FDA.reportPublic FDA data

Lidorex

Product NDC
59088-475
11-digit product format
590880475
Labeler code
59088
Product ID
59088-475_f2051c68-cdd9-58b2-e053-2995a90a6b48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-10-25
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
28 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
Lidorex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE28 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
2562183Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc9eeba3-695d-d14e-e053-2a95a90a5c03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-475-07Lidorex100 g in 1 TUBEGEL1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-475-07GM - Gram59088-4753fe679f3-8bbf-4eab-8b39-50c386cd9ad312021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-475LIDOREX (LIDOCAINE HCL) GEL [PURETEK CORPORATION]3Current NDC, Legacy NDC, 1 package rows20230112_cc9eeba3-695d-d14e-e053-2a95a90a5c03.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
LidorexLIDOCAINE HCLPureTek Corporationcc9eeba3-695d-d14e-e053-2a95a90a5c032023-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 59088-475

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2562183lidocaine HCl 2.8 % Topical GelPSNcc9eeba3-695d-d14e-e053-2a95a90a5c033
2562183lidocaine hydrochloride 0.028 MG/MG Topical GelSCDcc9eeba3-695d-d14e-e053-2a95a90a5c033
2562183lidocaine hydrochloride 2.8 % Topical GelSYcc9eeba3-695d-d14e-e053-2a95a90a5c033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-475-0759088047507100 g in 1 TUBE (59088-475-07) 100 g2021-10-250000-00-00NoNoCurrent