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)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	spl
1	429390103	EXPORT ONLY	Ava, Inc.	2012-12-16	CHLORHEXIDINE GLUCONATE	TOPICAL	SOLUTION	37d3c63e-8177-482a-8c5a-86ae7f3905c4

original product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	005191322	NDA	Steris Corporation	1999-10-04	CHLORHEXIDINE GLUCONATE	TOPICAL	SOLUTION	NDA019422	6420bbef-a828-4966-906c-164a8d1bbf28
2	523801919	NDA	Aplicare, Inc.	1998-09-01	CHLORHEXIDINE GLUCONATE	TOPICAL	SOLUTION	NDA019422	0beaf7da-fe4b-65cb-e054-00144ff88e88

chlorhexidine gluconate 40 mg/ml topical solution

export only product(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	spl
1	429390102	EXPORT ONLY	Ava, Inc.	2012-12-06	CHLORHEXIDINE GLUCONATE	TOPICAL	SOLUTION	76cfedb3-25ed-4c12-8ebc-b57f029fedaa

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	005191364	Bactoshield	NDA	Steris Corporation	2003-03-27	CHLORHEXIDINE GLUCONATE	TOPICAL	SPONGE	NDA019822	ec19f244-662c-4643-8be0-6d96a0d07801
2	372050595		NDA	Cardinal Health	2012-01-01	CHLORHEXIDINE GLUCONATE	TOPICAL	LIQUID	NDA019125	5577ecbb-cf2c-45e1-a0fb-17df0417eea5

chlorhexidine gluconate 5 mg/ml topical solution

product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	spl
1	518110066	UNAPPROVED DRUG OTHER MARKETING CATEGORY	Hanover Pen Corp Dba Hpc Global	2013-02-01	CHLORHEXIDINE GLUCONATE	TOPICAL	LOTION	eee2947c-07cd-440b-8b98-406b88366f05
2	518110658	UNAPPROVED DRUG OTHER MARKETING CATEGORY	Hanover Pen Corp Dba Hpc Global	2013-02-01	CHLORHEXIDINE GLUCONATE	TOPICAL	LOTION	25f64ae2-fc3a-4fc5-b659-98cb5c6fa199

application(s)

#	id	title	deprecated	applicant	approved	approved drug	in other drug docs
1	ANDA070104	STERI-STAT	True	MATRIX MEDICAL CORP	1986-07-24	ANDA070104_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
2	ANDA071419	BRIAN CARE		SOAPCO INC	1987-12-17	ANDA071419_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
3	ANDA072255	MICRODERM	True	JOHNSON AND JOHNSON MEDICAL INC	1991-04-15	ANDA072255_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
4	ANDA072292	PREVACARE R	True	JOHNSON AND JOHNSON MEDICAL INC	1992-01-28	ANDA072292_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
5	ANDA072295	MICRODERM	True	JOHNSON AND JOHNSON MEDICAL INC	1991-02-28	ANDA072295_001	Chlorhexidine Medicated Liquid Soap
6	ANDA072525	CHLORHEXIDINE GLUCONATE		BECTON DICKINSON AND CO	1989-10-24	ANDA072525_001	Chlorhexidine Medicated Liquid Soap
7	ANDA073416	E-Z SCRUB	True	BECTON DICKINSON SURGICAL SYSTEM	2000-03-14	ANDA073416_001	Chlorhexidine Medicated Liquid Soap
8	NDA017768	HIBICLENS		MOLNLYCKE HEALTH CARE		NDA017768_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
9	NDA018300	HIBISTAT		MOLNLYCKE HEALTH CARE		NDA018300_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
10	NDA018423	HIBICLENS	True	MOLNLYCKE HEALTH CARE		NDA018423_001	Chlorhexidine Medicated Liquid Soap
11	NDA019125	EXIDINE		XTTRIUM LABORATORIES INC	1984-12-24	NDA019125_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
12	NDA019258	CHG SCRUB		ECOLAB INC	1986-07-22	NDA019258_001, NDA019258_002	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
13	NDA019421	EXIDINE	True	XTTRIUM LABORATORIES INC	1985-12-17	NDA019421_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
14	NDA019422	EXIDINE		XTTRIUM LABORATORIES INC	1985-12-17	NDA019422_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap
15	NDA019490	CHLORHEXIDINE GLUCONATE	True	KENDALL CO	1987-03-27	NDA019490_001	Chlorhexidine Medicated Liquid Soap
16	NDA019793	PHARMASEAL SCRUB CARE		CAREFUSION 213 LLC	1988-12-02	NDA019793_001	Chlorhexidine Medicated Liquid Soap
17	NDA019822	BIOSCRUB		KW GRIFFEN CO	1989-03-31	NDA019822_001	Chlorhexidine Medicated Liquid Soap
18	NDA020111	DYNA-HEX		BAJAJ MECICAL LLC	1997-09-11	NDA020111_001	Chlorhexidine Medicated Pad Chlorhexidine Medicated Liquid Soap

