FDA.reportPublic FDA data

Premium Protection Antibacterial Hand

Product NDC
77617-002
11-digit product format
776170002
Labeler code
77617
Product ID
77617-002_b5076cff-1836-4873-b552-ec38eea80c45
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Maintex
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-15
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
Premium Protection Antibacterial Hand
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
53bd6860-dde3-4525-ba1b-50f69be09abcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77617-002-01Premium Protection Antibacterial Hand3.80564 kg in 1 BOTTLE, PLASTICLIQUID3.805648
77617-002-02Premium Protection Antibacterial Hand4 in 1 BOXLIQUID48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77617-002PREMIUM PROTECTION ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [MAINTEX]7Current NDC, Legacy NDC, 2 package rows20241215_53bd6860-dde3-4525-ba1b-50f69be09abc.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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Street Antibacterial Liquid HandBENZALKONIUM CHLORIDEAmerifoods Trading Companye9d5fefa-970b-42ba-8139-18e5644153442025-11-06WarningsExact identifier
application number: M
CetirzaCETIRIZINE HCLHART Health44b22f6f-5731-4dfe-af33-4e4e54fc3af52025-10-06WarningsExact identifier
application number: M
Dolce and Gabbana Blueberry Nutri Tint SPF 20 6W LightZINC OXIDEDolce & Gabbana Beauty S.R.Ld2930d0e-c622-4843-87f2-fa1a92837ff22025-09-05WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed959815e5-a73b-4905-9d7d-904b334983862025-08-15WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthc1903b9f-390a-4756-800c-fd93be4182e32025-08-13Warnings, Adverse reactionsExact identifier
application number: M
THERASTATCHERRY COUGH DROPSHART Health96bae19a-3337-4199-9b8c-cdf9b368178b2025-08-04WarningsExact identifier
application number: M
Docu LiquidDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.f4ed0721-3be9-4108-a6c9-dbbe115249e92025-07-31WarningsExact identifier
application number: M
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.ac6a47e7-972f-4b82-96da-89926d345e9f2025-07-31WarningsExact identifier
application number: M
SENNASENNAATLANTIC BIOLOGICALS CORP.8b7cc0d5-029b-43f7-a050-8771e7db45512025-07-31WarningsExact identifier
application number: M
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGATLANTIC BIOLOGICALS CORP.4c02fcec-6bb7-4497-96c5-0d809209dd172025-06-27WarningsExact identifier
application number: M
Orythia Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d658d495-dd2c-40b7-9446-6f10040ed55e2025-06-27WarningsExact identifier
application number: M
Bonica EaseX Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.34f1196a-fda1-4bef-be71-e5a09ee97bc12025-06-27WarningsExact identifier
application number: M
Regular Strength Enteric coated aspirinASPIRINATLANTIC BIOLOGICALS CORP.e1c8d0ed-da1d-4b1a-9a85-7b8532775f872025-06-24WarningsExact identifier
application number: M
Aspirin Low Dose Chewable OrangeASPIRINATLANTIC BIOLOGICALS CORP.a0d8ee59-1ce0-4ddd-a90c-54adb512540c2025-06-24WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Healthf50af223-ba83-458a-a557-1ba5dc221a9c2025-06-10WarningsExact identifier
application number: M
Pharbetol Regular strengthACETAMINOPHENATLANTIC BIOLOGICALS CORP.05a91d24-b498-4ba2-a275-68b871cf62d22025-06-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
application number: M
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
application number: M
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEATLANTIC BIOLOGICALS CORP.5c02d0ba-91e4-4bd2-ac66-6905323653b22025-05-12WarningsExact identifier
application number: M
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINATLANTIC BIOLOGICALS CORP.8f496c61-41a6-41ba-80f5-7a5309c4d18b2025-05-12WarningsExact identifier
application number: M

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77617-002-01776170002013.80564 kg in 1 BOTTLE, PLASTIC3.80564 kgHistorical
77617-002-02776170002024 BOTTLE, PLASTIC in 1 BOX (77617-002-02) / 3.80564 kg in 1 BOTTLE, PLASTIC (77617-002-01) 2018-04-150000-00-00NoNoCurrent