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 23 of 48 · 942 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
unii: ND2M416302
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541a1ed-2a92-1fab-e053-2a91aa0a29d12025-10-23WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESage Products LLC3c754532-d9a5-f876-00c4-05a4c9b21efa2025-10-21Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
unii: ND2M416302
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
unii: ND2M416302
PROHEAL ALCOHOL XXL PREP PADSISOPROPYL ALCOHOLClick Industries LLCec81be59-94a5-4675-9047-e3e82d7ad7612025-10-20WarningsExact identifier
unii: ND2M416302
ALCOHOL PREP PADISOPROPYL ALCOHOLGuangdong Comfort Medical Products Co., Ltd.3a2dea43-8123-3fb7-e063-6294a90a5e502025-10-19WarningsExact identifier
unii: ND2M416302
Krx Aesthetics Biophase Molecular Night PeelKRX AESTHETICS BIOPHASE MOLECULAR NIGHT PEELKRX RESOURCES SDN. BHD.3dd69bcb-3743-eb01-e063-6394a90ab7e02025-10-18WarningsExact identifier
unii: WQ29KQ9POT
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85790749-5a95-7f18-e053-2a91aa0a1a022025-10-17WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85791e13-4103-19fe-e053-2991aa0a647f2025-10-17WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85794f6b-d1ea-40f9-e053-2991aa0a88232025-10-17WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302
ChloraPrep SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLC1666069b-38f6-bfde-e063-6394a90ad1b82025-10-17WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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