FDA.reportPublic FDA data

Hibiclens

Product NDC
0234-0575
11-digit product format
002340575
Labeler code
0234
Product ID
0234-0575_29f35571-d7a5-b30f-e063-6394a90aca88
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Molnlycke Health Care
Application
NDA017768
Marketing category
NDA
Marketing start
2016-02-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0234-0575-042024-06-18C16284748780-1f386c649-bc2c-0266-e053-dadaa90a7c1aHibiclens, 4% CHG
0234-0575-082024-06-18C16284748780-1f386c649-bc2c-0266-e053-dadaa90a7c1aHibiclens, 4% CHG
0234-0575-162024-06-18C16284748780-1f386c649-bc2c-0266-e053-dadaa90a7c1aHibiclens, 4% CHG
0234-0575-172024-06-18C16284748780-1f386c649-9c9e-0266-e053-dadaa90a7c1aHibiclens, 4% CHG, packette
0234-0575-322024-06-18C16284748780-1f386c649-bc2c-0266-e053-dadaa90a7c1aHibiclens, 4% CHG
0234-0575-402024-06-18C16284748780-1f386c649-a404-0266-e053-dadaa90a7c1aHibiclens IFP
0234-0575-412024-06-18C16284748780-1f386c649-a404-0266-e053-dadaa90a7c1aHibiclens IFP
0234-0575-912024-06-18C16284748780-1f386c649-bc2c-0266-e053-dadaa90a7c1aHibiclens, 4% CHG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0234-0575-40Hibiclens118 mL in 1 BOTTLESOLUTION11814
0234-0575-41Hibiclens118 mL in 1 BOTTLE, PUMPSOLUTION11814
0234-0575-80Hibiclens236 mL in 1 BOTTLE, PUMPSOLUTION23614
0234-0575-04Hibiclens118 mL in 1 BOTTLESOLUTION11813
0234-0575-08Hibiclens236 mL in 1 BOTTLESOLUTION23613
0234-0575-16Hibiclens473 mL in 1 BOTTLESOLUTION47313
0234-0575-32Hibiclens946 mL in 1 BOTTLESOLUTION94613
0234-0575-91Hibiclens3790 mL in 1 BOTTLESOLUTION379013
0234-0575-17Hibiclens50 in 1 CARTONSOLUTION5011
0234-0575-17Hibiclens15 mL in 1 PACKETSOLUTION1511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0234-0575-04ML - Milliliter0234-05752c7f09fc-94c5-4fc5-b48c-71188619df1812012-07-24
0234-0575-08ML - Milliliter0234-05759eea668e-5fde-456f-a7ee-3251bffca1c512012-07-24
0234-0575-16ML - Milliliter0234-05750cc2b373-1d80-4637-99b6-75fb80ba95a212012-07-24
0234-0575-17ML - Milliliter0234-057594926e3b-31c8-456c-8dea-5c4ed2b69cdd12012-07-24
0234-0575-32ML - Milliliter0234-0575588c6c29-dfd9-40e4-ba05-8544184bdfca12012-07-24
0234-0575-40ML - Milliliter0234-0575b49c8b95-df57-4aea-b30b-e4892191a03712017-11-06
0234-0575-41ML - Milliliter0234-05752d7ae4b3-648f-4ab7-bb82-dca7abcd265c12019-12-10
0234-0575-80ML - Milliliter0234-0575d0508c6d-a36c-46d0-be06-7f8f2d689bb712026-04-20
0234-0575-91ML - Milliliter0234-05757ea5bf35-011c-4299-a7e2-29b0c6ecbb6e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8EHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
POLOXAMER 237INACTIVE INGREDIENTJT3U72U71KHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]4
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8EHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
POLOXAMER 237INACTIVE INGREDIENTJT3U72U71KHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE US, LLC]2
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8EHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52LHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Isopropyl alcoholINACTIVE INGREDIENTND2M416302HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RHIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0234-0575HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE]14Current NDC, Legacy NDC, 3 package rows20241225_29b547bf-c08e-14c2-e054-00144ff88e88.zip
