Hibiclens

Manufacturer
Molnlycke Health Care
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:48:24

Label at a glance#

ProductHibiclens
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure14 sections

Indications and uses

antimicrobial skin cleanser helps to reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare peronnel handwash

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly. surgical hand scrub . Wet hands and forearms with water. Scrub for 3 minutes with ab...

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution 4.0% w/v

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • antimicrobial skin cleanser helps to reduce bacteria that potentially can cause disease
  • for skin wound and general skin cleansing
  • surgical hand scrub
  • healthcare peronnel handwash

WARNINGS SECTION

For external use only

Allergy alert:

WARNINGS SECTION

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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • 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 permitted to enter and remain in the eye 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
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general cleansing of large body areas should not be done except when advised by a health care provider

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 or infants under 2 months of age. These products may cause irritation or chemical burns.
  • skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly.
  • surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
  • healthcare personnel handwash. Wet hand with water. Dispense about 5mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Other information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40

Questions?

OTC - QUESTIONS SECTION

1-800-843-8497

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hibiclens 4oz Bottle PDPHibiclens 4oz Bottle PDPHibiclens 4oz Carton PDPHibiclens 4oz Carton PDPHibiclens 8oz bottle PDPHibiclens 8oz bottle PDPHibiclens 8oz Carton PDPHibiclens 8oz Carton PDPHibiclens 16oz Bottle PDPHibiclens 16oz Bottle PDPHibiclens 16oz Carton PDPHibiclens 16oz Carton PDPHibiclens 32oz PDPHibiclens 32oz PDPHibiclens 1 gallon PDPHibiclens 1 gallon PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN13
834167HIBICLENS 4 % Medicated Liquid SoapPSN13
834167chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens]SBD13
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD13
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY13
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY13
834167Hibiclens 4 % Medicated Liquid SoapSY13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0234-0575-04Hibiclens118 mL in 1 BOTTLESOLUTION11813
0234-0575-08Hibiclens236 mL in 1 BOTTLESOLUTION23613
0234-0575-16Hibiclens473 mL in 1 BOTTLESOLUTION47313
0234-0575-32Hibiclens946 mL in 1 BOTTLESOLUTION94613
0234-0575-91Hibiclens3790 mL in 1 BOTTLESOLUTION379013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0234-0575HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE]13Current NDC, Legacy NDC, 5 package rows20241225_4275eb53-1a7e-4a91-aac1-1085f40fac88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0234-0575-04ML - Milliliter0234-05752c7f09fc-94c5-4fc5-b48c-71188619df1812012-07-24
0234-0575-08ML - Milliliter0234-05759eea668e-5fde-456f-a7ee-3251bffca1c512012-07-24
0234-0575-16ML - Milliliter0234-05750cc2b373-1d80-4637-99b6-75fb80ba95a212012-07-24
0234-0575-17ML - Milliliter0234-057594926e3b-31c8-456c-8dea-5c4ed2b69cdd12012-07-24
0234-0575-32ML - Milliliter0234-0575588c6c29-dfd9-40e4-ba05-8544184bdfca12012-07-24
0234-0575-40ML - Milliliter0234-0575b49c8b95-df57-4aea-b30b-e4892191a03712017-11-06
0234-0575-41ML - Milliliter0234-05752d7ae4b3-648f-4ab7-bb82-dca7abcd265c12019-12-10
0234-0575-80ML - Milliliter0234-0575d0508c6d-a36c-46d0-be06-7f8f2d689bb712026-04-20
0234-0575-91ML - Milliliter0234-05757ea5bf35-011c-4299-a7e2-29b0c6ecbb6e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E4
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA4
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163024
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8W4
POLOXAMER 237INACTIVE INGREDIENTJT3U72U71K4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0234-05750234-0575-04, 0234-0575-08, 0234-0575-16, 0234-0575-32, 0234-0575-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 1 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
24 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
24 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii+route
24 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii+dosage form
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+dosage form
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
6 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017768-001HIBICLENSCHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICALRLD, 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982f41ea6bd6efb…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HibiclensCHLORHEXIDINE GLUCONATEMolnlycke Health Care29b547bf-c08e-14c2-e054-00144ff88e882024-12-23WarningsExact identifier
ndc (product): 0234-0575
HibiclensCHLORHEXIDINE GLUCONATEMolnlycke Health Care4275eb53-1a7e-4a91-aac1-1085f40fac882024-12-23WarningsExact identifier
ndc (package): 0234-0575-91
ndc (package): 0234-0575-32
ndc (package): 0234-0575-16
ndc (package): 0234-0575-08
ndc (package): 0234-0575-04
ndc (product): 0234-0575
ndc11 (package): 00234057532
ndc11 (package): 00234057504
ndc11 (package): 00234057516
ndc11 (package): 00234057591
ndc11 (package): 00234057508
spl id: 29f3a722-b70e-15f6-e063-6294a90a474f
spl set id: 4275eb53-1a7e-4a91-aac1-1085f40fac88
HibiclensCHLORHEXIDINE GLUCONATEMolnlycke Health Care8b37a721-79bb-4051-95a7-fcb4edebfcb72024-12-23WarningsExact identifier
ndc (product): 0234-0575

Reported adverse events (FAERS/openFDA)#

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