FDA.reportPublic FDA data

NDC 0116-0575-91 - 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
Requested NDC
0116-0575-91
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 45 of 47 · 935 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEDen-mat Holdings, Llca2d2d555-89a5-42d7-81d5-50fd7e741f832023-02-09Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEDarby Dental Supply, LLC0f8bc307-3069-45f2-aa03-8a4178d562a92023-01-12Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Chlorhexidine Gluconate Solution 0.75% AntisepticCHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTICBajaj Medical, LLC014a5f36-0396-498b-901f-9a86df4e11fe2022-12-26WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.9dc6d487-b51b-985b-e053-2995a90a88232022-12-26WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.9dc69556-aebe-1270-e053-2a95a90a69a92022-12-26WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.9dc6d545-f831-9692-e053-2995a90adec52022-12-26WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.9dc60323-ed7c-199a-e053-2995a90a74b82022-12-26WarningsExact identifier
unii: MOR84MUD8E
Provon Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2%Gojo Industries, Inc.365c3ac6-6c1f-594b-e054-00144ff88e882022-12-20WarningsExact identifier
unii: MOR84MUD8E
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEProficient Rx LP504735e2-b13b-41c4-b2ed-5991f53b6fb62022-12-01Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.4c133721-ad9a-4807-8ad5-c3efdff1ec522022-11-28WarningsExact identifier
unii: MOR84MUD8E
Bactoshield CHG Chlorhexidine GluconateCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.46084e90-6ffa-4e1a-a8ff-1c1b1484fe882022-11-28WarningsExact identifier
unii: MOR84MUD8E
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sky Oral RinseCHLORHEXIDINE GLUCONATEMcKessonb479c166-899b-0565-e053-2995a90a20942022-09-26Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af49488d-5aeb-e3d9-e053-2a95a90afb042022-08-31WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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