FDA.reportPublic FDA data

Antibacterial Hand Wash

Product NDC
69790-488
Requested package NDC
69790-488-08
11-digit product format
697900488
Labeler code
69790
Product ID
69790-488_4b09a24b-e82c-d0ea-e063-6294a90a5ea9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride 0.13%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Uline
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-27
Substance
BENZALKONIUM CHLORIDE
Active strength
1.313 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand WashBENZALKONIUM CHLORIDE 0.13%Uline9e7a97a0-f3dd-40cf-b25e-8ebb656939262026-02-17Warnings, Adverse reactionsExact identifier
ndc (package): 69790-488-08
ndc (product): 69790-488
ndc11 (package): 69790048808

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial Hand Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.313 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
9e7a97a0-f3dd-40cf-b25e-8ebb65693926Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69790-488-082022-09-26C16284748780-1e4f33bdf-a3e2-d8a0-e053-dadaa90a6e4eUline 488.003/488AD Light Moisturizing Antibacterial Hand Soap
69790-488-082022-07-29C16284748780-1e4f33bdf-a3e2-d8a0-e053-dadaa90a6e4eUline 488.003/488AD Light Moisturizing Antibacterial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69790-488-08Antibacterial Hand Wash3785 mL in 1 BOTTLE, PLASTICLIQUID378511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69790-488ANTIBACTERIAL HAND WASH (BENZALKONIUM CHLORIDE 0.13%) LIQUID [ULINE]9Current NDC, Legacy NDC, 1 package rows20240929_9e7a97a0-f3dd-40cf-b25e-8ebb65693926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN9e7a97a0-f3dd-40cf-b25e-8ebb6569392611
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD9e7a97a0-f3dd-40cf-b25e-8ebb6569392611
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY9e7a97a0-f3dd-40cf-b25e-8ebb6569392611
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY9e7a97a0-f3dd-40cf-b25e-8ebb6569392611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69790-488-08697900488083785 mL in 1 BOTTLE, PLASTIC (69790-488-08) 3785 ml2018-05-270000-00-00NoNoCurrent