FDA.reportPublic FDA data

CHLORHEXIDINE GLUCONATE

Product NDC
16571-111
11-digit product format
165710111
Labeler code
16571
Product ID
16571-111_32cca440-c887-49ab-9c52-0b43fdf87b78
Type
HUMAN OTC DRUG
Nonproprietary name
chlorhexidine gluconate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Rising Pharma Holdings, Inc.
Application
NDA019258
Marketing category
NDA
Marketing start
2023-07-26
Substance
CHLORHEXIDINE GLUCONATE
Active strength
40 mg/mL
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
CHLORHEXIDINE GLUCONATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui211365

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
16571-111-12CHLORHEXIDINE GLUCONATE118 mL in 1 BOTTLESOLUTION1182
16571-111-24CHLORHEXIDINE GLUCONATE237 mL in 1 BOTTLESOLUTION2372
16571-111-48CHLORHEXIDINE GLUCONATE473 mL in 1 BOTTLESOLUTION4732
16571-111-95CHLORHEXIDINE GLUCONATE946 mL in 1 BOTTLESOLUTION9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-111CHLORHEXIDINE GLUCONATE SOLUTION [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20230830_d53a01eb-7213-4f19-b74f-acbf0fd54418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSNd53a01eb-7213-4f19-b74f-acbf0fd544182
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCDd53a01eb-7213-4f19-b74f-acbf0fd544182
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSYd53a01eb-7213-4f19-b74f-acbf0fd544182
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSYd53a01eb-7213-4f19-b74f-acbf0fd544182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-111-1216571011112118 mL in 1 BOTTLE (16571-111-12) 118 ml2023-07-26NoNoCurrent
16571-111-2416571011124237 mL in 1 BOTTLE (16571-111-24) 237 ml2023-07-26NoNoCurrent
16571-111-4816571011148473 mL in 1 BOTTLE (16571-111-48) 473 ml2023-07-26NoNoCurrent
16571-111-9516571011195946 mL in 1 BOTTLE (16571-111-95) 946 ml2023-07-26NoNoCurrent