Chlorhexidine Gluconate Solution 0.75% Antiseptic

Manufacturer: Bajaj Medical, LLC
Effective date: 2022-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-05-31 23:52:38

Label at a glance#

ProductChlorhexidine Gluconate Solution 0.75% Antiseptic

Active ingredientCHLORHEXIDINE GLUCONATE

Label structure9 sections

Dosage and administration

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds rinse and dry thoroughly

Storage and handling

store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Contacts and useful links#

PhoneLabel contact1-800-581-2528

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution, 0.75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

This product may cause a severe allergic reaction.

Symptoms may include:

wheezing/difficulty breathing
shock
facial swelling
hives
rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to chlorhexidine gluconate or any other ingredient in this product

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
if solution should contact these areas, rinse out promptly and thoroughly with water
do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

DOSAGE & ADMINISTRATION SECTION

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
rinse and dry thoroughly

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-581-2528, 24 hours a day, 7 days a week

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

4 fl oz (118 mL)

NDC 61037-414-01

MADE IN THE USA

FDA APPROVED

4ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

8 fl oz (236 mL)

NDC 61037-414-02

MADE IN THE USA

FDA APPROVED

8ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

16 fl oz (473 mL)

NDC 61037-414-05

MADE IN THE USA

FDA APPROVED

16ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

32 fl oz (946 mL)

NDC 61037-414-06

MADE IN THE USA

FDA APPROVED

32ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

128 fl oz (3785 mL)

NDC 61037-414-07

MADE IN THE USA

FDA APPROVED

128ozlbl

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

8 fl oz (236 mL)

NDC 61037-414-03

MADE IN THE USA

FDA APPROVED

8ozlblclr

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

8 fl oz (236 mL)

NDC 61037-414-04

MADE IN THE USA

FDA APPROVED

8ozlblwht

Chlorhexidine Gluconate Solution

0.75%

ANTISEPTIC

FOR EXTERNAL USE ONLY

Bajaj Medical

Chicago IL 60609

40.6 fl oz (1.2 L)

NDC 61037-414-08

MADE IN THE USA

FDA APPROVED

1200mllbl

STORAGE AND HANDLING SECTION

Keep from freezing.

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORHEXIDINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61037-414-01	Chlorhexidine Gluconate Solution 0.75% Antiseptic	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	15
61037-414-02	Chlorhexidine Gluconate Solution 0.75% Antiseptic	236 mL in 1 BOTTLE, PLASTIC	SOLUTION	236	15
61037-414-03	Chlorhexidine Gluconate Solution 0.75% Antiseptic	236 mL in 1 BOTTLE, PUMP	SOLUTION	236	15
61037-414-04	Chlorhexidine Gluconate Solution 0.75% Antiseptic	236 mL in 1 BOTTLE, PUMP	SOLUTION	236	15
61037-414-05	Chlorhexidine Gluconate Solution 0.75% Antiseptic	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473	15
61037-414-06	Chlorhexidine Gluconate Solution 0.75% Antiseptic	946 mL in 1 BOTTLE, PLASTIC	SOLUTION	946	15
61037-414-07	Chlorhexidine Gluconate Solution 0.75% Antiseptic	3785 mL in 1 JUG	SOLUTION	3785	15
61037-414-08	Chlorhexidine Gluconate Solution 0.75% Antiseptic	1200 mL in 1 BOTTLE, DISPENSING	SOLUTION	1200	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61037-414	CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC SOLUTION [BAJAJ MEDICAL, LLC]	15	Current NDC, Legacy NDC, 8 package rows	20221227_014a5f36-0396-498b-901f-9a86df4e11fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	2
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	2
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	2
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	2
LAURAMINE OXIDE	INACTIVE INGREDIENT	4F6FC4MI8W	2
RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE	INACTIVE INGREDIENT	93OU7D1C3U	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Chlorhexidine Gluconate Solution 0.75% Antiseptic
COCO DIETHANOLAMIDE
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE
WATER
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 5
FD&C RED NO. 4
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61037-414	61037-414-01, 61037-414-02, 61037-414-05, 61037-414-06, 61037-414-07, 61037-414-03, 61037-414-04, 61037-414-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCO DIETHANOLAMIDE	92005F972D	IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	8136Y38GY5	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LAURAMINE OXIDE	4F6FC4MI8W	IACT
RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE	93OU7D1C3U	IACT
WATER	059QF0KO0R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C RED NO. 4	X3W0AM1JLX	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
LAURAMINE OXIDE	LAURAMINE OXIDE	4F6FC4MI8W	SOLUTION / TOPICAL	3.5 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020111-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL			1997-09-11

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020111-001	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION / TOPICAL	1997-09-11	`f41ea6bd6efb…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorhexidine Gluconate Solution 0.75% Antiseptic	CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC	Bajaj Medical, LLC	014a5f36-0396-498b-901f-9a86df4e11fe	2022-12-26	Warnings	Exact identifier ndc (package): 61037-414-08 ndc (package): 61037-414-05 ndc (package): 61037-414-01 ndc (package): 61037-414-07 ndc (package): 61037-414-06 ndc (package): 61037-414-03 ndc (package): 61037-414-04 ndc (package): 61037-414-02 ndc (product): 61037-414 ndc11 (package): 61037041405 ndc11 (package): 61037041407 ndc11 (package): 61037041403 ndc11 (package): 61037041408 ndc11 (package): 61037041406 ndc11 (package): 61037041404 ndc11 (package): 61037041401 ndc11 (package): 61037041402 spl id: f0b7b337-be39-2e5f-e053-2995a90a3c8c spl set id: 014a5f36-0396-498b-901f-9a86df4e11fe

Reported adverse events (FAERS/openFDA)#

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