FDA.reportPublic FDA data

Lidocaine 4 Percent

Product NDC
71436-3104
11-digit product format
714363104
Labeler code
71436
Product ID
71436-3104_a0cd961e-c7c7-446b-8ed6-41f6b9fa4a8a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
ARI BRANDS, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
LIDOCAINE
Active strength
4 g/100g
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 Percent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

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
a6451b7d-20b9-46f5-84b3-5430cfe18219Available 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
71436-3104-1Lidocaine 4 Percent1 g in 1 PATCHPATCH13
71436-3104-1Lidocaine 4 Percent10 in 1 BOXPATCH103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71436-3104-1EA - Each71436-3104d0d5d465-8b17-4742-8ed4-07622cb3c3d012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71436-3104LIDOCAINE 4 PERCENT (LIDOCAINE) PATCH [ARI BRANDS, LLC]3Current NDC, 2 package rows20241208_a6451b7d-20b9-46f5-84b3-5430cfe18219.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4 PercentLIDOCAINEARI BRANDS, LLCa6451b7d-20b9-46f5-84b3-5430cfe182192024-12-09WarningsExact identifier
ndc (product): 71436-3104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNa6451b7d-20b9-46f5-84b3-5430cfe182193
1737778lidocaine 0.04 MG/MG Medicated PatchSCDa6451b7d-20b9-46f5-84b3-5430cfe182193
1737778lidocaine 4 % Medicated PatchSYa6451b7d-20b9-46f5-84b3-5430cfe182193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71436-3104-17143631040110 PATCH in 1 BOX (71436-3104-1) / 1 g in 1 PATCH10 patch2023-10-01NoNoCurrent