Home NDC 10135-672 Lidocaine
Product NDC 10135-672
11-digit product format 101350672
Labeler code 10135
Product ID 10135-672_4391728b-dfe1-3ffb-e063-6394a90a240e
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form CREAM
Route TOPICAL
Labeler Marlex Pharmaceuticals Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-01
Substance LIDOCAINE
Active strength 40 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 Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1421893 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 10135-672-96 Lidocaine 1 in 1 CARTON CREAM 1 7 10135-672-96 Lidocaine 15 g in 1 TUBE CREAM 15 7 10135-672-99 Lidocaine 30 g in 1 TUBE CREAM 30 7 10135-672-99 Lidocaine 1 in 1 CARTON CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-672 LIDOCAINE CREAM [MARLEX PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 4 package rows 20241010_4de2bc60-dc4a-4417-984f-eabab0e926a6.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 Units Marketing start Marketing end Sample Exclude flag Status 10135-672-96 10135067296 1 TUBE in 1 CARTON (10135-672-96) / 15 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current 10135-672-99 10135067299 1 TUBE in 1 CARTON (10135-672-99) / 30 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current