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	ANDA070104_001	discontinued	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SOLUTION	False	1986-07-24	STERI-STAT
2	ANDA071419_001	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SOLUTION	False	1987-12-17	BRIAN CARE
3	ANDA072255_001	discontinued	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SOLUTION	False	1991-04-15	MICRODERM
4	ANDA072292_001	discontinued	CHLORHEXIDINE GLUCONATE (0.5%)	TOPICAL	SOLUTION	False	1992-01-28	PREVACARE R
5	ANDA072295_001	discontinued	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	False	1991-02-28	MICRODERM
6	ANDA072525_001	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	False	1989-10-24	CHLORHEXIDINE GLUCONATE
7	ANDA073416_001	discontinued	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	False	2000-03-14	E-Z SCRUB
8	NDA017768_001	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SOLUTION	True		HIBICLENS
9	NDA018300_001	OTC	CHLORHEXIDINE GLUCONATE (0.5%)	TOPICAL	SOLUTION	True		HIBISTAT
10	NDA018423_001	discontinued	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	False		HIBICLENS
11	NDA019125_001	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SOLUTION	False	1984-12-24	EXIDINE
12	NDA019258_001	OTC	CHLORHEXIDINE GLUCONATE (2%)	TOPICAL	SOLUTION	False	1986-07-22	CHG SCRUB
13	NDA019258_002	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SOLUTION	False	1986-07-22	CHG SCRUB
14	NDA019421_001	discontinued	CHLORHEXIDINE GLUCONATE (2.5%)	TOPICAL	SOLUTION	False	1985-12-17	EXIDINE
15	NDA019422_001	OTC	CHLORHEXIDINE GLUCONATE (2%)	TOPICAL	SOLUTION	True	1985-12-17	EXIDINE
16	NDA019490_001	discontinued	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	False	1987-03-27	CHLORHEXIDINE GLUCONATE
17	NDA019793_001	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	True	1988-12-02	PHARMASEAL SCRUB CARE
18	NDA019822_001	OTC	CHLORHEXIDINE GLUCONATE (4%)	TOPICAL	SPONGE	False	1989-03-31	BIOSCRUB
19	NDA020111_001	OTC	CHLORHEXIDINE GLUCONATE (0.75%)	TOPICAL	SOLUTION	False	1997-09-11	DYNA-HEX

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	0beaf7da-fe4b-65cb-e054-00144ff88e88 (view SPL)	Drug Facts	otc	Human OTC	Aplicare, Inc.		2015-08-12	6	523801919
2	25f64ae2-fc3a-4fc5-b659-98cb5c6fa199 (view SPL)	Drug Facts	otc	Human OTC	Hanover Pen Corp Dba Hpc Global	label, manufacture, repack	2013-02-01	1	518110658
3	37d3c63e-8177-482a-8c5a-86ae7f3905c4 (view SPL)	Antiseptic Skin Cleanser(Chlorhexidine Gluconate 2% Topical Solution, USP)	otc	Human OTC	Ava, Inc.	manufacture	2012-12-16	1	429390103
4	5577ecbb-cf2c-45e1-a0fb-17df0417eea5 (view SPL)	Drug Facts	prescription	Human Prescription	Cardinal Health	manufacture	2012-09-26	2	372050595
5	6420bbef-a828-4966-906c-164a8d1bbf28 (view SPL)	Bactoshield CHG 2% Chlorhexidine Gluconate 2% Solution	otc	Human OTC	Steris Corporation	MANUFACTURE	2014-06-05	5	005191322
6	6a77ef12-825d-4b37-8c1c-6540bf7970c4 (view SPL)	Drug Facts	otc	Human OTC	Aplicare, Inc.	repack	2010-06-09	3	523801274
7	6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63 (view SPL)	Drug Facts	otc	Human OTC	Puretek Corporation	manufacture	2014-01-27	3	001161021
8	76cfedb3-25ed-4c12-8ebc-b57f029fedaa (view SPL)	Antiseptic Skin Cleanser(Chlorhexidine Gluconate 4% Solution)	otc	Human OTC	Ava, Inc.	manufacture	2012-12-06	1	429390102
9	cd223ce2-b307-4202-ae89-dd96c78c5d57 (view SPL)	Bactoshield CHG Chlorhexidine Gluconate Solution	otc	Human OTC	Steris Corporation	MANUFACTURE	2013-08-16	4	005191344
10	dfdaa646-0ef5-4433-b8d3-39ec139827b9 (view SPL)	Drug Facts	otc	Human OTC	Preferred Plus (Kinray)	manufacture	2013-08-01	2	617150072
11	ec19f244-662c-4643-8be0-6d96a0d07801 (view SPL)	Bactoshield CHG 4% Surgical Scrub	otc	Human OTC	Steris Corporation	MANUFACTURE	2014-03-12	2	005191364
12	eee2947c-07cd-440b-8b98-406b88366f05 (view SPL)	Drug Facts	otc	Human OTC	Hanover Pen Corp Dba Hpc Global	label, manufacture, repack	2013-02-01	1	518110066

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