CliniClean

Product NDC
0116-0901
11-digit product format
001160901
Labeler code
0116
Product ID
0116-0901_50769b8c-0d03-be16-e063-6294a90a01d6
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE 4%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
NDA019125
Marketing category
NDA
Marketing start
2023-03-23
Substance
CHLORHEXIDINE GLUCONATE
Active strength
4 g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CliniClean
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui211365

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-0901-08CliniClean237 mL in 1 BOTTLESOLUTION2376
0116-0901-16CliniClean473 mL in 1 BOTTLESOLUTION4736
0116-0901-32CliniClean946 mL in 1 BOTTLESOLUTION9466

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0901CLINICLEAN (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Current NDC, 3 package rows20250503_f8352f15-b481-ee95-e053-6294a90ac535.zip
0116-0901CLINICLEAN (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Current NDC20250503_f8346bd2-72af-e396-e053-6294a90ab602.zip
0116-0901CLINICLEAN (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]2Current NDC20250503_f8354044-6b99-6d2c-e053-6294a90a74b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSNf8352f15-b481-ee95-e053-6294a90ac5356
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCDf8352f15-b481-ee95-e053-6294a90ac5356
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSYf8352f15-b481-ee95-e053-6294a90ac5356
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSYf8352f15-b481-ee95-e053-6294a90ac5356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0116-0901-0800116090108237 mL in 1 BOTTLE237 mlHistorical
0116-0901-1600116090116473 mL in 1 BOTTLE473 mlHistorical
0116-0901-3200116090132946 mL in 1 BOTTLE (0116-0901-32) 946 ml2023-03-23NoNoHistorical