FDA.reportPublic FDA data

Antibacterial

Product NDC
68599-5502
Requested package NDC
68599-5502-2
11-digit product format
685995502
Labeler code
68599
Product ID
68599-5502_24381ab3-73eb-f89a-e063-6394a90ab30a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
McKesson
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-29
Substance
BENZETHONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039026Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
588a89cd-9481-6163-e053-2991aa0a9e3dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68599-5502-12020-03-28McKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-22020-03-28McKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-32020-03-28McKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-12020-01-31McKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-22020-01-31McKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-32020-01-31McKESSON FOAMING ANTIBACTERIAL SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5502-1Antibacterial251 mL in 1 BOTTLE, PUMPLIQUID2513
68599-5502-2Antibacterial1000 mL in 1 BOTTLELIQUID10003
68599-5502-3Antibacterial532 mL in 1 BOTTLE, PUMPLIQUID5323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5502ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [MCKESSON]3Current NDC, Legacy NDC, 3 package rows20241013_588a89cd-9481-6163-e053-2991aa0a9e3d.zip

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 97 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039026benzethonium chloride 0.13 % Medicated Liquid SoapPSN588a89cd-9481-6163-e053-2991aa0a9e3d3
1039026benzethonium chloride 1.3 MG/ML Medicated Liquid SoapSCD588a89cd-9481-6163-e053-2991aa0a9e3d3
1039026benzethonium chloride 0.13 % Medicated Liquid SoapSY588a89cd-9481-6163-e053-2991aa0a9e3d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-5502-2685995502021000 mL in 1 BOTTLE (68599-5502-2) 1000 ml2017-09-290000-00-00NoNoCurrent