HIBISTAT ® (0.5% Chlorhexidine Gluconate solution 70% isopropyl alcohol w/w)

Manufacturer: Mölnlycke Health Care US, LLC
Effective date: 2011-04-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:28:31

Label at a glance#

ProductHibistat

Active ingredientChlorhexidine gluconate, Isopropyl alcohol

Label structure8 sections

Dosage and administration

rub hands vigorously with the towelette for about 15 seconds pay particular attention to nails and interdigital spaces no watering or toweling are necessary

Contacts and useful links#

PhoneLabel contact1-800-843-8497

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purposes
Chlorhexidine gluconate solution 0.5% w/w	Antiseptic
Isopropyl alcohol, 70% w/w	Antiseptic

Use

INDICATIONS & USAGE SECTION

Healthcare Personnel Hand Antiseptic helps reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Flammable: keep away from fire or flame.

Do not use

if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
as a patient preoperative skin preparation (especially on the head or face)
in contact with the meninges
in the genital area

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures, or may cause deafness when instilled in the middle ear through perforated eardrums.
if contact occurs in any of these areas, rinse with cold water right away

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

rub hands vigorously with the towelette for about 15 seconds
pay particular attention to nails and interdigital spaces
no watering or toweling are necessary

Inactive ingredients

INACTIVE INGREDIENT SECTION

castor oil, glycerin, purified water

Questions?

OTC - QUESTIONS SECTION

1-800-843-8497

PRINCIPAL DISPLAY PANEL - 5mL Wipe Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0234-0587-17

HIBISTAT^®
(0.5% Chlorhexidine
Gluconate solution
70% isopropyl alcohol w/w)

Healthcare Personnel Hand Antiseptic

HIBISTAT^® provides rapid bactericidal action and has
a persistent antimicrobial effect against a wide range
of microorganisms.

WARNING: For external use only
Flammable: Keep away from fire or flame.
FOR PROFESSIONAL USE ONLY.

MÖLNLYCKE^®
HEALTH CARE

1 Hand Antiseptic Wipe (5mL)

Distributed by Mölnlycke Health Care US, LLC.,
Norcross GA 30092

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
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0234-0587-17	2020-01-31	C162847	48780-1	9d75b9d0-04de-f424-e053-dadaa90a57ce	HIBISTAT ® (0.5% Chlorhexidine Gluconate solution 70% isopropyl alcohol w/w)
0234-0587-27	2020-01-31	C162847	48780-1	9d75b9d0-04de-f424-e053-dadaa90a57ce	HIBISTAT ® (0.5% Chlorhexidine Gluconate solution 70% isopropyl alcohol w/w)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0234-0587-17	Hibistat	5 mL in 1 PACKET	SOLUTION	5	1
0234-0587-17	Hibistat	50 in 1 CARTON	SOLUTION	50	1
0234-0587-27	Hibistat	15 in 1 CARTON	SOLUTION	15	1
0234-0587-27	Hibistat	5 mL in 1 PACKET	SOLUTION	5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0234-0587	HIBISTAT (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [M&OUML;LNLYCKE HEALTH CARE US, LLC]	1	Legacy NDC, 4 package rows	20110701_c6f941d6-527e-4fb8-9581-8532dd84e7a8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0234-0587-17	EA - Each	0234-0587	d70e2392-3ff1-4828-8894-0174ef06e0a8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Chlorhexidine gluconate	ACTIVE INGREDIENT	MOR84MUD8E	1
Isopropyl alcohol	ACTIVE INGREDIENT	ND2M416302	1
Chlorhexidine	ACTIVE MOIETY	R4KO0DY52L	1
Isopropyl alcohol	ACTIVE MOIETY	ND2M416302	1
Castor Oil	INACTIVE INGREDIENT	D5340Y2I9G	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Hibistat
Chlorhexidine gluconate and Isopropyl alcohol
Chlorhexidine gluconate
Chlorhexidine
Isopropyl alcohol
Castor Oil
Glycerin
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0234-0587	0234-0587-17, 0234-0587-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Chlorhexidine gluconate	MOR84MUD8E	ACTIB
Isopropyl alcohol	ND2M416302	ACTIB
Castor Oil	D5340Y2I9G	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

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 2 · 91 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	EMULSION / OPHTHALMIC		32 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	GRANULE, FOR SUSPENSION / ORAL		128 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	SPRAY / NASAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	CAPSULE / ORAL	1.04 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Castor Oil	CASTOR OIL	D5340Y2I9G	TABLET / ORAL		17 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 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
N018300-001	HIBISTAT	CHLORHEXIDINE GLUCONATE	0.5%	SOLUTION / TOPICAL		RLD, RS, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018300-001	HIBISTAT	0.5%	SOLUTION / TOPICAL	RLD, RS, Approved before 1982	`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
21c3470f-a2a8-43a4-8b14-7c57e3dd2287			c6f941d6-527e-4fb8-9581-8532dd84e7a8	2011-04-19	Warnings	Exact identifier spl id: 21c3470f-a2a8-43a4-8b14-7c57e3dd2287 spl set id: c6f941d6-527e-4fb8-9581-8532dd84e7a8

Reported adverse events (FAERS/openFDA)#

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