FDA.reportPublic FDA data

Hand Wash

Product NDC
83986-460
Requested package NDC
83986-460-04
11-digit product format
839860460
Labeler code
83986
Product ID
83986-460_4cc44476-9723-2d86-e063-6394a90a7905
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
UpLift Brands, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-05
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
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
Hand Wash
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
dd992633-05fd-4544-8abe-e161828a99adAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83986-460-04Hand Wash750 mL in 1 BOTTLE, PLASTICSOAP7504
83986-460-08Hand Wash3780 mL in 1 BOTTLE, PLASTICSOAP37804
83986-460-44Hand Wash532 mL in 1 BOTTLE, PLASTICSOAP5324
83986-460-45Hand Wash1150 mL in 1 BOTTLE, PLASTICSOAP11504
83986-460-96Hand Wash221 mL in 1 BOTTLE, PLASTICSOAP2214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83986-460HAND WASH (BENZALKONIUM CHLORIDE) SOAP [UPLIFT BRANDS, LLC]3Current NDC, 5 package rows20250507_dd992633-05fd-4544-8abe-e161828a99ad.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
Hand WashBENZALKONIUM CHLORIDEUpLift Brands, LLCdd992633-05fd-4544-8abe-e161828a99ad2026-03-11Warnings, Adverse reactionsExact identifier
ndc (package): 83986-460-04
ndc (product): 83986-460
ndc11 (package): 83986046004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNdd992633-05fd-4544-8abe-e161828a99ad4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDdd992633-05fd-4544-8abe-e161828a99ad4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYdd992633-05fd-4544-8abe-e161828a99ad4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYdd992633-05fd-4544-8abe-e161828a99ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83986-460-0483986046004750 mL in 1 BOTTLE, PLASTIC (83986-460-04) 750 ml2024-02-05NoNoCurrent