FDA.reportPublic FDA data

Lidonex

Product NDC
73564-800
11-digit product format
735640800
Labeler code
73564
Product ID
73564-800_ea39c771-5a73-30d7-e053-2995a90a5118
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hcl
Dosage form
LIQUID
Route
TOPICAL
Labeler
Newpharma, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-10-04
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73564-800IInactivated by FDA2026-10-05
excluded packagepackage73564-80073564-800-02IInactivated by FDA2026-10-05

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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73564-800-022024-03-01C16284748780-11030e365-2d96-111a-e063-dadaa90a10e2ea39cd13-cacf-3d69-e053-2995a90a7906
73564-800-022024-01-30C16284748780-11030e365-2d96-111a-e063-dadaa90a10e2ea39cd13-cacf-3d69-e053-2995a90a7906

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73564-800-02Lidonex60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73564-800LIDONEX (LIDOCAINE HCL) LIQUID [NEWPHARMA, INC.]2Legacy NDC, 1 package rows20240302_ea39cd13-cacf-3d69-e053-2995a90a7906.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSNea39cd13-cacf-3d69-e053-2995a90a79062
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCDea39cd13-cacf-3d69-e053-2995a90a79062
1987647lidocaine hydrochloride 4 % Topical SolutionSYea39cd13-cacf-3d69-e053-2995a90a79062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73564-800-027356408000260 mL in 1 BOTTLE (73564-800-02) 60 ml2022-10-040000-00-00NoNoCurrent