Home NDC 10129-071-01 UltraCare Anesthetic Gel
Product NDC 10129-071
Requested package NDC 10129-071-01
11-digit product format 101290071
Labeler code 10129
Product ID 10129-071_552ed026-466f-4311-e063-6394a90ad1b6
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL; PERIODONTAL; TOPICAL
Labeler The Bellport Company, Inc. dba Gingi-Pak
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-08
Substance BENZOCAINE
Active strength 200 mg/g
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10129-071 10129-071-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10129-071 10129-071-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 UltraCare Anesthetic Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238910 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10129-071-01 UltraCare Anesthetic Gel 30 g in 1 BOTTLE GEL 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10129-071 ULTRACARE ANESTHETIC GEL (BENZOCAINE) GEL [THE BELLPORT COMPANY, INC. DBA GINGI-PAK] 2 Current NDC, 1 package rows 20250130_f5dd8fa8-0b6a-5a30-e053-2995a90ad194.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 34 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Orajel 2X Medicated Gel ORAL PAIN RELIEVER Church & Dwight Co., Inc. 262be295-4eaf-3136-e063-6294a90a7dcc 2024-11-05 Warnings Exact identifier application number: M022 BIOTENE Fresh Mint Original SODIUM FLUORIDE Haleon US Holdings LLC 1101c17f-c848-4cd5-a7cd-679b59dbe1bf 2024-11-05 Warnings Exact identifier application number: M022 biotene SODIUM MONOFLUOROPHOSPHATE Haleon US Holdings LLC a47a6502-efb2-4072-9562-cbe293531c2b 2024-11-04 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Cherry SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited a0e145c8-6b08-40be-ae4f-5678c4a78b1e 2024-10-30 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33b-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33a-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043a3cb4-f560-0ffd-e063-6394a90a2ff6 2024-10-29 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Mint SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited be57ca56-834f-4170-a407-f193484d8b0a 2024-10-29 Warnings Exact identifier application number: M022 SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint SODIUM FLUORIDE Haleon US Holdings LLC 817c0dad-d109-428e-adb5-3354604acc94 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 1f3d68f6-afd6-42e7-b3e5-210228c8e7de 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals LLC 0dd15227-6603-42ac-9a5f-f2dc49e0382a 2024-10-28 Warnings, Adverse reactions Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 0605d5d6-82bd-415e-b5cb-e273f934a4a7 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC f70fa3fc-cd65-4a80-9efd-129e98fd3998 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Menthol PHENOL Chain Drug Consortium af661ef0-cdc3-4146-8ae5-59795aa49650 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry Flavor PHENOL Chain Drug Consortium a9cf9829-4b70-44fa-9719-240b65c06724 2024-10-28 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE PHARMACY VALUE ALLIANCE, LLC 85ae80c1-2bc2-4c90-9559-63510d03e739 2024-10-28 Warnings Exact identifier application number: M022 Chloraspetic MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. 2b1808b2-2574-4ab8-a762-5733251848ce 2024-10-25 Warnings Exact identifier application number: M022 Chloraseptic Warming Sore Throat PHENOL Prestige Brands Holdings, Inc. a197fab2-70ce-4a6c-9add-29d7368a75c5 2024-10-25 Warnings Exact identifier application number: M022 Gly-Oxide CARBAMIDE PEROXIDE Medtech Products Inc. 086a0b82-e947-41c9-89e7-ba06483960c9 2024-10-25 Warnings Exact identifier application number: M022 CHLORASEPTIC MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. d500f423-b9f2-4d98-8f2a-8bab7c05737c 2024-10-25 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 Sample Exclude flag Status 10129-071-01 10129007101 30 g in 1 BOTTLE (10129-071-01) 30 g 2023-02-08 No No Current