FDA.reportPublic FDA data

Application 019125

Type
NDA
Sponsor
XTTRIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXIDINECHLORHEXIDINE GLUCONATESOLUTION;TOPICAL4%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019125-001DYNA-HEX 4CHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICAL1984-12-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019125-001EXIDINE4%SOLUTION / TOPICAL1984-12-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019125-001DYNA-HEX 44%SOLUTION / TOPICAL1984-12-24a50c72e98297…

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 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dyna-Hex 4CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.0a32c299-f7ca-d15c-e063-6294a90af2c12026-04-30WarningsExact identifier
ndc (product): 0116-1060
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Meijer Distribution, Inc.2821b691-0ece-0e35-e054-00144ff8d46c2026-04-29WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 41250-162
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-1344
Bactoshield CHGCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.ee0317ff-0988-7621-e053-2a95a90a13fe2026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-0039
Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4a645652-ae2f-3811-e054-00144ff8d46c2026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-0061
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-0407
CliniCleanCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.f8352f15-b481-ee95-e053-6294a90ac5352026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic SolutionCHLORHEXIDINE GLUCONATE 4%Coloplast Corpc4e4068b-5e5e-a571-e053-2995a90a98a52026-03-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 11701-172
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%CVS Pharmacy, Inc.46dc074c-af71-4805-e054-00144ff8d46c2026-03-03WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.48a814e7-bfe4-5437-e054-00144ff88e882026-03-03WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-0767
BETASEPTANTISEPTIC SURGICAL SCRUBAtlantis Consumer Healthcare, Inc.7e64e7bf-e88f-4056-c9e1-b49a277daa6c2025-12-24WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
CliniCleanCHLORHEXIDINE GLUCONATE 4%HR Pharmaceuticals, Inc.f7959667-6275-802a-e053-6394a90aa7f12025-12-16WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Foster and ThriveCHLORHEXIDINE GLUCONATE 4%McKesson Corporation08b60f82-01db-3451-e063-6294a90a2bdc2025-12-16WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATECardinal Health7a7aeecf-ce26-5a66-e053-2991aa0ad4a22025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%AmerisourceBergen Drug Corporation12ace9af-14ed-2dea-e054-00144ff8d46c2025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 46122-137
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Topco Associates LLCa0b7180a-0257-4a64-9d1a-6b6d824fac1c2025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 36800-401
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Chain Drug Marketing Association Inc.12234b17-fd07-6088-e054-00144ff88e882025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4aa41583-790c-2446-e054-00144ff8d46c2025-12-10WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-3678
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.9f6342f7-faa3-4d23-a860-054d04cb8d422025-12-10WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-1061
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4a64f7c5-829c-6184-e054-00144ff88e882025-12-08WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (product): 0116-0137

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0116-0039Bactoshield CHGChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0039Bactoshield CHGChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0061Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0061Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0137Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0161Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0200BETASEPTAntiseptic Surgical ScrubXttrium Laboratories, Inc.NDACurrent
0116-0200BETASEPTAntiseptic Surgical ScrubXttrium Laboratories, Inc.NDACurrent
0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0228Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0237Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-0407ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-0407ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-0767Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-1060DYNA-HEX 4Chlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1060DYNA-HEX 4Chlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1060DYNA-HEX 4Chlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, IncNDACurrent
0116-1061ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-1272Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-1344Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.NDACurrent
0116-1610Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-1610Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine GluconateXttrium Laboratories, Inc.NDACurrent
0116-2994Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Xttrium Laboratories, Inc.NDACurrent
0116-4444Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0116-4444Scrub CareChlorhexidine gluconateXttrium Laboratories, Inc.NDACurrent
0363-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%Walgreen Co.NDACurrent
0363-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%Walgreen Co.NDACurrent
0404-1061Antiseptic Skin CleanserChlorhexidine Gluconate 4%Henry Schein, Inc.NDACurrent
0519-1344Bactoshield CHGCHLORHEXIDINE GLUCONATESTERIS CorporationNDACurrent
11084-039Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.NDACurrent
11084-815Bactoshield CHGCHLORHEXIDINE GLUCONATEDeb USA, Inc.NDACurrent
11084-815Bactoshield CHGCHLORHEXIDINE GLUCONATEDeb USA, Inc.NDACurrent
11701-172Antiseptic SolutionChlorhexidine Gluconate 4%Coloplast CorpNDACurrent
11822-0116Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite AidNDACurrent
11822-0891Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite AidNDACurrent
11822-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite Aid CorporationNDACurrent
11822-3678Antiseptic Skin CleanserChlorhexidine Gluconate 4%Rite Aid CorporationNDACurrent
36800-401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Topco Associates LLCNDACurrent
36800-401Antiseptic Skin CleanserChlorhexidine Gluconate 4%Topco Associates LLCNDACurrent
37205-595ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATECardinal HealthNDACurrent
37205-595ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATECardinal HealthNDACurrent
37205-595ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATECardinal HealthNDACurrent
41250-162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Meijer Distribution, Inc.NDACurrent
41250-162Antiseptic Skin CleanserChlorhexidine Gluconate 4%Meijer Distribution, Inc.NDACurrent
46122-137Antiseptic Skin CleanserChlorhexidine Gluconate 4%AmerisourceBergen Drug CorporationNDACurrent
49348-115Antiseptic Skin CleanserChlorhexidine Gluconate 4%McKessonNDACurrent
49348-115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Strategic Sourcing Services, LLCNDACurrent
49348-115Antiseptic Skin CleanserChlorhexidine Gluconate 4%Strategic Sourcing Services, LLCNDACurrent
49738-161Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Kmart CorporationNDACurrent
49738-161Smart Sense Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Kmart CorporationNDACurrent
52380-1272Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1986Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1986Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare Products, LLC.NDACurrent
52380-1987Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare, Inc.NDACurrent
52380-1987Aplicare Antiseptic Chlorhexidine GluconateChlorhexidine GluconateAplicare Products, LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84909SUPPL 2026-02-05
84908SUPPL 2026-02-05
72251SUPPL2022-10-05
72197SUPPL2022-09-30
49827SUPPL2017-09-21
49800SUPPL2017-09-19
33699SUPPL2014-10-30
16201SUPPL2014-10-22
1231SUPPL2012-11-13
16200SUPPL2005-05-18
20207SUPPL2003-09-11