Antiseptic Skin Cleanser

Product NDC
0116-3678
11-digit product format
001163678
Labeler code
0116
Product ID
0116-3678_459bd1c9-d7a4-8bc9-e063-6394a90a8ecd
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
2013-01-01
Marketing end
2026-11-30
Substance
CHLORHEXIDINE GLUCONATE
Active strength
4 mg/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic Skin Cleanser

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE4 mg/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
0116-3678-07Antiseptic Skin Cleanser473 mL in 1 BOTTLELIQUID4739
0116-3678-08Antiseptic Skin Cleanser237 mL in 1 BOTTLE, PLASTICLIQUID2379

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-3678ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE 4%) LIQUID [XTTRIUM LABORATORIES, INC.]8Current NDC, Legacy NDC, 2 package rows20250503_4aa41583-790c-2446-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN4aa41583-790c-2446-e054-00144ff8d46c9
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD4aa41583-790c-2446-e054-00144ff8d46c9
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY4aa41583-790c-2446-e054-00144ff8d46c9
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY4aa41583-790c-2446-e054-00144ff8d46c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-3678-0700116367807473 mL in 1 BOTTLE (0116-3678-07) 473 ml2019-01-012026-11-30NoNoCurrent
0116-3678-0800116367808237 mL in 1 BOTTLE, PLASTIC (0116-3678-08) 237 ml2013-01-012026-11-30NoNoCurrent