Home NDC 10129-072 UltraCare Anesthetic Gel
Product NDC 10129-072
11-digit product format 101290072
Labeler code 10129
Product ID 10129-072_2ce05104-05bd-3ff9-e063-6394a90a51b9
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL; PERIODONTAL; TOPICAL
Labeler The Belport Company, Inc. DBA Gingi-Pak
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-20
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 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10129-072-01 UltraCare Anesthetic Gel 30 g in 1 BOTTLE, PLASTIC GEL 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10129-072 ULTRACARE ANESTHETIC GEL (BENZOCAINE) GEL [THE BELPORT COMPANY, INC. DBA GINGI-PAK] 1 Current NDC, 1 package rows 20240328_142062ca-6f8f-78d2-e063-6294a90a19d8.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 9 of 41 · 818 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10129-072-01 10129007201 30 g in 1 BOTTLE, PLASTIC (10129-072-01) 30 g 2024-03-20 No No Current