FDA.reportPublic FDA data

Lidotral 5% Gel

Product NDC
59088-204
Requested package NDC
59088-204-07
11-digit product format
590880204
Labeler code
59088
Product ID
59088-204_1e183af7-73d7-ff32-e063-6294a90a305b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
Puretek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-07-25
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
50 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

Additional Listing Data#

Finished product
Yes
Brand name base
Lidotral 5% Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010057Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e183af7-73d7-ff32-e063-6294a90a305bAvailable 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
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
59088-204-07Lidotral 5% Gel85 g in 1 TUBEGEL851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-204-07GM - Gram59088-204ff541e87-813c-424d-a5fd-147da0150aca12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-204LIDOTRAL 5% GEL (LIDOCAINE HCL) GEL [PURETEK CORPORATION]1Current NDC, 1 package rows20240727_1e183af7-73d7-ff32-e063-6294a90a305b.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
Lidotral 5% GelLIDOCAINE HCLPuretek Corporation1e183af7-73d7-ff32-e063-6294a90a305b2024-07-25Warnings, Adverse reactionsExact identifier
ndc (package): 59088-204-07
ndc (product): 59088-204
ndc11 (package): 59088020407

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010057lidocaine HCl 5 % Topical GelPSN1e183af7-73d7-ff32-e063-6294a90a305b1
1010057lidocaine hydrochloride 0.05 MG/MG Topical GelSCD1e183af7-73d7-ff32-e063-6294a90a305b1
1010057lidocaine hydrochloride 5 % Topical GelSY1e183af7-73d7-ff32-e063-6294a90a305b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-204-075908802040785 g in 1 TUBE (59088-204-07) 85 g2024-07-25NoNoCurrent