FDA.reportPublic FDA data

DermacinRx PHN Pak

Product NDC
59088-807
Requested package NDC
59088-807-00
11-digit product format
590880807
Labeler code
59088
Product ID
59088-807_28a2283a-5bcf-7466-e063-6394a90af78a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-05-17
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59088-80759088-807-00YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59088-80759088-807-00YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59088-80759088-807-00YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
DermacinRx PHN Pak
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d97cb4b-ca51-49a0-b80e-701c1ca6f438Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59088-807-002020-03-05C16284748780-19d75b9d0-4864-f424-e053-dadaa90a57ceDermacinRx® PHN Pak™ Rx Only These highlights do not include all the information needed to use Lidocaine patch 5% safely and effectively. See full prescribing information for Lidocaine patch 5%.
59088-807-002020-01-31C16284748780-19d75b9d0-4864-f424-e053-dadaa90a57ceDermacinRx® PHN Pak™ Rx Only These highlights do not include all the information needed to use Lidocaine patch 5% safely and effectively. See full prescribing information for Lidocaine patch 5%.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-396-82DermacinRx PHN Pak15 in 1 CARTONPATCH50 mg in 1g11
59088-396-82DermacinRx PHN Pak0.7 g in 1 POUCHPATCH0.7 g50 mg in 1g11
59088-807-00DermacinRx PHN Pak1 in 1 KITKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-807-00EA - Each59088-807c07aec27-fed4-461d-8387-e880cbb9eb1812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-807DERMACINRX PHN PAK (LIDOCAINE) KIT [PURETEK CORPORATION]11Current NDC, Legacy NDC, 3 package rows20241208_8d97cb4b-ca51-49a0-b80e-701c1ca6f438.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
DermacinRx PHN PakLIDOCAINEPureTek Corporation8d97cb4b-ca51-49a0-b80e-701c1ca6f4382024-12-06Warnings, Adverse reactionsExact identifier
ndc (package): 59088-807-00
ndc (product): 59088-807
ndc11 (package): 59088080700

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN8d97cb4b-ca51-49a0-b80e-701c1ca6f43811
1745091lidocaine 0.05 MG/MG Medicated PatchSCD8d97cb4b-ca51-49a0-b80e-701c1ca6f43811
1745091lidocaine 5 % Medicated PatchSY8d97cb4b-ca51-49a0-b80e-701c1ca6f43811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-807-00590880807001 KIT in 1 KIT (59088-807-00) * 15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH1 kit2016-05-170000-00-00NoNoCurrent