Chlorhexidine Topical Solution

Brand(s)
Bactoshield, Dyna-Hex
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Aplicare, Inc. (2015-08-12)
Oldest Current Product
1998-09-01
License(s)
NDA, EXPORT ONLY, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
TOPICAL SOLUTION\CHLORHEXIDINE
FDAOB
TOPICAL\SOLUTION\CHLORHEXIDINE GLUCONATE
TOPICAL\SPONGE\CHLORHEXIDINE GLUCONATE
SPL Active
TOPICAL\LIQUID\CHLORHEXIDINE GLUCONATE
TOPICAL\LOTION\CHLORHEXIDINE GLUCONATE
TOPICAL\SOLUTION\CHLORHEXIDINE GLUCONATE
TOPICAL\SPONGE\CHLORHEXIDINE GLUCONATE
SPL Moiety
TOPICAL\LIQUID\CHLORHEXIDINE
TOPICAL\LOTION\CHLORHEXIDINE
TOPICAL\SOLUTION\CHLORHEXIDINE
TOPICAL\SPONGE\CHLORHEXIDINE

product(s) by strength(s)

chlorhexidine gluconate 20 mg/ml topical solution

export only product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1429390103EXPORT ONLYAva, Inc.2012-12-16CHLORHEXIDINE GLUCONATETOPICALSOLUTION37d3c63e-8177-482a-8c5a-86ae7f3905c4

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005191322NDASteris Corporation1999-10-04CHLORHEXIDINE GLUCONATETOPICALSOLUTIONNDA0194226420bbef-a828-4966-906c-164a8d1bbf28
2523801919NDAAplicare, Inc.1998-09-01CHLORHEXIDINE GLUCONATETOPICALSOLUTIONNDA0194220beaf7da-fe4b-65cb-e054-00144ff88e88

chlorhexidine gluconate 40 mg/ml topical solution

export only product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1429390102EXPORT ONLYAva, Inc.2012-12-06CHLORHEXIDINE GLUCONATETOPICALSOLUTION76cfedb3-25ed-4c12-8ebc-b57f029fedaa

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005191364BactoshieldNDASteris Corporation2003-03-27CHLORHEXIDINE GLUCONATETOPICALSPONGENDA019822ec19f244-662c-4643-8be0-6d96a0d07801
2372050595NDACardinal Health2012-01-01CHLORHEXIDINE GLUCONATETOPICALLIQUIDNDA0191255577ecbb-cf2c-45e1-a0fb-17df0417eea5

chlorhexidine gluconate 5 mg/ml topical solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1518110066UNAPPROVED DRUG OTHER MARKETING CATEGORYHanover Pen Corp Dba Hpc Global2013-02-01CHLORHEXIDINE GLUCONATETOPICALLOTIONeee2947c-07cd-440b-8b98-406b88366f05
2518110658UNAPPROVED DRUG OTHER MARKETING CATEGORYHanover Pen Corp Dba Hpc Global2013-02-01CHLORHEXIDINE GLUCONATETOPICALLOTION25f64ae2-fc3a-4fc5-b659-98cb5c6fa199

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070104STERI-STATTrueMATRIX MEDICAL CORP1986-07-24ANDA070104_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
2ANDA071419BRIAN CARESOAPCO INC1987-12-17ANDA071419_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
3ANDA072255MICRODERMTrueJOHNSON AND JOHNSON MEDICAL INC1991-04-15ANDA072255_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
4ANDA072292PREVACARE RTrueJOHNSON AND JOHNSON MEDICAL INC1992-01-28ANDA072292_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
5ANDA072295MICRODERMTrueJOHNSON AND JOHNSON MEDICAL INC1991-02-28ANDA072295_001Chlorhexidine Medicated Liquid Soap
6ANDA072525CHLORHEXIDINE GLUCONATEBECTON DICKINSON AND CO1989-10-24ANDA072525_001Chlorhexidine Medicated Liquid Soap
7ANDA073416E-Z SCRUBTrueBECTON DICKINSON SURGICAL SYSTEM2000-03-14ANDA073416_001Chlorhexidine Medicated Liquid Soap
8NDA017768HIBICLENSMOLNLYCKE HEALTH CARENDA017768_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
9NDA018300HIBISTATMOLNLYCKE HEALTH CARENDA018300_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
10NDA018423HIBICLENSTrueMOLNLYCKE HEALTH CARENDA018423_001Chlorhexidine Medicated Liquid Soap
11NDA019125EXIDINEXTTRIUM LABORATORIES INC1984-12-24NDA019125_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
12NDA019258CHG SCRUBECOLAB INC1986-07-22NDA019258_001, NDA019258_002Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
13NDA019421EXIDINETrueXTTRIUM LABORATORIES INC1985-12-17NDA019421_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
14NDA019422EXIDINEXTTRIUM LABORATORIES INC1985-12-17NDA019422_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap
15NDA019490CHLORHEXIDINE GLUCONATETrueKENDALL CO1987-03-27NDA019490_001Chlorhexidine Medicated Liquid Soap
16NDA019793PHARMASEAL SCRUB CARECAREFUSION 213 LLC1988-12-02NDA019793_001Chlorhexidine Medicated Liquid Soap
17NDA019822BIOSCRUBKW GRIFFEN CO1989-03-31NDA019822_001Chlorhexidine Medicated Liquid Soap
18NDA020111DYNA-HEXBAJAJ MECICAL LLC1997-09-11NDA020111_001Chlorhexidine Medicated Pad
Chlorhexidine Medicated Liquid Soap

