Hand Sanitizer

Product NDC
63002-004
11-digit product format
630020004
Labeler code
63002
Product ID
63002-004_bfc689ba-d7f8-4c16-9a13-4bd7b859bbf5
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Advanced Hygienics LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-18
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 g/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
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b225968-aff7-4959-89e1-a8edabb4d670Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63002-004-33Hand Sanitizer9.76 mL in 1 BOTTLE, SPRAYSOLUTION9.762
63002-004-50Hand Sanitizer500 mL in 1 BOTTLESOLUTION5002
63002-004-99Hand Sanitizer50 mL in 1 BOTTLESOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63002-004HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [ADVANCED HYGIENICS LLC]2Current NDC, Legacy NDC, 3 package rows20170522_1b225968-aff7-4959-89e1-a8edabb4d670.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 SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC1b225968-aff7-4959-89e1-a8edabb4d6702017-05-22WarningsExact identifier
ndc (product): 63002-004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN1b225968-aff7-4959-89e1-a8edabb4d6702
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD1b225968-aff7-4959-89e1-a8edabb4d6702
1020365benzalkonium chloride 0.13 % Topical FoamSY1b225968-aff7-4959-89e1-a8edabb4d6702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63002-004-33630020004339.76 mL in 1 BOTTLE, SPRAY (63002-004-33) 9.76 ml2017-05-180000-00-00NoNoCurrent
63002-004-5063002000450500 mL in 1 BOTTLE (63002-004-50) 500 ml2017-05-180000-00-00NoNoCurrent
63002-004-996300200049950 mL in 1 BOTTLE (63002-004-99) 50 ml2017-05-180000-00-00NoNoCurrent