FDA.reportPublic FDA data

Xyliderm

Product NDC
59088-731
Requested package NDC
59088-731-00
11-digit product format
590880731
Labeler code
59088
Product ID
59088-731_292ffe3d-5894-5477-e063-6294a90a708a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine, Isopropyl Alcohol
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-05
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
Xyliderm
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
1745091Internal RxNorm lookup
2642344Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fed45e06-cc4d-fbc5-e053-6294a90a1b19Available 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
53329-805-60Xyliderm200 in 1 BOXSWAB70 mL in 100mL5
53329-805-60Xyliderm1 in 1 PACKETSWAB70 mL in 100mL5
59088-731-00Xyliderm1 in 1 KITKIT15
59088-905-54Xyliderm30 in 1 PACKAGEPATCH700 mg5
59088-905-84Xyliderm1 in 1 POUCHPATCH1700 mg5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-731-00EA - Each59088-731ef629f35-8526-42e1-9974-1da54015696f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-731XYLIDERM (LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]5Current NDC, 5 package rows20241215_fed45e06-cc4d-fbc5-e053-6294a90a1b19.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
XylidermLIDOCAINE, ISOPROPYL ALCOHOLPureTek Corporationfed45e06-cc4d-fbc5-e053-6294a90a1b192024-12-13Warnings, Adverse reactionsExact identifier
ndc (package): 59088-731-00
ndc (product): 59088-731
ndc11 (package): 59088073100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 5 % Medicated PatchPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBDfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Medicated PadSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Topical ClothSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Topical SwabSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 0.05 MG/MG Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 5 % Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-731-00590880731001 KIT in 1 KIT (59088-731-00) * 30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) * 200 PACKET in 1 BOX (53329-805-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR1 kit2023-07-05NoNoCurrent