FDA.reportPublic FDA data

Antibacterial Foaming Skin Cleanser

Product NDC
65601-709
Requested package NDC
65601-709-55
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5cb1df5-1e13-4a0b-939e-071c577bcf15Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltd.e5cb1df5-1e13-4a0b-939e-071c577bcf152026-02-26WarningsExact identifier
ndc (package): 65601-709-55
ndc (product): 65601-709
ndc11 (package): 65601070955

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
65601-709-5565601070955208000 mL in 1 DRUM (65601-709-55) 208000 ml2017-07-190000-00-00NoNoCurrent