Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E

Product NDC
80684-007
11-digit product format
806840007
Labeler code
80684
Product ID
80684-007_08a01894-2d81-5945-e063-6394a90a6404
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-10
Substance
BENZALKONIUM CHLORIDE
Active strength
1 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
Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038856

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-007-20Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E3.5 mL in 1 PATCHCLOTH3.52
80684-007-20Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E20 in 1 BAGCLOTH202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-007THERAPLUS ANTIBACTERIAL WIPES FRESH SCENT WITH ALOE AND VITAMIN E (BENZALKONIUM CHLORIDE) CLOTH [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 2 package rows20231027_b3ece54b-6e1e-08a7-e053-2a95a90a363e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSNb3ece54b-6e1e-08a7-e053-2a95a90a363e2
1038856benzalkonium chloride 1 MG/ML Medicated PadSCDb3ece54b-6e1e-08a7-e053-2a95a90a363e2
1038856benzalkonium chloride 0.1 % Medicated WipesSYb3ece54b-6e1e-08a7-e053-2a95a90a363e2
1038856benzalkonium chloride 0.1 % Topical SwabSYb3ece54b-6e1e-08a7-e053-2a95a90a363e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80684-007-208068400072020 PATCH in 1 BAG (80684-007-20) / 3.5 mL in 1 PATCH20 patch2020-11-100000-00-00NoNoCurrent