FDA.reportPublic FDA data

Bactoshield CHG

Product NDC
11084-128
11-digit product format
110840128
Labeler code
11084
Product ID
11084-128_8bc40612-5f9c-4de9-b3e7-42fe12678853
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
SC Johnson Professional USA, Inc.
Application
NDA019258
Marketing category
NDA
Marketing start
2019-08-15
Substance
CHLORHEXIDINE GLUCONATE
Active strength
40 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bactoshield CHG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui211365, 2186092

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-128-03Bactoshield CHG118 mL in 1 BOTTLELIQUID1183
11084-128-08Bactoshield CHG3785 mL in 1 BOTTLELIQUID37853
11084-128-24Bactoshield CHG946 mL in 1 BOTTLELIQUID9463
11084-128-34Bactoshield CHG473 mL in 1 BOTTLELIQUID4733

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2186092Bactoshield 4 % Medicated Liquid SoapPSN5d49522f-63e5-4297-adf5-b5f3bd419d473
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN5d49522f-63e5-4297-adf5-b5f3bd419d473
2186092chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Bactoshield]SBD5d49522f-63e5-4297-adf5-b5f3bd419d473
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD5d49522f-63e5-4297-adf5-b5f3bd419d473
2186092Bactoshield 4 % Medicated Liquid SoapSY5d49522f-63e5-4297-adf5-b5f3bd419d473
2186092Bactoshield 40 MG/ML Medicated Liquid SoapSY5d49522f-63e5-4297-adf5-b5f3bd419d473
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY5d49522f-63e5-4297-adf5-b5f3bd419d473
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY5d49522f-63e5-4297-adf5-b5f3bd419d473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-128-0311084012803118 mL in 1 BOTTLE (11084-128-03) 118 ml2019-08-150000-00-00NoNoCurrent
11084-128-08110840128083785 mL in 1 BOTTLE (11084-128-08) 3785 ml2019-08-150000-00-00NoNoCurrent
11084-128-2411084012824946 mL in 1 BOTTLE (11084-128-24) 946 ml2019-08-150000-00-00NoNoCurrent
11084-128-3411084012834473 mL in 1 BOTTLE (11084-128-34) 473 ml2019-08-150000-00-00NoNoCurrent