Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E

Product NDC
80684-007
Requested package NDC
80684-007-20
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 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
1038856Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3ece54b-6e1e-08a7-e053-2a95a90a363eAvailable on FDA.report

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

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
Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin EBENZALKONIUM CHLORIDEFourstar Group USA, Inc.b3ece54b-6e1e-08a7-e053-2a95a90a363e2023-10-26WarningsExact identifier
ndc (package): 80684-007-20
ndc (product): 80684-007
ndc11 (package): 80684000720

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