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

Additional Listing Data#

Finished product
Yes
Brand name base
DermacinRx Surgical ComboPak
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui211365, 259090

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

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