FDA.reportPublic FDA data

Antibacterial Foaming Skin Cleanser

Product NDC
65601-709
11-digit product format
656010709
Labeler code
65601
Product ID
65601-709_4bbbcd5e-a4e8-d5cc-e063-6294a90a07ae
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Betco Corporation, Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-19
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-709-042024-01-30C16284748780-11030e365-213d-111a-e063-dadaa90a10e2Antibacterial Foaming Skin Cleanser
65601-709-292024-01-30C16284748780-11030e365-213d-111a-e063-dadaa90a10e2Antibacterial Foaming Skin Cleanser
65601-709-552024-01-30C16284748780-11030e365-213d-111a-e063-dadaa90a10e2Antibacterial Foaming Skin Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65601-709-04Antibacterial Foaming Skin Cleanser3780 mL in 1 BOTTLE, PLASTICSOAP378010
65601-709-29Antibacterial Foaming Skin Cleanser1000 mL in 1 BAGSOAP100010
65601-709-55Antibacterial Foaming Skin Cleanser208000 mL in 1 DRUMSOAP20800010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65601-709ANTIBACTERIAL FOAMING SKIN CLEANSER (BENZALKONIUM CHLORIDE) SOAP [BETCO CORPORATION, LTD.]7Current NDC, Legacy NDC, 3 package rows20240704_e5cb1df5-1e13-4a0b-939e-071c577bcf15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNe5cb1df5-1e13-4a0b-939e-071c577bcf1510
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDe5cb1df5-1e13-4a0b-939e-071c577bcf1510
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYe5cb1df5-1e13-4a0b-939e-071c577bcf1510
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYe5cb1df5-1e13-4a0b-939e-071c577bcf1510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65601-709-04656010709043780 mL in 1 BOTTLE, PLASTIC (65601-709-04) 3780 ml2017-07-190000-00-00NoNoCurrent
65601-709-29656010709291000 mL in 1 BAG (65601-709-29) 1000 ml2017-07-190000-00-00NoNoCurrent
65601-709-5565601070955208000 mL in 1 DRUM (65601-709-55) 208000 ml2017-07-190000-00-00NoNoCurrent