FDA.reportPublic FDA data

Gingicaine Gel Strawberry

Product NDC
10129-036
Requested package NDC
10129-036-01
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 24 of 39 · 779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee2025-01-09WarningsExact identifier
application number: M022
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc6d8078e9-b0d8-4220-b90a-3f14fa0e43f42025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc26128466-939b-445f-aa64-04c7283d306c2025-01-09WarningsExact identifier
application number: M022
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc048c9978-e32e-4f77-9a4e-40acd5fcdfaf2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa09dcc0-e641-4c6d-8a84-ba890c0fce4c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc4255da05-d264-4a4c-bd67-53d4862c06822025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc2282ea74-94c1-40be-a77f-290763a762502025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc99bce4c6-4593-40a1-b28d-8334a79b9d422025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa233c68-c6ac-44a5-b50e-3f5cd843bd252025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incbb11bfb4-1b50-48c6-8273-452b47b478332025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc867cef7b-fe6e-4a45-87c1-35579a681c6c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incc6238079-0bcc-4c35-9b73-455252d41ee52025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incb144aca9-91d1-4106-a39c-b928192ad41e2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.0192ccf9-1715-4e23-a6bf-8bd838cd8b0d2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.edcb8451-6fa7-4bc2-95f6-2a0806f7f3da2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.576660ed-203a-4842-9d39-c5be10daf9762025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.1796b3ec-833a-4cf1-ba50-bc4da827f84f2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.d923fa75-f556-45e3-9f52-39a62e89984b2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.cd3ede8c-2c77-4d81-8dff-8198025a21562025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact 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