FDA.reportPublic FDA data

LidoPro Patch

Product NDC
45865-903
Requested package NDC
45865-903-01
11-digit product format
458650903
Labeler code
45865
Product ID
45865-903_7d64c5d3-d8f4-4075-e053-2991aa0aeaa8
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol, and Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
medsource pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-02
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE
Active strength
4 mg/100mg; mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage45865-90345865-903-01IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-903-012025-01-30C16284748780-12cef2736-59a9-d83d-e063-dadaa90ab31fLidoPro Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-903-01LidoPro Patch15 in 1 CARTONPATCH151
45865-903-01LidoPro Patch5 in 1 POUCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-903LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181220_7d64bbdc-f965-5427-e053-2991aa0a463f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchPSN7d64bbdc-f965-5427-e053-2991aa0a463f1
1599302LidoPro Patch 4 % / 5 % / 4 % Medicated PatchPSN7d64bbdc-f965-5427-e053-2991aa0a463f1
1599302lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated Patch [LidoPro Patch]SBD7d64bbdc-f965-5427-e053-2991aa0a463f1
1599164lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated PatchSCD7d64bbdc-f965-5427-e053-2991aa0a463f1
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchSY7d64bbdc-f965-5427-e053-2991aa0a463f1
1599302LidoPro Patch (lidocaine 4 % / menthol 5 % / methyl salicylate 4 % ) Medicated PatchSY7d64bbdc-f965-5427-e053-2991aa0a463f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-903-014586509030115 POUCH in 1 CARTON (45865-903-01) > 5 PATCH in 1 POUCH > 8500 mg in 1 PATCH15 pouch2018-06-010000-00-00NoNoCurrent