FDA.reportPublic FDA data

Antibacterial

Product NDC
68599-5501
11-digit product format
685995501
Labeler code
68599
Product ID
68599-5501_24381ab3-73da-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
58892abf-e0b9-83d9-e053-2a91aa0ad035Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68599-5501-12020-03-28McKesson Antibacterial Soap
68599-5501-22020-03-28McKesson Antibacterial Soap
68599-5501-32020-03-28McKesson Antibacterial Soap
68599-5501-42020-03-28McKesson Antibacterial Soap
68599-5501-12020-01-31McKesson Antibacterial Soap
68599-5501-22020-01-31McKesson Antibacterial Soap
68599-5501-32020-01-31McKesson Antibacterial Soap
68599-5501-42020-01-31McKesson Antibacterial Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5501-1Antibacterial3785 mL in 1 BOTTLELIQUID37854
68599-5501-2Antibacterial1000 mL in 1 BOTTLELIQUID10004
68599-5501-3Antibacterial237 mL in 1 BOTTLE, DISPENSINGLIQUID2374
68599-5501-4Antibacterial532 mL in 1 BOTTLE, DISPENSINGLIQUID5324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5501ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [MCKESSON]4Current NDC, Legacy NDC, 4 package rows20241013_58892abf-e0b9-83d9-e053-2a91aa0ad035.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 47 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.479beac0-16bc-a88c-e063-6394a90a42f52026-01-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Silicone Case 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.478b0ba2-d8ce-8101-e063-6294a90a64642026-01-03WarningsExact identifier
application number: M003
CASA COLADA SAPRY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47679265-2ec3-4c62-e063-6294a90a60b62026-01-02WarningsExact identifier
application number: M003
Fiji Punch Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4767ed4b-ebec-ca75-e063-6294a90a82d32026-01-02WarningsExact identifier
application number: M003
VILLA VANILLA HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd47682ec1-5479-2ea5-e063-6394a90aa1922026-01-02WarningsExact identifier
application number: M003
Wipex Sanitizing WipesBENZALKONIUM CHLORIDEUnico476d7085-82d8-5e84-e063-6394a90a64482026-01-02WarningsExact identifier
application number: M003
Alcohol PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.74dc43d1-2aba-4f8a-876a-ce712ad37eeb2026-01-01WarningsExact identifier
application number: M003
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
application number: M003
Iodine Prep Pad AntisepticPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.0fdded64-4e89-d28c-e063-6394a90a7b8f2026-01-01WarningsExact identifier
application number: M003
OP First Aid Series Alcohol Prep PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4555-358e-e053-2995a90ae0ff2026-01-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAstera International LLCa5189240-19ce-7715-e053-2995a90ad0432025-12-31WarningsExact identifier
application number: M003
Water Jel Hydrogen PeroxideHYDROGEN PEROXIDEWater-Jel Technologiesf508c3cb-e162-4d11-9513-ff44918f82c02025-12-31WarningsExact identifier
application number: M003
HEB 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLHEB Grocery Companye8dd7f84-3690-4ab3-a21f-43bf66984f4b2025-12-30WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
application number: M003
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
application number: M003
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
application number: M003
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039026benzethonium chloride 0.13 % Medicated Liquid SoapPSN58892abf-e0b9-83d9-e053-2a91aa0ad0354
1039026benzethonium chloride 1.3 MG/ML Medicated Liquid SoapSCD58892abf-e0b9-83d9-e053-2a91aa0ad0354
1039026benzethonium chloride 0.13 % Medicated Liquid SoapSY58892abf-e0b9-83d9-e053-2a91aa0ad0354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-5501-1685995501013785 mL in 1 BOTTLE (68599-5501-1) 3785 ml2017-09-290000-00-00NoNoCurrent
68599-5501-2685995501021000 mL in 1 BOTTLE (68599-5501-2) 1000 ml2017-09-290000-00-00NoNoCurrent
68599-5501-368599550103237 mL in 1 BOTTLE, DISPENSING (68599-5501-3) 237 ml2017-09-290000-00-00NoNoCurrent
68599-5501-468599550104532 mL in 1 BOTTLE, DISPENSING (68599-5501-4) 532 ml2017-09-290000-00-00NoNoCurrent