FDA.reportPublic FDA data

NDC 0116-0575 - Hibiclens

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0116-0575
Package NDCs from labels
0116-0575-41, 0116-0575-91, 0116-0575-04, 0116-0575-08, 0116-0575-80, 0116-0575-16, 0116-0575-32
Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hibiclens 4% CHG 4oz Foamer, 4oz, 8oz Foamer, 8oz, 16oz, 32oz 1 gallonXttrium Laboratories, Inc.2025-04-29HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0575HIBICLENS (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Unmatched20250519_102afe55-eb58-971b-e063-6394a90ae9b0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 48 · 942 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsExact identifier
unii: MOR84MUD8E
Bactoshield CHGCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.ee0317ff-0988-7621-e053-2a95a90a13fe2026-04-27WarningsExact identifier
unii: MOR84MUD8E
Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4a645652-ae2f-3811-e054-00144ff8d46c2026-04-27WarningsExact identifier
unii: MOR84MUD8E
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e0-0a10-e054-00144ff88e882026-04-27Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsExact identifier
unii: MOR84MUD8E
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a684f-5f72-347a-e054-00144ff8d46c2026-04-27Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
CliniCleanCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.f8352f15-b481-ee95-e053-6294a90ac5352026-04-27WarningsExact identifier
unii: MOR84MUD8E
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6cc89ac1-baef-40bb-85a3-d9ae9e3e7a632026-04-27WarningsExact identifier
unii: MOR84MUD8E
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
unii: ND2M416302
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302
3M AvagardCHLORHEXIDINE GLUCONATE AND ALCOHOLSolventum US LLC8bf8fe8e-76cb-4eda-a18d-1687050285ae2026-04-22WarningsExact identifier
unii: MOR84MUD8E
DASH Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSECardinal Health 107, LLC0253513c-148c-4be7-a6d5-5528f40806fa2026-04-16Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD4f8ba6c8-5155-c491-e063-6394a90adde92026-04-15WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWinCo Foods, LLCc22a5fc3-78f5-4660-96a6-479ca6f776022026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLWinCo Foods, LLC2b48ee19-8f0c-4b36-855d-7909dde5c8712026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.