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 88 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003
Easy Care Hand SanitizerALCOHOLGFA Production (Xiamen) Co., Ltd.c7058806-ad4e-6d5f-e053-2a95a90a35e82025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Rejoice International Corp.04fd3bbe-1729-a748-e063-6394a90a96552025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Rejoice International Corp.04fd9665-a6b3-678a-e063-6294a90a60a52025-01-27WarningsExact identifier
application number: M003
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
application number: M003
Germstar Premium Hand SanitizerETHYL ALCOHOLSoaptronic LLC489652af-7333-628a-e054-00144ff8d46c2025-01-24WarningsExact identifier
application number: M003
Little Buddy in a Little TubbyHAND SANITIZING TOWELETTESContinental Research Corpf4fac964-4a27-335d-e053-2a95a90ac4eb2025-01-23WarningsExact identifier
application number: M003
PHARMACYS PRESCRIPTION 8OZ HAND SANITIZERALCOHOLAmerican Consumer Products Corp7a048607-f4c3-6724-e053-2a91aa0ab6f22025-01-23WarningsExact identifier
application number: M003
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERAALCOHOLAmerican Consumer Products Corpa8f00148-b8fa-6c4f-e053-2995a90ac5e22025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa9ca8aaa-ea76-7eb5-e053-2995a90adef92025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa8c6ef84-b072-72ee-e053-2995a90aa1112025-01-23WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Rejoice International Corp.052031f9-5206-c1bc-e063-6394a90ab0f22025-01-23WarningsExact 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