FDA.reportPublic FDA data

DermacinRx Surgical ComboPak

Product NDC
59088-334
11-digit product format
590880334
Labeler code
59088
Product ID
59088-334_292fb349-6c9d-d1dd-e063-6394a90a5ed9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate Surgical Combo Kit
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-04-28
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
DermacinRx Surgical ComboPak
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
211365Internal RxNorm lookup
259090Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7aff8c66-e758-438a-872d-804a35bb372aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-1061-08DermacinRx Surgical ComboPak237 mL in 1 BOTTLE, PLASTICSOLUTION237 mL4 g in 100mL8
59088-333-08DermacinRx Surgical ComboPak118 mL in 1 TUBECREAM118 mL50 mg in 1mL8
59088-334-00DermacinRx Surgical ComboPak1 in 1 PACKAGEKIT18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8EDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
DimethiconeACTIVE INGREDIENT92RU3N3Y1ODERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
DIMETHICONEACTIVE MOIETY92RU3N3Y1ODERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RADERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
CARTHAMUS TINCTORIUS SEED OLEOSOMESINACTIVE INGREDIENT9S60Q72309DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OKDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
GINGERINACTIVE INGREDIENTC5529G5JPQDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TBDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MSDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
TRIDECYL ALCOHOLINACTIVE INGREDIENT8I9428H868DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RDERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-334DERMACINRX SURGICAL COMBOPAK (CHLORHEXIDINE GLUCONATE SURGICAL COMBO KIT) KIT [PURETEK CORPORATION]8Current NDC, Legacy NDC, 3 package rows20241215_7aff8c66-e758-438a-872d-804a35bb372a.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 Surgical ComboPakCHLORHEXIDINE GLUCONATE SURGICAL COMBO KITPureTek Corporation7aff8c66-e758-438a-872d-804a35bb372a2024-12-13WarningsExact identifier
ndc (product): 59088-334

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN7aff8c66-e758-438a-872d-804a35bb372a8
259090dimethicone 5 % Topical CreamPSN7aff8c66-e758-438a-872d-804a35bb372a8
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD7aff8c66-e758-438a-872d-804a35bb372a8
259090dimethicone 50 MG/ML Topical CreamSCD7aff8c66-e758-438a-872d-804a35bb372a8
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY7aff8c66-e758-438a-872d-804a35bb372a8
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY7aff8c66-e758-438a-872d-804a35bb372a8
259090dimethicone 5 % Topical CreamSY7aff8c66-e758-438a-872d-804a35bb372a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-1061-0800116106108237 mL in 1 BOTTLE, PLASTIC237 mlHistorical
59088-333-0859088033308118 mL in 1 TUBE118 mlHistorical
59088-334-00590880334001 KIT in 1 PACKAGE (59088-334-00) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08) 1 kit2015-04-280000-00-00NoNoCurrent