NDC 0116-1061

ANTISEPTIC SKIN CLEANSER

Chlorhexidine Gluconate

ANTISEPTIC SKIN CLEANSER is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is Chlorhexidine Gluconate.

Product ID0116-1061_6e5e678f-3833-d201-e053-2a91aa0a5ea8
NDC0116-1061
Product TypeHuman Otc Drug
Proprietary NameANTISEPTIC SKIN CLEANSER
Generic NameChlorhexidine Gluconate
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2011-08-31
Marketing CategoryNDA / NDA
Application NumberNDA019125
Labeler NameXttrium Laboratories, Inc.
Substance NameCHLORHEXIDINE GLUCONATE
Active Ingredient Strength4 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0116-1061-04

118 mL in 1 BOTTLE, PLASTIC (0116-1061-04)
Marketing Start Date2011-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0116-1061-18 [00116106118]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-31

NDC 0116-1061-16 [00116106116]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-08-31

NDC 0116-1061-08 [00116106108]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-08-31

NDC 0116-1061-04 [00116106104]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-08-31

NDC 0116-1061-01 [00116106101]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-31

NDC 0116-1061-15 [00116106115]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-01

NDC 0116-1061-32 [00116106132]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-08-31

NDC 0116-1061-09 [00116106109]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-31
Marketing End Date2017-11-06

NDC 0116-1061-40 [00116106140]

ANTISEPTIC SKIN CLEANSER SOLUTION
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
CHLORHEXIDINE GLUCONATE4 g/100mL

OpenFDA Data

SPL SET ID:6e62eb50-ebaa-361e-e053-2991aa0aba6f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211365
    • UPC Code
  • 0301161061153

    • NDC Crossover Matching brand name "ANTISEPTIC SKIN CLEANSER" or generic name "Chlorhexidine Gluconate"

    NDCBrand NameGeneric Name
    0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0401Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0116-0407ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATE
    0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%
    68016-228Antiseptic Skin CleanserAntiseptic Skin Cleanser
    68599-5401Antiseptic Skin CleanserAntiseptic Skin Cleanser
    70000-0407Antiseptic Skin CleanserAntiseptic Skin Cleanser
    11822-3678Antiseptic Skin CleanserAntiseptic Skin Cleanser
    0116-1061ANTISEPTIC SKIN CLEANSERANTISEPTIC SKIN CLEANSER
    0116-3678Antiseptic Skin CleanserAntiseptic Skin Cleanser
    36800-401Antiseptic Skin CleanserAntiseptic Skin Cleanser
    37205-595ANTISEPTIC SKIN CLEANSERANTISEPTIC SKIN CLEANSER
    41250-162Antiseptic Skin CleanserAntiseptic Skin Cleanser
    46122-137Antiseptic Skin CleanserAntiseptic Skin Cleanser
    49348-115Antiseptic Skin CleanserAntiseptic Skin Cleanser
    59779-767Antiseptic Skin CleanserAntiseptic Skin Cleanser
    61715-072Antiseptic Skin CleanserAntiseptic Skin Cleanser
    0363-1061Antiseptic Skin CleanserAntiseptic Skin Cleanser
    62011-0237Antiseptic Skin CleanserAntiseptic Skin Cleanser
    63868-940Antiseptic Skin CleanserAntiseptic Skin Cleanser
    0404-1061Antiseptic Skin CleanserAntiseptic Skin Cleanser
    46122-659Antiseptic Skin CleanserAntiseptic Skin Cleanser
    0116-0505BD E-Z Scrubchlorhexidine gluconate
    0116-0506BD E-Z Scrubchlorhexidine gluconate
    0116-0101Chlorhexidine GluconateChlorhexidine Gluconate
    0116-0175Chlorhexidine GluconateChlorhexidine Gluconate
    0116-0301Chlorhexidine GluconateChlorhexidine Gluconate
    0116-0003Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE
    0116-1021DYNA-HEXChlorhexidine gluconate
    0116-0800NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATE
    0116-0620Peridexchlorhexidine gluconate
    0116-0722Scrub CareCHLORHEXIDINE GLUCONATE
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