NDC 0116-6720

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Chlorhexidine Gluconate 0.12% Oral Rinse

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is Chlorhexidine Gluconate.

Product ID0116-6720_6eed67a9-56ec-37e2-e053-2a91aa0a915f
NDC0116-6720
Product TypeHuman Prescription Drug
Proprietary NameAcclean Chlorhexidine Gluconate 0.12% Oral Rinse
Generic NameChlorhexidine Gluconate 0.12% Oral Rinse
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA077789
Labeler NameXttrium Laboratories, Inc.
Substance NameCHLORHEXIDINE GLUCONATE
Active Ingredient Strength1 mg/mL
Pharm ClassesDecreased Cell Wall Integrity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0116-6720-04

118 mL in 1 BOTTLE (0116-6720-04)
Marketing Start Date2016-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0116-6720-04 [00116672004]

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse LIQUID
Marketing CategoryANDA
Application NumberANDA077789
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-22

Drug Details

Active Ingredients

IngredientStrength
CHLORHEXIDINE GLUCONATE1.2 mg/mL

OpenFDA Data

SPL SET ID:4a2a6bb8-85b0-6c36-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 834127
  • Pharmacological Class

    • Decreased Cell Wall Integrity [PE]

    NDC Crossover Matching brand name "Acclean Chlorhexidine Gluconate 0.12% Oral Rinse" or generic name "Chlorhexidine Gluconate 0.12% Oral Rinse"

    NDCBrand NameGeneric Name
    0116-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse
    0116-6720Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse
    0404-4075Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse
    0404-6720Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse
    55154-1980DASH Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse
    55154-1981DASH Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse
    69339-138DASH Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse

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