FDA.reportPublic FDA data

Pain Relief 4% Lidocaine

Product NDC
71391-151
Requested package NDC
71391-151-01
11-digit product format
713910151
Labeler code
71391
Product ID
71391-151_53d32025-8048-4c6e-8b97-963b67e4f1e1
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Unexo Life Sciences Private Limited
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-08-15
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
344 mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71391-15171391-151-01DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71391-15171391-151-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71391-151-01Pain Relief 4% Lidocaine1 in 1 POUCHPATCH12
71391-151-05Pain Relief 4% Lidocaine5 in 1 BOXPATCH52
71391-151-06Pain Relief 4% Lidocaine6 in 1 BOXPATCH62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71391-151PAIN RELIEF 4% LIDOCAINE (LIDOCAINE) PATCH [UNEXO LIFE SCIENCES PRIVATE LIMITED]2Legacy NDC, 3 package rows20250115_bfee9be1-b265-44bd-8e82-2ec27132f82b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNbfee9be1-b265-44bd-8e82-2ec27132f82b2
1737778lidocaine 0.04 MG/MG Medicated PatchSCDbfee9be1-b265-44bd-8e82-2ec27132f82b2
1737778lidocaine 4 % Medicated PatchSYbfee9be1-b265-44bd-8e82-2ec27132f82b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71391-151-01713910151011 PATCH in 1 POUCH (71391-151-01) 1 patch2022-08-150000-00-00NoNoCurrent