Home NDC 71085-075 Lidocaine Cream, 4%
Product NDC 71085-075
11-digit product format 710850075
Labeler code 71085
Product ID 71085-075_4cb1ebaa-d40c-7055-e063-6294a90a4e77
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form CREAM
Route TOPICAL
Labeler IPG PHARMACEUTICALS, INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-13
Substance LIDOCAINE
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 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 Lidocaine Cream, 4%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/100g
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 71085-075-19 Lidocaine Cream, 4% 119 g in 1 BOTTLE, DISPENSING CREAM 119 5 71085-075-58 Lidocaine Cream, 4% 58.5 g in 1 BOTTLE, DISPENSING CREAM 58.5 5 71085-075-60 Lidocaine Cream, 4% 60 g in 1 BOTTLE, DISPENSING CREAM 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71085-075 LIDOCAINE CREAM, 4% (LIDOCAINE) CREAM [IPG PHARMACEUTICALS, INC.] 3 Current NDC, 3 package rows 20250321_7775bfdd-7eac-4f09-b83f-fc4a16a24558.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 Sample Exclude flag Status 71085-075-19 71085007519 119 g in 1 BOTTLE, DISPENSING (71085-075-19) 119 g 2025-03-17 No No Current 71085-075-58 71085007558 58.5 g in 1 BOTTLE, DISPENSING (71085-075-58) 58.5 g 2026-03-10 No No Current 71085-075-60 71085007560 60 g in 1 BOTTLE, DISPENSING 60 g Historical