FDA.reportPublic FDA data

E2 Antibacterial Foaming Skin Cleanser

Product NDC
65601-817
11-digit product format
656010817
Labeler code
65601
Product ID
65601-817_50a1cee8-875b-c0c1-e063-6394a90ac56c
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
2014-01-17
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65601-81765601-817-03DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
E2 Antibacterial Foaming Skin Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 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
aa7c24bb-cc66-3081-e053-2a95a90ada03Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-817-032024-01-30C16284748780-11030e364-fea3-111a-e063-dadaa90a10e2E2 Antibacterial Foaming Skin Cleanser
65601-817-042024-01-30C16284748780-11030e364-fea3-111a-e063-dadaa90a10e2E2 Antibacterial Foaming Skin Cleanser
65601-817-292024-01-30C16284748780-11030e364-fea3-111a-e063-dadaa90a10e2E2 Antibacterial Foaming Skin Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65601-817-03E2 Antibacterial Foaming Skin Cleanser750 mL in 1 BOTTLESOAP7508
65601-817-04E2 Antibacterial Foaming Skin Cleanser3780 mL in 1 JUGSOAP37808
65601-817-29E2 Antibacterial Foaming Skin Cleanser1000 mL in 1 BAGSOAP10008
65601-817-55E2 Antibacterial Foaming Skin Cleanser208000 mL in 1 DRUMSOAP2080008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65601-817E2 ANTIBACTERIAL FOAMING SKIN CLEANSER (BENZALKONIUM CHLORIDE) SOAP [BETCO CORPORATION, LTD.]7Current NDC, Legacy NDC, 4 package rows20250322_aa7c24bb-cc66-3081-e053-2a95a90ada03.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
E2 Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltd.aa7c24bb-cc66-3081-e053-2a95a90ada032026-04-29WarningsExact identifier
ndc (product): 65601-817

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNaa7c24bb-cc66-3081-e053-2a95a90ada038
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDaa7c24bb-cc66-3081-e053-2a95a90ada038
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYaa7c24bb-cc66-3081-e053-2a95a90ada038
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYaa7c24bb-cc66-3081-e053-2a95a90ada038

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65601-817-0365601081703750 mL in 1 BOTTLE750 mlHistorical
65601-817-04656010817043780 mL in 1 JUG (65601-817-04) 3780 ml2014-01-170000-00-00NoNoCurrent
65601-817-29656010817291000 mL in 1 BAG (65601-817-29) 1000 ml2014-01-170000-00-00NoNoCurrent
65601-817-5565601081755208000 mL in 1 DRUM (65601-817-55) 208000 ml2014-01-17NoNoCurrent