FDA.reportPublic FDA data

Lidocaine

Product NDC
71399-6544
Requested package NDC
71399-6544-1
11-digit product format
713996544
Labeler code
71399
Product ID
71399-6544_d22c8c01-1ba3-e9d3-e053-2995a90ac4f0
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-11-01
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
4 g/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage71399-654471399-6544-1IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-6544-12023-04-03C16284748780-1f386c649-cf3d-0266-e053-dadaa90a7c1aAsperFlex (Lidocaine 4% Ointment)
71399-6544-12023-01-30C16284748780-1f386c649-cf3d-0266-e053-dadaa90a7c1aAsperFlex (Lidocaine 4% Ointment)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-6544-1Lidocaine1 in 1 JAROINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-6544-1GM - Gram71399-6544f9834224-8643-4fd6-8c79-37907298aa8312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-6544LIDOCAINE OINTMENT [AKRON PHARMA INC.]3Legacy NDC, 1 package rows20240922_d22c8c01-1ba2-e9d3-e053-2995a90ac4f0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-6544-1713996544011 OINTMENT in 1 JAR (71399-6544-1) 1 ointment2021-11-010000-00-00NoNoCurrent