LIDOCAINE 4%

Product NDC
80425-0542
11-digit product format
804250542
Labeler code
80425
Product ID
80425-0542_3bdd6b35-3725-fce6-e063-6294a90ad528
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine 4%
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Advanced Rx of Tennessee, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-08
Substance
LIDOCAINE
Active strength
400 mg/10g
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
98PI200987LIDOCAINE137-58-6LIDOCAINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0542-18042505420130 PATCH in 1 BOX (80425-0542-1) / 10 g in 1 PATCH30 patch2025-08-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lidocaine 4% Patch #30Advanced Rx of Tennessee, LLC2025-08-08HUMAN OTC DRUG LABEL1