Byotrol Hand Sanitizer

Product NDC
63002-002
11-digit product format
630020002
Labeler code
63002
Product ID
63002-002_ef6a1c09-8491-4a08-bedc-a67ce00d9e23
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Advanced Hygienics LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-05-02
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
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
09edbc17-c443-4b0d-9c28-c4b8233c4d1aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63002-002-12Byotrol Hand Sanitizer1250 mL in 1 BOTTLELIQUID12506
63002-002-50Byotrol Hand Sanitizer500 mL in 1 BOTTLELIQUID5006
63002-002-75Byotrol Hand Sanitizer9463 mL in 1 BOTTLELIQUID94636
63002-002-99Byotrol Hand Sanitizer50 mL in 1 BOTTLELIQUID506

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7BYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
C12-15 PARETH-7INACTIVE INGREDIENT3XY03A79QHBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
CAPRYLYL GLUCOSIDEINACTIVE INGREDIENTV109WUT6RLBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
DIHYDROXYETHYL COCAMINE OXIDEINACTIVE INGREDIENT8AR51R3BL5BYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
GLYCERETH-17 COCOATEINACTIVE INGREDIENT3057VPT0KCBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
LAURTRIMONIUM CHLORIDEINACTIVE INGREDIENTA81MSI0FICBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
POLIHEXANIDEINACTIVE INGREDIENT322U039GMFBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RBYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCE HYGIENICS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63002-002BYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCED HYGIENICS LLC]6Current NDC, Legacy NDC, 4 package rows20171214_09edbc17-c443-4b0d-9c28-c4b8233c4d1a.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
Byotrol Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC09edbc17-c443-4b0d-9c28-c4b8233c4d1a2017-12-14WarningsExact identifier
ndc (product): 63002-002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN09edbc17-c443-4b0d-9c28-c4b8233c4d1a6
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD09edbc17-c443-4b0d-9c28-c4b8233c4d1a6
1020365benzalkonium chloride 0.13 % Topical FoamSY09edbc17-c443-4b0d-9c28-c4b8233c4d1a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63002-002-12630020002121250 mL in 1 BOTTLE (63002-002-12) 1250 ml2014-06-250000-00-00NoNoCurrent
63002-002-5063002000250500 mL in 1 BOTTLE (63002-002-50) 500 ml2014-06-250000-00-00NoNoCurrent
63002-002-75630020002759463 mL in 1 BOTTLE (63002-002-75) 9463 ml2015-04-010000-00-00NoNoCurrent
63002-002-996300200029950 mL in 1 BOTTLE (63002-002-99) 50 ml2014-05-020000-00-00NoNoCurrent