Chlorhexidine Mouthwash

Brand(s)
Oris, Paroex, Peridex, Periogard
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Hi-Tech Pharmacal Co., Inc. (2015-11-13)
Oldest Current Product
1986-08-13
License(s)
NDA, ANDA, OTC MONOGRAPH NOT FINAL
RxNORM
MOUTHWASH\CHLORHEXIDINE
FDAOB
DENTAL\SOLUTION\CHLORHEXIDINE GLUCONATE
SPL Active
BUCCAL\LIQUID\CHLORHEXIDINE GLUCONATE
BUCCAL\MOUTHWASH\CHLORHEXIDINE GLUCONATE: HYDROGEN PEROXIDE
DENTAL\LIQUID\CHLORHEXIDINE GLUCONATE
ORAL\LIQUID\CHLORHEXIDINE GLUCONATE
ORAL\RINSE\CHLORHEXIDINE GLUCONATE
SPL Moiety
BUCCAL\LIQUID\CHLORHEXIDINE
BUCCAL\MOUTHWASH\CHLORHEXIDINE: HYDROGEN PEROXIDE
DENTAL\LIQUID\CHLORHEXIDINE
ORAL\LIQUID\CHLORHEXIDINE
ORAL\RINSE\CHLORHEXIDINE

product(s) by strength(s)

chlorhexidine gluconate 1.2 mg/ml mouthwash

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1488780620PeridexNDA3M Espe Dental Products1986-08-13CHLORHEXIDINE GLUCONATEORALRINSENDA0190283fcd41c4-875a-4e54-b533-261f198011af
2534620594OTC MONOGRAPH NOT FINALSage Products, Inc.2014-07-01CHLORHEXIDINE GLUCONATE, HYDROGEN PEROXIDEBUCCALMOUTHWASH12d254ce-831a-54cd-221b-33c205f99696
3534620924OTC MONOGRAPH NOT FINALSage Products, Inc.2007-12-31CHLORHEXIDINE GLUCONATE, HYDROGEN PEROXIDEBUCCALMOUTHWASH21843493-2870-a8ca-7be1-424237830f98
4534620932OTC MONOGRAPH NOT FINALSage Products, Inc.2007-12-31CHLORHEXIDINE GLUCONATE, HYDROGEN PEROXIDEBUCCALMOUTHWASHe7e9802d-c8b2-f0cb-6a81-56019e13dbf7

