FDA.reportPublic FDA data

Lidocaine 4% Pain Relief Gel Patch

Product NDC
55629-024
11-digit product format
556290024
Labeler code
55629
Product ID
55629-024_ae454939-13c4-453d-a650-7a7f97d5893c
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4% Pain Relief Gel Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
ONE2ZEE LIMITED LIABILITY COMPANY
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-03
Substance
LIDOCAINE
Active strength
40 mg/1
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 4% Pain Relief Gel Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/1

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
8e5a4ef4-b928-44b3-842c-92f1531af75bAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-024-15Lidocaine 4% Pain Relief Gel Patch15 in 1 BOXPATCH151
55629-024-15Lidocaine 4% Pain Relief Gel Patch1 in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-024LIDOCAINE 4% PAIN RELIEF GEL PATCH PATCH [ONE2ZEE LIMITED LIABILITY COMPANY]1Current NDC, 2 package rows20250306_8e5a4ef4-b928-44b3-842c-92f1531af75b.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 6 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN8e5a4ef4-b928-44b3-842c-92f1531af75b1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD8e5a4ef4-b928-44b3-842c-92f1531af75b1
1737778lidocaine 4 % Medicated PatchSY8e5a4ef4-b928-44b3-842c-92f1531af75b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55629-024-155562900241515 POUCH in 1 BOX (55629-024-15) / 1 PATCH in 1 POUCH15 pouch2025-03-03NoNoCurrent