FDA.reportPublic FDA data

NDC 0116-0575-08 - 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
0116-0575-08
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 31 of 47 · 935 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorhexidine Gluconate Oral RinseCHLORHEXIDINE GLUCONATE ORAL RINSEBrisk Pharmaceuticals2dcc3920-d9ed-bd56-e063-6294a90a0f3e2025-02-10Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Prevantics SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.9841200b-d4c6-b40c-e053-2995a90a55962025-02-10WarningsExact identifier
unii: MOR84MUD8E
unii: ND2M416302
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Chlorhexidine Gluconate, 0.12% Oral Rinse SolutionCHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSEKesin Pharma Corporation326c15fc-90d8-48de-abd0-61e0c41655292025-02-07Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
unii: ND2M416302
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
unii: ND2M416302
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
unii: ND2M416302
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
unii: ND2M416302
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
unii: ND2M416302
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
unii: ND2M416302
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
unii: ND2M416302
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
SEACALL MouthwashMOUTHWASHGuangdong Quadrant Ecological Technology Co., Ltd.2c1a7eed-6a7c-eeb2-e063-6394a90aafcc2025-01-19WarningsExact identifier
unii: MOR84MUD8E
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEMcKesson Medical-Surgical626d7aa9-b8da-4254-9c57-9007ed4290d42025-01-16WarningsExact identifier
unii: MOR84MUD8E
Alcohol CleansingISOPROPYL ALCOHOLCMC Group Inc.e3985ef1-503a-4193-a5b5-7910aefa78142025-01-13WarningsExact identifier
unii: ND2M416302
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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