FDA.reportPublic FDA data

DermacinRx ZRM Pak

Product NDC
59088-805
Requested package NDC
59088-805-00
11-digit product format
590880805
Labeler code
59088
Product ID
59088-805_2baebf45-d382-1bfe-e063-6394a90aa37f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine, dimethicone
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-05-12
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 packagepackage59088-80559088-805-00YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59088-80559088-805-00YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59088-80559088-805-00YUnknown 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 ZRM Pak
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259090Internal RxNorm lookup
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
57c4672d-37b1-4af3-a9fc-d8390016338dAvailable 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
59088-805-002020-02-06C16284748780-19d75b9d1-23ac-f424-e053-dadaa90a57ceDermacinRx ® ZRM Pak™ Rx Only
59088-805-002020-01-31C16284748780-19d75b9d1-23ac-f424-e053-dadaa90a57ceDermacinRx ® ZRM Pak™ Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-333-08DermacinRx ZRM Pak118 mL in 1 TUBECREAM118 mL50 mg in 1mL11
59088-396-82DermacinRx ZRM Pak0.7 g in 1 POUCHPATCH0.7 g50 mg in 1g11
59088-396-82DermacinRx ZRM Pak15 in 1 CARTONPATCH50 mg in 1g11
59088-805-00DermacinRx ZRM Pak1 in 1 KITKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-805-00EA - Each59088-805495cef1c-5215-4e4e-b67b-d595cda1e0a312016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-805DERMACINRX ZRM PAK (LIDOCAINE, DIMETHICONE) KIT [PURETEK CORPORATION]11Current NDC, Legacy NDC, 4 package rows20250116_57c4672d-37b1-4af3-a9fc-d8390016338d.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 ZRM PakLIDOCAINE, DIMETHICONEPureTek Corporation57c4672d-37b1-4af3-a9fc-d8390016338d2025-01-14Warnings, Adverse reactionsExact identifier
ndc (package): 59088-805-00
ndc (product): 59088-805
ndc11 (package): 59088080500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259090dimethicone 5 % Topical CreamPSN57c4672d-37b1-4af3-a9fc-d8390016338d11
1745091lidocaine 5 % Medicated PatchPSN57c4672d-37b1-4af3-a9fc-d8390016338d11
259090dimethicone 50 MG/ML Topical CreamSCD57c4672d-37b1-4af3-a9fc-d8390016338d11
1745091lidocaine 0.05 MG/MG Medicated PatchSCD57c4672d-37b1-4af3-a9fc-d8390016338d11
259090dimethicone 5 % Topical CreamSY57c4672d-37b1-4af3-a9fc-d8390016338d11
1745091lidocaine 5 % Medicated PatchSY57c4672d-37b1-4af3-a9fc-d8390016338d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-805-00590880805001 KIT in 1 KIT (59088-805-00) * 118 mL in 1 TUBE (59088-333-08) * 15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH1 kit2016-05-120000-00-00NoNoCurrent