Antiseptic Skin Cleanser

Product NDC
68599-5401
11-digit product format
685995401
Labeler code
68599
Product ID
68599-5401_2bd8fbd8-918a-0617-e063-6294a90a6c7e
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORHEXIDINE GLUCONATE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
McKesson Medical-Surgical
Application
NDA019125
Marketing category
NDA
Marketing start
2017-06-01
Substance
CHLORHEXIDINE GLUCONATE
Active strength
4 g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019125-001DYNA-HEX 4CHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICAL1984-12-24

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEMcKesson Medical-Surgical626d7aa9-b8da-4254-9c57-9007ed4290d42025-01-16WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings 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 if you are allergic to chlorhexidine gluconate or any other ingredients in this product in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product 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 solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin Stop use and ask doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic Skin Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui211365

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5401-0Antiseptic Skin Cleanser4 in 1 CASESOLUTION410
68599-5401-1Antiseptic Skin Cleanser48 in 1 CASESOLUTION4810
68599-5401-2Antiseptic Skin Cleanser118 mL in 1 BOTTLESOLUTION11810
68599-5401-3Antiseptic Skin Cleanser237 mL in 1 BOTTLESOLUTION23710
68599-5401-4Antiseptic Skin Cleanser473 mL in 1 BOTTLESOLUTION47310
68599-5401-5Antiseptic Skin Cleanser946 mL in 1 BOTTLESOLUTION94610
68599-5401-6Antiseptic Skin Cleanser3800 mL in 1 BOTTLESOLUTION380010
68599-5401-7Antiseptic Skin Cleanser24 in 1 CASESOLUTION2410
68599-5401-8Antiseptic Skin Cleanser12 in 1 CASESOLUTION1210
68599-5401-9Antiseptic Skin Cleanser12 in 1 CASESOLUTION1210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5401ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE) SOLUTION [MCKESSON MEDICAL-SURGICAL]10Current NDC, Legacy NDC, 10 package rows20250119_626d7aa9-b8da-4254-9c57-9007ed4290d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN626d7aa9-b8da-4254-9c57-9007ed4290d410
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD626d7aa9-b8da-4254-9c57-9007ed4290d410
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY626d7aa9-b8da-4254-9c57-9007ed4290d410
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY626d7aa9-b8da-4254-9c57-9007ed4290d410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-5401-0685995401004 BOTTLE in 1 CASE (68599-5401-0) / 3800 mL in 1 BOTTLE (68599-5401-6) 4 bottle2017-06-010000-00-00NoNoCurrent
68599-5401-16859954010148 BOTTLE in 1 CASE (68599-5401-1) / 118 mL in 1 BOTTLE (68599-5401-2) 48 bottle2017-06-012026-08-31NoNoCurrent
68599-5401-268599540102118 mL in 1 BOTTLE118 mlHistorical
68599-5401-368599540103237 mL in 1 BOTTLE237 mlHistorical
68599-5401-468599540104473 mL in 1 BOTTLE473 mlHistorical
68599-5401-568599540105946 mL in 1 BOTTLE946 mlHistorical
68599-5401-6685995401063800 mL in 1 BOTTLE3800 mlHistorical
68599-5401-76859954010724 BOTTLE in 1 CASE (68599-5401-7) / 237 mL in 1 BOTTLE (68599-5401-3) 24 bottle2017-06-012026-10-31NoNoCurrent
68599-5401-86859954010812 BOTTLE in 1 CASE (68599-5401-8) / 473 mL in 1 BOTTLE (68599-5401-4) 12 bottle2017-06-012027-01-31NoNoCurrent
68599-5401-96859954010912 BOTTLE in 1 CASE (68599-5401-9) / 946 mL in 1 BOTTLE (68599-5401-5) 12 bottle2017-06-012026-08-31NoNoCurrent