FDA.reportPublic FDA data

LIDOCAINE PATCHS

Product NDC
81484-301
Requested package NDC
81484-301-02
11-digit product format
814840301
Labeler code
81484
Product ID
81484-301_cfba7982-c2ed-8e52-e053-2995a90a8ecd
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE 4% MENTHOL 1%
Dosage form
PATCH
Route
TOPICAL
Labeler
Anhui Miao De Tang Pharmaceutical Co., Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-11-01
Marketing end
0000-00-00
Substance
MENTHOL; LIDOCAINE
Active strength
0 g/1; 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 packagepackage81484-30181484-301-02IInactivated 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 · 11 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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81484-301-022024-07-30C16284748780-11e7a6dab-1d59-a2ce-e063-dadaa90aadf7Lidocaine Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81484-301-01Lidocaine Patch1 in 1 BAGPATCH14
81484-301-02Lidocaine Patch6 in 1 BOXPATCH64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81484-301LIDOCAINE PATCH (LIDOCAINE 4% MENTHOL 1%) PATCH [ANHUI MIAO DE TANG PHARMACEUTICAL CO., LTD.]4Legacy NDC, 2 package rows20231115_cfba14e4-a834-a071-e053-2a95a90a658f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNcfba14e4-a834-a071-e053-2a95a90a658f4
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDcfba14e4-a834-a071-e053-2a95a90a658f4
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYcfba14e4-a834-a071-e053-2a95a90a658f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81484-301-02814840301026 BAG in 1 BOX (81484-301-02) > 1 PATCH in 1 BAG (81484-301-01) 6 bag2021-11-010000-00-00NoNoCurrent