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 NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 71085-075 71085-075-60 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warning Warnings for External Use only Avoid contact with eyes Do not use in large quantities, particularly over raw surface or blistered area Stop Use and Ask a Doctor if condition worsens or if symptoms persist for more than 7 days or occur again within a few days. Keep out of reach of children .If swallowed, get medical help or contact a Poison Control Center right away.
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 Identifiers# Field, Values table Field Values Unii 98PI200987 Rxcui 1421893
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
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