Bactoshield CHG

Product NDC
0116-0038
11-digit product format
001160038
Labeler code
0116
Product ID
0116-0038_4576f3ad-5cc9-b4e3-e063-6294a90ace1e
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
NDA019422
Marketing category
NDA
Marketing start
2022-11-16
Marketing end
2027-01-31
Substance
CHLORHEXIDINE GLUCONATE
Active strength
2 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
Bactoshield CHG

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE2 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E

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
0116-0038-03Bactoshield CHG118 mL in 1 BOTTLESOLUTION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0038BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20250503_edfd2be7-b14b-7bd1-e053-2a95a90aa668.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0038-0300116003803118 mL in 1 BOTTLE (0116-0038-03) 118 ml2022-11-162027-01-31NoNoCurrent