Home NDC 82895-717 Westlake Lidocaine
Product NDC 82895-717
11-digit product format 828950717
Labeler code 82895
Product ID 82895-717_45104890-d7b7-5d3d-e063-6394a90ad546
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCL
Dosage form CREAM
Route TOPICAL
Labeler Westlake Pharma LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100g
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 Westlake Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010895 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 82895-717-50 Westlake Lidocaine 1 in 1 CARTON CREAM 1 2 82895-717-50 Westlake Lidocaine 49 g in 1 BOTTLE, PLASTIC CREAM 49 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82895-717 WESTLAKE LIDOCAINE (LIDOCAINE HCL) CREAM [WESTLAKE PHARMA LLC] 1 Current NDC, 2 package rows 20231213_0c586a14-1a2a-9f42-e063-6294a90a16c1.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82895-717-50 82895071750 1 BOTTLE, PLASTIC in 1 CARTON (82895-717-50) / 49 g in 1 BOTTLE, PLASTIC 2023-10-01 No No Current