0234-0575HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE]13Current NDC, Legacy NDC, 5 package rows20241225_4275eb53-1a7e-4a91-aac1-1085f40fac88.zip
0234-0575HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE]11Current NDC, Legacy NDC, 2 package rows20241225_8b37a721-79bb-4051-95a7-fcb4edebfcb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN29b547bf-c08e-14c2-e054-00144ff88e8814
834167HIBICLENS 4 % Medicated Liquid SoapPSN29b547bf-c08e-14c2-e054-00144ff88e8814
834167chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]SBD29b547bf-c08e-14c2-e054-00144ff88e8814
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD29b547bf-c08e-14c2-e054-00144ff88e8814
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY29b547bf-c08e-14c2-e054-00144ff88e8814
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY29b547bf-c08e-14c2-e054-00144ff88e8814
834167Hibiclens 4 % Medicated Liquid SoapSY29b547bf-c08e-14c2-e054-00144ff88e8814
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN4275eb53-1a7e-4a91-aac1-1085f40fac8813
834167HIBICLENS 4 % Medicated Liquid SoapPSN4275eb53-1a7e-4a91-aac1-1085f40fac8813
834167chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]SBD4275eb53-1a7e-4a91-aac1-1085f40fac8813
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD4275eb53-1a7e-4a91-aac1-1085f40fac8813
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY4275eb53-1a7e-4a91-aac1-1085f40fac8813
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY4275eb53-1a7e-4a91-aac1-1085f40fac8813
834167Hibiclens 4 % Medicated Liquid SoapSY4275eb53-1a7e-4a91-aac1-1085f40fac8813
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN8b37a721-79bb-4051-95a7-fcb4edebfcb711
834167HIBICLENS 4 % Medicated Liquid SoapPSN8b37a721-79bb-4051-95a7-fcb4edebfcb711
834167chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]SBD8b37a721-79bb-4051-95a7-fcb4edebfcb711
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD8b37a721-79bb-4051-95a7-fcb4edebfcb711
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY8b37a721-79bb-4051-95a7-fcb4edebfcb711
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY8b37a721-79bb-4051-95a7-fcb4edebfcb711
834167Hibiclens 4 % Medicated Liquid SoapSY8b37a721-79bb-4051-95a7-fcb4edebfcb711
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 startMarketing endSampleExclude flagStatus
0234-0575-0400234057504118 mL in 1 BOTTLE (0234-0575-04) 118 ml1976-09-170000-00-00NoNoCurrent
0234-0575-0800234057508236 mL in 1 BOTTLE (0234-0575-08) 236 ml1976-09-170000-00-00NoNoCurrent
0234-0575-1600234057516473 mL in 1 BOTTLE (0234-0575-16) 473 ml1976-09-170000-00-00NoNoCurrent
0234-0575-170023405751750 PACKET in 1 CARTON (0234-0575-17) / 15 mL in 1 PACKET50 packet1976-09-170000-00-00NoNoCurrent
0234-0575-3200234057532946 mL in 1 BOTTLE (0234-0575-32) 946 ml1976-09-170000-00-00NoNoCurrent
0234-0575-4000234057540118 mL in 1 BOTTLE (0234-0575-40) 118 ml2016-02-150000-00-00NoNoCurrent
0234-0575-4100234057541118 mL in 1 BOTTLE, PUMP (0234-0575-41) 118 ml2019-02-010000-00-00NoNoCurrent
0234-0575-8000234057580236 mL in 1 BOTTLE, PUMP (0234-0575-80) 236 ml2024-01-01NoNoHistorical
0234-0575-91002340575913790 mL in 1 BOTTLE (0234-0575-91) 3790 ml1976-09-170000-00-00NoNoCurrent