FDA.reportPublic FDA data

Lidocaine with Menthol Patch

Product NDC
55629-061
Requested package NDC
55629-061-02
11-digit product format
556290061
Labeler code
55629
Product ID
55629-061_14685a37-dbf3-4e81-8b2e-99a1a07dd8e5
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine 4% and menthol 1%
Dosage form
PATCH
Route
TOPICAL
Labeler
ONE2ZEE LIMITED LIABILITY COMPANY
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-26
Marketing end
0000-00-00
Substance
LIDOCAINE; MENTHOL
Active strength
40 mg/1; mg/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 packagepackage55629-06155629-061-02IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
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
55629-061-022023-01-30C16284748780-1f386c64a-15af-0266-e053-dadaa90a7c1aLIDOCAINE WITH MENTHOL PATCH PAIN RELIEF- lidocaine 4% and menthol 1% patch
55629-061-032023-01-30C16284748780-1f386c649-d26b-0266-e053-dadaa90a7c1aLIDOCAINE WITH MENTHOL PATCH PAIN RELIEF- lidocaine 4% and menthol 1% patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-061-01Lidocaine with Menthol PatchPain Releif1 in 1 POUCHPATCH12
55629-061-03Lidocaine with Menthol PatchPain Releif20 in 1 BOXPATCH202
55629-061-01Lidocaine with Menthol PatchPain Releif1 in 1 POUCHPATCH11
55629-061-02Lidocaine with Menthol PatchPain Releif45 in 1 BOXPATCH451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-061LIDOCAINE WITH MENTHOL PATCH PAIN RELEIF (LIDOCAINE 4% AND MENTHOL 1%) PATCH [ONE2ZEE LIMITED LIABILITY COMPANY]2Legacy NDC, 2 package rows20210704_8cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd9.zip
55629-061LIDOCAINE WITH MENTHOL PATCH PAIN RELEIF (LIDOCAINE 4% AND MENTHOL 1%) PATCH [ONE2ZEE LIMITED LIABILITY COMPANY]1Legacy NDC, 2 package rows20210628_bb989956-3e09-480e-95c2-3c9cef5131a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN8cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd92
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD8cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd92
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY8cc9275c-dfd7-4ba2-8acf-8ae27d2dfdd92
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNbb989956-3e09-480e-95c2-3c9cef5131a41
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDbb989956-3e09-480e-95c2-3c9cef5131a41
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYbb989956-3e09-480e-95c2-3c9cef5131a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55629-061-025562900610245 POUCH in 1 BOX (55629-061-02) > 1 PATCH in 1 POUCH (55629-061-01) 45 pouch2021-01-260000-00-00NoNoCurrent