Home NDC 10129-033-05 GingiCaine Gel, Pina Colada
Product NDC 10129-033
Requested package NDC 10129-033-05
11-digit product format 101290033
Labeler code 10129
Product ID 10129-033_556c6a5b-f738-8d09-e063-6294a90af0b9
Type HUMAN OTC DRUG
Nonproprietary name GingiCaine Gel, Pina Colada 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 date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 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, Pina Colada
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 10129-033-01 2025-01-30 GingiCaine Gel, Pina Colada 10129-033-01 2025-01-30 GingiCaine Gel, Pina Colada 10129-033-05 2025-01-30 GingiCaine Gel, Pina Colada 10129-033-05 2025-01-30 GingiCaine Gel, Pina Colada 10129-033-01 2021-09-02 GingiCaine Gel, Pina Colada 10129-033-01 2021-09-02 GingiCaine Gel, Pina Colada 10129-033-05 2021-09-02 GingiCaine Gel, Pina Colada 10129-033-05 2021-09-02 GingiCaine Gel, Pina Colada 10129-033-01 2021-07-23 GingiCaine Gel, Pina Colada 10129-033-01 2021-07-23 GingiCaine Gel, Pina Colada 10129-033-05 2021-07-23 GingiCaine Gel, Pina Colada 10129-033-05 2021-07-23 GingiCaine Gel, Pina Colada
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10129-033-01 GingiCaine Gel, Pina Colada 1 in 1 BOTTLE, PLASTIC GEL 1 2 10129-033-05 GingiCaine Gel, Pina Colada 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 10129-033 GINGICAINE GEL, PINA COLADA (GINGICAINE GEL, PINA COLADA FLAVOR) GEL [GINGI-PAK A DIVISION OF THE BELPORT] 2 Current NDC, Legacy NDC, 2 package rows 20211210_6284e1fe-be33-69bf-e053-2991aa0a90ab.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 30 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Benzo-Jel BENZOCAINE Henry Schein Inc. bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. fb38b10d-0faf-403c-9921-d4f6b0f6aa55 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. a9dc2245-c029-4453-bfc5-8fb899873c34 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. ba49a18d-8568-421b-a495-8fee863c9757 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. c9b584d9-7407-445a-b084-926250af9f8e 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 4aa6eec8-394a-4ecb-8173-66561fd64913 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 25c99ae3-90f4-4a63-924d-f810b3ba6e60 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6 2025-01-03 Warnings Exact identifier application number: M022 Prevention Oncology Mouth Rinse GLYCERIN Prevention Health Sciences, Inc. 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c 2025-01-01 Warnings Exact identifier application number: M022 Prevention Mouth Sore Rinse HYDROGEN PEROXIDE Prevention Health Sciences, Inc. 2eae61e4-1800-5fa6-e063-6394a90a9583 2025-01-01 Warnings Exact identifier application number: M022 Antiseptic Lil Drug Store Products EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Lil' Drug Store Products, Inc dca36a30-2c9f-4d0b-be88-b45c7046f509 2024-12-31 Warnings Exact identifier application number: M022 Sensodyne Clinical White Intensive Clean POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC f193ec40-032f-42c7-81f1-029ec8989374 2024-12-31 Warnings Exact identifier application number: M022 TeethWhitening Kit TEETHWHITENING KIT Jiangxi Dentalbright Technology Co., Ltd. 29393313-217a-dc3a-e063-6294a90addb1 2024-12-20 Warnings Exact identifier application number: M022 Breezers Cool Berry PECTIN Mondelez Global LLC b31d0078-21d7-4d18-a8d3-7c8d48d6d004 2024-12-20 Warnings Exact identifier application number: M022 Breezers Creamy Strawberry PECTIN Mondelez Global LLC 777fd6db-f129-4489-8312-4b1aca94878e 2024-12-20 Warnings Exact identifier application number: M022 Halls Breezers Sugar Free Cool Berry PECTIN Mondelez Global LLC dd1b4b17-4f73-4052-9589-d5fd6bb059bb 2024-12-20 Warnings Exact identifier application number: M022 Oral Gel Oral Pain Relief BENZOCAINE BENZALKONIUM CHLORIDE Savvy Care and Cosmetics 05ede7e4-5a0a-c942-e063-6294a90a8a24 2024-12-19 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint SODIUM BICARBONATE Lotus Brands, Inc. 4a95c8c1-db7c-4791-ac58-3eac216a0126 2024-12-18 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon SODIUM BICARBONATE Lotus Brands, Inc. 6703b29d-cdc9-4c74-91c0-fb0c98dd043e 2024-12-18 Warnings Exact identifier application number: M022 Red Cross Oral Pain Relief BENZOCAINE The Mentholatum Company cbd41429-f730-4577-9f06-ef1831cf62e1 2024-12-17 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10129-033-05 10129003305 6 GEL in 1 BOTTLE, PLASTIC (10129-033-05) 6 gel 1993-07-06 0000-00-00 No No Current