Antiseptic Skin Cleanser

Product NDC
0116-0767
11-digit product format
001160767
Labeler code
0116
Product ID
0116-0767_4c21b269-c2e0-8b47-e063-6294a90a37c2
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE 4%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
NDA019125
Marketing category
NDA
Marketing start
2011-08-31
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
Antiseptic Skin Cleanser
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
0116-0767-08Antiseptic Skin Cleanser237 mL in 1 BOTTLELIQUID23712
0116-0767-16Antiseptic Skin Cleanser473 mL in 1 BOTTLELIQUID47312
0116-0767-18Antiseptic Skin Cleanser532 mL in 1 BOTTLE, PUMPLIQUID53212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0767ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE 4%) LIQUID [XTTRIUM LABORATORIES, INC.]10Current NDC, Legacy NDC, 3 package rows20250503_48a814e7-bfe4-5437-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN48a814e7-bfe4-5437-e054-00144ff88e8812
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD48a814e7-bfe4-5437-e054-00144ff88e8812
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY48a814e7-bfe4-5437-e054-00144ff88e8812
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY48a814e7-bfe4-5437-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0767-0800116076708237 mL in 1 BOTTLE (0116-0767-08) 237 ml2011-08-310000-00-00NoNoCurrent
0116-0767-1600116076716473 mL in 1 BOTTLE (0116-0767-16) 473 ml2017-01-010000-00-00NoNoCurrent
0116-0767-1800116076718532 mL in 1 BOTTLE, PUMP (0116-0767-18) 532 ml2022-11-142027-01-31NoNoCurrent