FDA.reportPublic FDA data

Fresh Hands

Product NDC
77617-009
11-digit product format
776170009
Labeler code
77617
Product ID
77617-009_fe2dba8a-6bee-4124-b0b4-fedd03d011d2
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Maintex
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-16
Substance
BENZALKONIUM CHLORIDE
Active strength
13 kg/100kg
NDC exclude flag
No
Listing certified through
2026-12-31
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
Fresh Hands
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 kg/100kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e174083a-8820-4fa7-8cc2-0a2c86f27cd6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77617-009-01Fresh Hands3.80564 kg in 1 BOTTLE, PLASTICLIQUID3.805648
77617-009-02Fresh Hands1 in 1 BOXLIQUID18
77617-009-03Fresh Hands1.01 kg in 1 BOTTLE, PLASTICLIQUID1.018
77617-009-04Fresh Hands1 in 1 BOXLIQUID18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77617-009FRESH HANDS (BENZALKONIUM CHLORIDE) LIQUID [MAINTEX]7Current NDC, Legacy NDC, 4 package rows20241212_e174083a-8820-4fa7-8cc2-0a2c86f27cd6.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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77617-009-01776170009013.80564 kg in 1 BOTTLE, PLASTIC3.80564 kgHistorical
77617-009-02776170009021 BOTTLE, PLASTIC in 1 BOX (77617-009-02) / 3.80564 kg in 1 BOTTLE, PLASTIC (77617-009-01) 2018-09-170000-00-00NoNoCurrent
77617-009-03776170009031.01 kg in 1 BOTTLE, PLASTIC1.01 kgHistorical
77617-009-04776170009041 BOTTLE, PLASTIC in 1 BOX (77617-009-04) / 1.01 kg in 1 BOTTLE, PLASTIC (77617-009-03) 2018-09-17NoNoCurrent