FDA.reportPublic FDA data

Lidocaine

Product NDC
50488-2004
11-digit product format
504882004
Labeler code
50488
Product ID
50488-2004_c0947407-7431-413a-9278-2df9e92c0e91
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Alexso, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-15
Substance
LIDOCAINE
Active strength
4 g/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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c4e41113-7bf1-4fe9-b460-73e7b839c7a2Available 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
50488-2004-1Lidocaine10 in 1 CARTONPATCH104
50488-2004-1Lidocaine100 g in 1 PATCHPATCH1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-2004-1EA - Each50488-2004c2dbb3e1-6499-46ad-b491-fe8ee052306212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-2004LIDOCAINE PATCH [ALEXSO, INC]4Current NDC, Legacy NDC, 2 package rows20241208_c4e41113-7bf1-4fe9-b460-73e7b839c7a2.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
LidocaineLIDOCAINEAlexso, Incc4e41113-7bf1-4fe9-b460-73e7b839c7a22024-12-09WarningsExact identifier
ndc (product): 50488-2004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-2004-15048820040110 PATCH in 1 CARTON (50488-2004-1) / 100 g in 1 PATCH10 patch2020-01-150000-00-00NoNoCurrent