FDA.reportPublic FDA data

Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent

Product NDC
78691-022
11-digit product format
786910022
Labeler code
78691
Product ID
78691-022_4744f262-3096-7b8b-e063-6394a90a214b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Quest USA Corp
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
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
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-022-00Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent40 in 1 POUCHLIQUID404
78691-022-00Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent3.9 mL in 1 PATCHLIQUID3.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-022BIOPURE ANTI-BACTERIAL HAND WIPES FRESH MORNING BREEZE SCENT (BENZALKONIUM CHLORIDE) LIQUID [QUEST USA CORP]3Current NDC, 2 package rows20241216_f6130f88-a274-4068-9d8e-5f898b3b074f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNf6130f88-a274-4068-9d8e-5f898b3b074f4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDf6130f88-a274-4068-9d8e-5f898b3b074f4
1038558benzalkonium chloride 0.13 % Topical ClothSYf6130f88-a274-4068-9d8e-5f898b3b074f4
1038558benzalkonium chloride 0.13 % Topical SwabSYf6130f88-a274-4068-9d8e-5f898b3b074f4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYf6130f88-a274-4068-9d8e-5f898b3b074f4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYf6130f88-a274-4068-9d8e-5f898b3b074f4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYf6130f88-a274-4068-9d8e-5f898b3b074f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-022-007869100220040 PATCH in 1 POUCH (78691-022-00) / 3.9 mL in 1 PATCH40 patch2023-08-07NoNoHistorical