Home NDC 59088-234 Bruselix Cream
Product NDC 59088-234
11-digit product format 590880234
Labeler code 59088
Product ID 59088-234_155cde19-44b5-545a-e063-6294a90aeaeb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine HCI 3.88%
Dosage form CREAM
Route TOPICAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-04-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 38.8 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 Bruselix Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 38.8 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1723991 Internal RxNorm lookup 2678114 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 59088-234-05 Bruselix Cream 57 g in 1 TUBE CREAM 57 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-234 BRUSELIX CREAM (LIDOCAINE HCI 3.88%) CREAM [PURETEK CORPORATION] 2 Current NDC, 1 package rows 20240406_1510163f-b7fd-2e17-e063-6394a90a1799.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 1 of 1 · 1 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 59088-234-05 59088023405 57 g in 1 TUBE (59088-234-05) 57 g 2024-04-01 No No Current