Hibiclens

Product NDC
76420-535
11-digit product format
764200535
Labeler code
76420
Product ID
76420-535_23b4100e-49d1-0cb6-e063-6394a90a9d24
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
NDA017768
Marketing category
NDA
Marketing start
1976-09-17
Substance
CHLORHEXIDINE GLUCONATE
Active strength
4 g/100mL
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
Hibiclens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui211365, 834167

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
76420-535-08Hibiclens236 mL in 1 BOTTLESOLUTION2363

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-535-08ML - Milliliter76420-535304f2a5d-fca7-4ee7-86cd-f8f7741f217f12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-535HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [ASCLEMED USA, INC.]3Current NDC, 1 package rows20241127_c7363108-0b4e-4d8a-9ec8-ea048604ecb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSNc7363108-0b4e-4d8a-9ec8-ea048604ecb23
834167HIBICLENS 4 % Medicated Liquid SoapPSNc7363108-0b4e-4d8a-9ec8-ea048604ecb23
834167chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]SBDc7363108-0b4e-4d8a-9ec8-ea048604ecb23
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCDc7363108-0b4e-4d8a-9ec8-ea048604ecb23
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSYc7363108-0b4e-4d8a-9ec8-ea048604ecb23
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSYc7363108-0b4e-4d8a-9ec8-ea048604ecb23
834167Hibiclens 4 % Medicated Liquid SoapSYc7363108-0b4e-4d8a-9ec8-ea048604ecb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-535-0876420053508236 mL in 1 BOTTLE (76420-535-08) 236 ml2023-02-03NoNoHistorical