FDA.reportPublic FDA data

NDC 0116-0575-80 - 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
0116-0575-80
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 42 of 47 · 935 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.5fd376ec-d58a-41e3-b974-38527d15c7a82023-11-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
unii: ND2M416302
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e398787-7003-6502-e054-00144ff88e882023-11-03WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e3d67c6-180c-1d9c-e054-00144ff8d46c2023-11-03WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.42b0a0a9-6c5e-45c7-e054-00144ff88e882023-11-03WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e3bcbd1-de23-4d86-e054-00144ff8d46c2023-11-03WarningsExact identifier
unii: MOR84MUD8E
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.43401362-8e54-1f5d-e054-00144ff8d46c2023-11-03WarningsExact identifier
unii: MOR84MUD8E
Isopropyl AlcoholISOPROPYL ALCOHOLA-S Medication Solutionsb44b07a0-91ff-476a-ae0a-080fa01917772023-10-31WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
unii: ND2M416302
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Preps SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd65c8f4de-6516-4caa-a458-228b7b4f6f782023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad 70 Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltdaf84e47f-01d6-d24e-e053-2a95a90a7edd2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad Non-SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd9b835128-194a-4527-abd5-c507ca94b1972023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltda4d1f759-7f35-d277-e053-2a95a90abc8c2023-10-23WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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