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070104_001discontinuedCHLORHEXIDINE GLUCONATE (4%)TOPICALSOLUTIONFalse1986-07-24STERI-STAT
2ANDA071419_001OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSOLUTIONFalse1987-12-17BRIAN CARE
3ANDA072255_001discontinuedCHLORHEXIDINE GLUCONATE (4%)TOPICALSOLUTIONFalse1991-04-15MICRODERM
4ANDA072292_001discontinuedCHLORHEXIDINE GLUCONATE (0.5%)TOPICALSOLUTIONFalse1992-01-28PREVACARE R
5ANDA072295_001discontinuedCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGEFalse1991-02-28MICRODERM
6ANDA072525_001OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGEFalse1989-10-24CHLORHEXIDINE GLUCONATE
7ANDA073416_001discontinuedCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGEFalse2000-03-14E-Z SCRUB
8NDA017768_001OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSOLUTIONTrueHIBICLENS
9NDA018300_001OTCCHLORHEXIDINE GLUCONATE (0.5%)TOPICALSOLUTIONTrueHIBISTAT
10NDA018423_001discontinuedCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGEFalseHIBICLENS
11NDA019125_001OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSOLUTIONFalse1984-12-24EXIDINE
12NDA019258_001OTCCHLORHEXIDINE GLUCONATE (2%)TOPICALSOLUTIONFalse1986-07-22CHG SCRUB
13NDA019258_002OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSOLUTIONFalse1986-07-22CHG SCRUB
14NDA019421_001discontinuedCHLORHEXIDINE GLUCONATE (2.5%)TOPICALSOLUTIONFalse1985-12-17EXIDINE
15NDA019422_001OTCCHLORHEXIDINE GLUCONATE (2%)TOPICALSOLUTIONTrue1985-12-17EXIDINE
16NDA019490_001discontinuedCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGEFalse1987-03-27CHLORHEXIDINE GLUCONATE
17NDA019793_001OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGETrue1988-12-02PHARMASEAL SCRUB CARE
18NDA019822_001OTCCHLORHEXIDINE GLUCONATE (4%)TOPICALSPONGEFalse1989-03-31BIOSCRUB
19NDA020111_001OTCCHLORHEXIDINE GLUCONATE (0.75%)TOPICALSOLUTIONFalse1997-09-11DYNA-HEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10beaf7da-fe4b-65cb-e054-00144ff88e88 (view SPL)Drug FactsotcHuman OTCAplicare, Inc.2015-08-126523801919
225f64ae2-fc3a-4fc5-b659-98cb5c6fa199 (view SPL)Drug FactsotcHuman OTCHanover Pen Corp Dba Hpc Globallabel, manufacture, repack2013-02-011518110658
337d3c63e-8177-482a-8c5a-86ae7f3905c4 (view SPL)Antiseptic Skin Cleanser(Chlorhexidine Gluconate 2% Topical Solution, USP)otcHuman OTCAva, Inc.manufacture2012-12-161429390103
45577ecbb-cf2c-45e1-a0fb-17df0417eea5 (view SPL)Drug FactsprescriptionHuman PrescriptionCardinal Healthmanufacture2012-09-262372050595
56420bbef-a828-4966-906c-164a8d1bbf28 (view SPL)Bactoshield CHG 2% Chlorhexidine Gluconate 2% SolutionotcHuman OTCSteris CorporationMANUFACTURE2014-06-055005191322
66a77ef12-825d-4b37-8c1c-6540bf7970c4 (view SPL)Drug FactsotcHuman OTCAplicare, Inc.repack2010-06-093523801274
76cc89ac1-baef-40bb-85a3-d9ae9e3e7a63 (view SPL)Drug FactsotcHuman OTCPuretek Corporationmanufacture2014-01-273001161021
876cfedb3-25ed-4c12-8ebc-b57f029fedaa (view SPL)Antiseptic Skin Cleanser(Chlorhexidine Gluconate 4% Solution)otcHuman OTCAva, Inc.manufacture2012-12-061429390102
9cd223ce2-b307-4202-ae89-dd96c78c5d57 (view SPL)Bactoshield CHG Chlorhexidine Gluconate SolutionotcHuman OTCSteris CorporationMANUFACTURE2013-08-164005191344
10dfdaa646-0ef5-4433-b8d3-39ec139827b9 (view SPL)Drug FactsotcHuman OTCPreferred Plus (Kinray)manufacture2013-08-012617150072
11ec19f244-662c-4643-8be0-6d96a0d07801 (view SPL)Bactoshield CHG 4% Surgical ScrubotcHuman OTCSteris CorporationMANUFACTURE2014-03-122005191364
12eee2947c-07cd-440b-8b98-406b88366f05 (view SPL)Drug FactsotcHuman OTCHanover Pen Corp Dba Hpc Globallabel, manufacture, repack2013-02-011518110066

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII