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 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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6130f88-a274-4068-9d8e-5f898b3b074fAvailable on FDA.report

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

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
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corpf6130f88-a274-4068-9d8e-5f898b3b074f2025-12-31WarningsExact identifier
ndc (product): 78691-022

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 patch2023-08-07NoNoCurrent