEMeijer, Inc.c9c17224-9304-403a-b6a1-9c8bd94e3d942026-02-19Warnings, Adverse reactionsExact identifier
application number: M022
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
application number: m022
Sore Mouth CleanserHYDROGEN PEROXIDEWalgreen Co.33223589-4ff4-4e4e-96da-6fa2e4d0f1872026-02-12Warnings, Adverse reactionsExact identifier
application number: M022
PERIOSCIENCES SENSITIVE AO ProPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLCacca8964-b575-468c-8b40-514dfbf507782026-02-09WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)e19228e9-6f87-456e-a222-f979a234d5892026-02-06WarningsExact identifier
application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
application number: M022
Sootheez Strawberry LemonadePECTINPrimrose Candy Co.49e2b303-1018-cd13-e063-6394a90ae3002026-02-02WarningsExact identifier
application number: M022
Sootheez Berry LemonadePECTINPrimrose Candy Co.49cee56f-c45f-6c79-e063-6294a90a5f8f2026-02-01WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDERite Aid Corporation294418aa-640d-42be-ad07-de31da7a7ccc2026-01-30Warnings, Adverse reactionsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
application number: M022
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
application number: M022
Crest Pro-Health All Day Clean BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company48eaca4c-19c2-2dd2-e063-6394a90a3e082026-01-21WarningsExact identifier
application number: M022
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINEUniversal Distribution Center LLCe276ba37-46fb-4ed9-9ee1-c08a2a89704a2026-01-20WarningsExact identifier
application number: M022
Equate Orasol20% BENZOCAINEWAL-MART STORES INC.08404780-8252-4484-b1c3-8970803f74f82026-01-19WarningsExact identifier
application number: M022
Equate Healthy MouthCPC 0.05% ANTIPLAQUE/ANTI-GINGIVITISWalmart, Inc.1cc1f6fd-67d4-b314-e063-6294a90ab9952026-01-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN2fd37612-a28b-3aa1-e054-00144ff8d46c12
543801Gingicaine 20 % Oral GelPSN2fd37612-a28b-3aa1-e054-00144ff8d46c12
543801benzocaine 0.2 MG/MG Oral Gel [Gingicaine]SBD2fd37612-a28b-3aa1-e054-00144ff8d46c12
238910benzocaine 0.2 MG/MG Oral GelSCD2fd37612-a28b-3aa1-e054-00144ff8d46c12
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY2fd37612-a28b-3aa1-e054-00144ff8d46c12
543801Gingicaine 0.2 MG/MG Oral GelSY2fd37612-a28b-3aa1-e054-00144ff8d46c12
543801Gingicaine 20 % Oral GelSY2fd37612-a28b-3aa1-e054-00144ff8d46c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10129-036-01101290036011 GEL in 1 BOTTLE, PLASTIC (10129-036-01) 1 gel1993-07-060000-00-00NoNoCurrent
10129-036-041012900360420 GEL in 1 SYRINGE, PLASTIC (10129-036-04) 20 gel2018-01-110000-00-00NoNoCurrent
10129-036-05101290036056 GEL in 1 BOTTLE, PLASTIC (10129-036-05) 6 gel1993-07-060000-00-00NoNoCurrent