NDC 0116-0228

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4%

Antiseptic Skin Cleanser is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is Chlorhexidine Gluconate.

Product ID0116-0228_7599b112-ed7f-17e0-e053-2991aa0adfdc
NDC0116-0228
Product TypeHuman Otc Drug
Proprietary NameAntiseptic Skin Cleanser
Generic NameChlorhexidine Gluconate 4%
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2012-10-30
Marketing CategoryNDA / NDA
Application NumberNDA019125
Labeler NameXttrium Laboratories, Inc.
Substance NameCHLORHEXIDINE GLUCONATE
Active Ingredient Strength4 mg/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0116-0228-00

237 mL in 1 BOTTLE, PLASTIC (0116-0228-00)
Marketing Start Date2012-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0116-0228-16 [00116022816]

Antiseptic Skin Cleanser LIQUID
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 0116-0228-00 [00116022800]

Antiseptic Skin Cleanser LIQUID
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-30

Drug Details

Active Ingredients

IngredientStrength
CHLORHEXIDINE GLUCONATE4 mg/100mL

OpenFDA Data

SPL SET ID:4ab2dd27-c584-0e49-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211365
  • NDC Crossover Matching brand name "Antiseptic Skin Cleanser" or generic name "Chlorhexidine Gluconate 4%"

    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%
    0116-1061ANTISEPTIC SKIN CLEANSERChlorhexidine Gluconate
    0116-2800Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE
    0116-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0363-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    0404-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    11822-0116Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    11822-0891Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    11822-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    36800-401Antiseptic Skin CleanserChlorhexidine Gluconate 4%
    68016-228Antiseptic Skin CleanserAntiseptic Skin Cleanser
    68599-5401Antiseptic Skin CleanserAntiseptic Skin Cleanser
    70000-0407Antiseptic 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
    62011-0237Antiseptic Skin CleanserAntiseptic Skin Cleanser
    63868-940Antiseptic Skin CleanserAntiseptic Skin Cleanser
    46122-659Antiseptic Skin CleanserAntiseptic Skin Cleanser
    11701-172Antiseptic SolutionChlorhexidine Gluconate 4%
    0116-0039Bactoshield CHGChlorhexidine Gluconate 4%
    0116-0061Cardinal HealthCHLORHEXIDINE GLUCONATE 4%
    0116-1610Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.