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 33 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COOL RELIEF LEMON FROST ORAL ANESTHETIC MENTHOL Ricola Ag 908f5ce5-94a4-4c35-ae7a-b308ea37fa08 2024-12-05 Warnings Exact identifier application number: M022 ORGANIC PEPPERMINT HERB THROAT DROPS MENTHOL Ricola Ag a6657ecf-e74a-4912-a68c-73abc456f9e2 2024-12-05 Warnings Exact identifier application number: M022 NATURAL LEMON MINT HERB THROAT DROPS MENTHOL Ricola Ag 67373cf1-e8c3-4db2-98e1-c88d25a76209 2024-12-05 Warnings Exact identifier application number: M022 Natural Cherry Honey Herb Throat Drops MENTHOL Ricola Ag 586b2a46-2673-4f27-a62a-2d48a9b520ab 2024-12-05 Warnings Exact identifier application number: M022 BERRY MEDLEY THROAT DROPS MENTHOL Ricola Ag a2bdd035-4678-4cff-b24f-8e2f06acad96 2024-12-05 Warnings Exact identifier application number: M022 Orajel Toothache Rinse BENZYL ALCOHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 41709710-5392-3119-e054-00144ff88e88 2024-11-27 Warnings Exact identifier application number: M022 Orajel Antiseptic Alcohol-Free Mouth Sore Rinse HYDROGEN PEROXIDE, MENTHOL Church & Dwight Co., Inc. 99d47d6a-fa2e-d5ee-e053-2995a90aa11d 2024-11-27 Warnings Exact identifier application number: M022 Orajel 2x Gum Pain Alcohol-Free MENTHOL AND HYDROGEN PEROXIDE Church & Dwight Co., Inc. adf37010-922c-4441-93d6-1e1a95025e90 2024-11-27 Warnings Exact identifier application number: M022 Maximum Strength Cold Sore Treatment CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM Meijer Distribution Inc 9220772c-b3b7-4855-e053-2a95a90a94f6 2024-11-27 Warnings Exact identifier application number: M022 Peroxyl Mouth Sore Mild Mint HYDROGEN PEROXIDE Colgate Oral Pharmaceuticals Inc. b1e1b7c9-dea7-4d64-b6a8-5343f4176359 2024-11-25 Warnings Exact identifier application number: M022 NICE SORE THROAT Spearmint PHENOL Leosons Overseas Corp 5fc68f04-ec15-11c0-e053-2a91aa0a1952 2024-11-20 Warnings Exact identifier application number: M022 TANAC Oral Pain Reliever BENZOCAINE Leosons Overseas Corp 81cc61fa-31a7-2214-e053-2a91aa0ae46a 2024-11-15 Warnings Exact identifier application number: M022 NICE SORE THROAT Honey Lemon PHENOL Leosons Overseas Corp 601aea98-e6ab-de6f-e053-2a91aa0a824a 2024-11-15 Warnings Exact identifier application number: M022 NICE SORE THROAT Cherry PHENOL Leosons Overseas Corp 5f21694c-d1c9-0e64-e053-2a91aa0a0ff0 2024-11-15 Warnings Exact identifier application number: M022 Sore Throat PHENOL Safeway, Inc. f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d 2024-11-14 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry PHENOL Best Choice (Valu Merchandisers Company) c0a47d59-3e15-453d-97a7-d626e8650862 2024-11-14 Warnings Exact identifier application number: M022 Listerine Gum Therapy Glacier Mint EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Kenvue Brands LLC ed6889b6-58db-41cf-e053-2a95a90a7de2 2024-11-11 Warnings Exact identifier application number: M022 Listerine FreshBurst Antiseptic EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Kenvue Brands LLC 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8 2024-11-11 Warnings Exact identifier application number: M022 Listerine Ultraclean Antiseptic Cool Mint EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Kenvue Brands LLC dd3729c2-fd05-4db0-a542-487bb0f9001f 2024-11-11 Warnings Exact identifier application number: M022 Listerine Cool Mint Antiseptic EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Kenvue Brands LLC 9e97e4f8-80c2-44e0-862c-0dfca392a436 2024-11-11 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