FDA.reportPublic FDA data

DermacinRx PHN Pak

Product NDC
59088-807
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

Additional Listing Data#

Finished product
Yes
Brand name base
DermacinRx PHN Pak
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1745091

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

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
59088-396-825908803968215 in 1 CARTONHistorical
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