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001162001ANDAPuretek Corporation2009-08-01CHLORHEXIDINE GLUCONATEORALRINSEANDA07778934d15e72-8770-49dc-a514-d44ae4468a1e
2001260271PeriogardANDAColgate Oral Pharmaceuticals, Inc.2010-03-02CHLORHEXIDINE GLUCONATEORALLIQUIDANDA0736956e537d5f-bce1-41ce-9984-9b3c2861b7c9
3503830720ANDAHi-Tech Pharmacal Co., Inc.1996-05-07CHLORHEXIDINE GLUCONATEORALRINSEANDA074356ab45e02b-22e5-46f3-a025-d0156b3ad55c
4523760021ParoexANDASunstar Americas, Inc.2014-10-31CHLORHEXIDINE GLUCONATEORALRINSEANDA0764344e137308-6a21-4bf9-802f-23ff78ee6797
5534620003ANDASage Products, Inc.2014-01-20CHLORHEXIDINE GLUCONATEBUCCALLIQUIDANDA0777893c754532-d9a5-f876-00c4-05a4c9b21efa
6598830175ANDAZila, Inc.2009-06-18CHLORHEXIDINE GLUCONATEORALRINSEANDA077789a2d2d555-89a5-42d7-81d5-50fd7e741f83
7664672560ANDADarby Dental Supply, Llc2006-07-02CHLORHEXIDINE GLUCONATEDENTALLIQUIDANDA0777890f8bc307-3069-45f2-aa03-8a4178d562a9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1244510001ANDALlc Federal Solutions2013-06-24CHLORHEXIDINE GLUCONATEORALRINSE001162001ANDA077789b601b1c5-48ca-445e-bc35-fcf268281539
2551549625ANDACardinal Health1996-05-07CHLORHEXIDINE GLUCONATEORALRINSE503830720ANDA0743561ea4f331-1658-416b-9a54-e3d18dd4a554
3631870524ANDAProficient Rx Lp1996-05-07CHLORHEXIDINE GLUCONATEORALRINSE503830720ANDA07435643a8c4e8-3679-485d-88fc-8bccdba7de1e
4687889426ANDAPreferred Pharmaceuticals, Inc.2014-04-21CHLORHEXIDINE GLUCONATEORALRINSE503830720ANDA074356f2d2677e-8bd1-4c1c-8991-ea07009490d5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073695PERIOGARDCOLGATE ORAL PHARMACEUTICALS INC1994-01-14ANDA073695_001
2ANDA074291CHLORHEXIDINE GLUCONATELYNE LABORATORIES INC1995-12-28ANDA074291_001
3ANDA074356CHLORHEXIDINE GLUCONATEHI TECH PHARMACAL CO INC1996-05-07ANDA074356_001
4ANDA074522CHLORHEXIDINE GLUCONATETEVA PHARMACEUTICALS USA INC1995-12-15ANDA074522_001
5ANDA075006CHLORHEXIDINE GLUCONATEWOCKHARDT EU OPERATIONS (SWISS) AG2004-03-03ANDA075006_001
6ANDA075561CHLORHEXIDINE GLUCONATETrueAPOTEX INC2000-11-14ANDA075561_001
7ANDA076434PAROEXSUNSTAR AMERICAS INC2005-11-29ANDA076434_001
8ANDA077789CHLORHEXIDINE GLUCONATEXTTRIUM LABORATORIES INC2009-06-18ANDA077789_001
9NDA019028PERIDEX3M CO1986-08-13NDA019028_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073695_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT1994-01-14PERIOGARD
2ANDA074291_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT1995-12-28CHLORHEXIDINE GLUCONATE
3ANDA074356_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT1996-05-07CHLORHEXIDINE GLUCONATE
4ANDA074522_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT1995-12-15CHLORHEXIDINE GLUCONATE
5ANDA075006_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT2004-03-03CHLORHEXIDINE GLUCONATE
6ANDA075561_001discontinuedCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalse2000-11-14CHLORHEXIDINE GLUCONATE
7ANDA076434_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT2005-11-29PAROEX
8ANDA077789_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONFalseAT2009-06-18CHLORHEXIDINE GLUCONATE
9NDA019028_001RXCHLORHEXIDINE GLUCONATE (0.12%)DENTALSOLUTIONTrueAT1986-08-13PERIDEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10f8bc307-3069-45f2-aa03-8a4178d562a9 (view SPL)Superdent 0.12 % Chlorhexidine Gluconate Oral Rinse MintprescriptionHuman PrescriptionDarby Dental Supply, Llc2013-10-092664672560
212d254ce-831a-54cd-221b-33c205f99696 (view SPL)Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse, q4otcHuman OTCSage Products, Inc.MANUFACTURE2014-07-101534620594
31ea4f331-1658-416b-9a54-e3d18dd4a554 (view SPL)CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%prescriptionHuman PrescriptionCardinal HealthREPACK2014-02-051551549625
421843493-2870-a8ca-7be1-424237830f98 (view SPL)QCare Rx Oral Cleansing and Suctioning System, Q4otcHuman OTCSage Products, Inc.MANUFACTURE2014-03-061534620924
521eb36ec-b44c-93e7-3547-2d68ce31b44b (view SPL)QCare Rx Oral Cleansing and Suctioning System, Q4otcHuman OTCSage Products, Inc.MANUFACTURE2014-03-111534620904
634d15e72-8770-49dc-a514-d44ae4468a1e (view SPL)prescriptionHuman PrescriptionPuretek Corporationmanufacture2015-10-083001162001
73b467496-dde7-6c24-418f-68843a8acce5 (view SPL)Oral Cleansing and Suctioning System, q2otcHuman OTCSage Products, Inc.MANUFACTURE2014-07-091534620592
83c754532-d9a5-f876-00c4-05a4c9b21efa (view SPL)Chlorhexidine Gluconate 0.12% Oral RinseprescriptionHuman PrescriptionSage Products, Inc.MANUFACTURE2014-03-041534620003
93fcd41c4-875a-4e54-b533-261f198011af (view SPL)Peridex (Chlorhexidine Gluconate 0.12%) Oral RinseprescriptionHuman Prescription3M Espe Dental Products2013-01-2510488780620
1043a8c4e8-3679-485d-88fc-8bccdba7de1e (view SPL)CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870524
114e137308-6a21-4bf9-802f-23ff78ee6797 (view SPL)Paroex (Chlorhexidine Gluconate OralRinse USP, 0.12%)prescriptionHuman PrescriptionSunstar Americas, Inc.2014-11-109523760021
126e537d5f-bce1-41ce-9984-9b3c2861b7c9 (view SPL)PerioGard (Chlorhexidine Gluconate Oral Rinse, 0.12%)prescriptionHuman PrescriptionColgate Oral Pharmaceuticals, Inc.2010-03-054001260271
138d90c38e-e241-4f73-877d-ff314408a510 (view SPL)ORIS Chlorhexidine Gluconate Oral Rinse, 0.12%prescriptionHuman PrescriptionDentsply Professional2015-05-191652220720
14a2d2d555-89a5-42d7-81d5-50fd7e741f83 (view SPL)Chlorhexidine GluconateprescriptionHuman PrescriptionZila, Inc.MANUFACTURE2013-10-235598830175
15ab45e02b-22e5-46f3-a025-d0156b3ad55c (view SPL)Chlorhexidine Gluconate Oral Rinse, 0.12%prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2015-11-139503830720
16b601b1c5-48ca-445e-bc35-fcf268281539 (view SPL)prescriptionHuman PrescriptionLlc Federal Solutionsrepack2013-08-205244510001
17e7e9802d-c8b2-f0cb-6a81-56019e13dbf7 (view SPL)QCare Rx Oral Cleansing and Suctioning SystemotcHuman OTCSage Products, Inc.MANUFACTURE2014-03-061534620932
18e8d23d6a-3828-8c4c-1561-287bab6cb834 (view SPL)QCare Rx Oral Cleansing and Suctioning System, Q2otcHuman OTCSage Products, Inc.MANUFACTURE2014-03-061534620922
19f2d2677e-8bd1-4c1c-8991-ea07009490d5 (view SPL)CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-04-281687889426

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