FDA.reportPublic FDA data

Lidocaine Patch 4%

Product NDC
82461-416
11-digit product format
824610416
Labeler code
82461
Product ID
82461-416_bf38c2df-2b08-430e-8272-c9975d2e8e38
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Medcore LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-18
Substance
LIDOCAINE
Active strength
40 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Patch 4%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737778Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b961906c-fe66-466b-af2c-072781fa098bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-416-30Lidocaine Patch 4%6 in 1 BOXPATCH61
82461-416-30Lidocaine Patch 4%5 g in 1 POUCHPATCH51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-416-30EA - Each82461-416dda3a8e4-8997-4d5b-9458-cb37466dfb4212025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82461-416LIDOCAINE PATCH 4% (LIDOCAINE 4%) PATCH [MEDCORE LLC]1Current NDC, 2 package rows20250519_b961906c-fe66-466b-af2c-072781fa098b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaayou NumbingDIBUCAINE HYDROCHLORIDE 0.5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4c290118-7880-2a98-e063-6294a90a4c032026-07-21WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a36edc5-5a89-afb5-e063-6294a90a02dd2026-07-21WarningsExact identifier
application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINLIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINJiangxi Yudexi Pharmaceutical Co., LTD4a45c1cb-c5ab-d872-e063-6394a90aab5d2026-07-21WarningsExact identifier
application number: M017
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
application number: M017
DERMFREE MEDICATED LIPCAMPHOR 2.0% MEDICATED LIPJiangxi Yudexi Pharmaceutical Co., LTD4a4d62fb-8dfa-404a-e063-6294a90a385d2026-07-21WarningsExact identifier
application number: M017
NATUHEAL RELIEF Cream FOR ECZEMAHYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD4c92fed1-a8b4-bda8-e063-6394a90a8a332026-07-20WarningsExact identifier
application number: M017
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
application number: M017
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
application number: M017
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
application number: M017
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
application number: M017
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M017
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.4981e9c3-2a19-aed8-e063-6294a90af2162026-07-17WarningsExact identifier
application number: M017
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
application number: M017
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.56d30c33-ef5a-c63d-e063-6294a90acd292026-07-17WarningsExact identifier
application number: M017
Mineral Ice Extreme Gel Alpine Fresh ScentMENTHOLCarlin Consumer Health LLC56d3ca3d-21e1-a40a-e063-6294a90a9ff42026-07-17WarningsExact identifier
application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT PatchMENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56b83ee8-8d86-9436-e063-6294a90a0c252026-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNb961906c-fe66-466b-af2c-072781fa098b1
1737778lidocaine 0.04 MG/MG Medicated PatchSCDb961906c-fe66-466b-af2c-072781fa098b1
1737778lidocaine 4 % Medicated PatchSYb961906c-fe66-466b-af2c-072781fa098b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82461-416-30824610416306 POUCH in 1 BOX (82461-416-30) / 5 g in 1 POUCH6 pouch2025-05-18NoNoCurrent