Is there a generic for Chlorhexidine gluconate?

Yes. The FDA Orange Book lists 16 approved generic (ANDA) applications for Chlorhexidine gluconate, referencing the brand READYPREP CHG. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chlorhexidine gluconate?

READYPREP CHG (NDA 207964, MEDLINE INDUSTRIES) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Chlorhexidine gluconate?

The Orange Book lists 2 patents against Chlorhexidine gluconate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Chlorhexidine gluconate are approved?

Chlorhexidine gluconate is approved in the following dosage forms: aerosol, metered, cloth, solution, sponge, tablet.

FDA Orange Book · active-ingredient family

Chlorhexidine gluconate

Chlorhexidine gluconate: 16 brands, 16 generics; first approved Dec 24, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 16 ANDA applications approved.

Earliest patent expiry Apr 25, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 25, 2026

3 mo ago

Originator applications

Brand (NDA) products

READYPREP CHGRLDRS

MEDLINE INDUSTRIESNDA 2079642018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CLOTH	TOPICAL	OTC	—

CHLORHEXIDINE GLUCONATERLDRS

SAGE PRODSNDA 0216692005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CLOTH	TOPICAL	OTC	—

PERIOCHIPRLD

DEXCEL PHARMANDA 0207741998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	DENTAL	Discontinued	—

PERIDEXRLDRS

SOLVENTUMNDA 0190281986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

DYNA-HEX 2RLDRS

XTTRIUMNDA 0194221985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	—

EXIDINERLDRS

XTTRIUMNDA 0191271984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	AEROSOL, METERED	TOPICAL	OTC	—

HIBICLENSRLDRS

MOLNLYCKE HLTHNDA 017768—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	OTC	—

HIBISTATRLDRS

MOLNLYCKE HLTHNDA 018300—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION	TOPICAL	OTC	—

HIBICLENSRLD

MOLNLYCKE HLTHNDA 018423—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPONGE	TOPICAL	Discontinued	—

CHLORHEXIDINE GLUCONATE

BAJAJNDA 0201111997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75%	SOLUTION	TOPICAL	OTC	—

BIOSCRUB

GRIFFENNDA 0198221989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SPONGE	TOPICAL	OTC	—

PHARMASEAL SCRUB CARE

CAREFUSION 2200NDA 0197931988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SPONGE	TOPICAL	Discontinued	—

CHLORHEXIDINE GLUCONATE

KENDALL ILNDA 0194901987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SPONGE	TOPICAL	Discontinued	—

CHG SCRUB

ECOLABNDA 01925819862 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	—
4%	SOLUTION	TOPICAL	OTC	—

EXIDINE

XTTRIUMNDA 0194211985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	SOLUTION	TOPICAL	Discontinued	—

DYNA-HEX 4

XTTRIUMNDA 0191251984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	OTC	—

Abbreviated applications

Generic (ANDA) products (16)

PERIOGARD

COLGATE-PALMOLIVE COANDA 2032122016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

CHLORHEXIDINE GLUCONATE

PHARMOBEDIENTANDA 0777892009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

PAROEX

SUNSTAR AMERICASANDA 0764342005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Discontinued	—

CHLORHEXIDINE GLUCONATE

CHARTWELL RXANDA 0750062004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

CHLORHEXIDINE GLUCONATE

BAJAJANDA 0755612000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

E-Z SCRUB

BECTON DICKINSONANDA 0734162000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SPONGE	TOPICAL	Discontinued	—

CHLORHEXIDINE GLUCONATE

SCIEGEN PHARMSANDA 0743561996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Discontinued	—

CHLORHEXIDINE GLUCONATE

LYNEANDA 0742911995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

CHLORHEXIDINE GLUCONATE

PHARM ASSOCANDA 0745221995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Rx	AT

PERIOGARD

COLGATE PALMOLIVE COANDA 0736951994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.12%	SOLUTION	DENTAL	Discontinued	—

PREVACARE R

J AND JANDA 0722921992

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION	TOPICAL	Discontinued	—

MICRODERM

J AND JANDA 0722551991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Discontinued	—

MICRODERM

J AND JANDA 0722951991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SPONGE	TOPICAL	Discontinued	—

CHLORHEXIDINE GLUCONATERS

BECTON DICKINSONANDA 0725251989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SPONGE	TOPICAL	OTC	—

BRIAN CARE

SOAPCOANDA 0714191987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Discontinued	—

STERI-STAT

MATRIX MEDCLANDA 0701041986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7427574	Apr 25, 2026	3 mo ago	Product
7935093	Oct 02, 2027	in 1 yr 3 mo	ProductU-1022

FDA approval span

Approval history

First approval

Dec 24, 1984

42 yr 2 mo ago

Most recent approval

Nov 20, 2018

7 yr 9 mo ago

Approvals span 1984–2018 across 32 FDA applications.

Brand (NDA) 1650%

Generic (ANDA) 1650%

Chlorhexidine gluconate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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