FDA.reportPublic FDA data

Wipe Those Hands

Product NDC
78091-251
Requested package NDC
78091-251-04
11-digit product format
780910251
Labeler code
78091
Product ID
78091-251_408dfb29-a51b-70c7-e063-6294a90a949e
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Mighty Good Solutions, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-15
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
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
Wipe Those Hands
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
45b217ee-1524-4508-a18f-7db6a30d5169Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78091-251-02Wipe Those Hands20 in 1 POUCHCLOTH206
78091-251-02Wipe Those Hands4.05 mL in 1 APPLICATORCLOTH4.056
78091-251-03Wipe Those Hands42 in 1 POUCHCLOTH426
78091-251-03Wipe Those Hands4.05 mL in 1 APPLICATORCLOTH4.056
78091-251-04Wipe Those Hands1 in 1 PACKETCLOTH16
78091-251-04Wipe Those Hands10 in 1 POUCHCLOTH106
78091-251-05Wipe Those Hands30 in 1 POUCHCLOTH306
78091-251-05Wipe Those Hands1 in 1 PACKETCLOTH16
78091-251-06Wipe Those Hands40 in 1 POUCHCLOTH406
78091-251-06Wipe Those Hands4.05 mL in 1 PACKETCLOTH4.056

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78091-251WIPE THOSE HANDS (BENZALKONIUM CHLORIDE) CLOTH [MIGHTY GOOD SOLUTIONS, LLC]3Current NDC, 10 package rows20250502_45b217ee-1524-4508-a18f-7db6a30d5169.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
Wipe Those HandsBENZALKONIUM CHLORIDEMighty Good Solutions, LLC45b217ee-1524-4508-a18f-7db6a30d51692025-10-07WarningsExact identifier
ndc (package): 78091-251-04
ndc (product): 78091-251
ndc11 (package): 78091025104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 % Topical ClothSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 % Topical SwabSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY45b217ee-1524-4508-a18f-7db6a30d51696
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY45b217ee-1524-4508-a18f-7db6a30d51696

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78091-251-047809102510410 PACKET in 1 POUCH (78091-251-04) / 1 APPLICATOR in 1 PACKET / 4.05 mL in 1 APPLICATOR10 packet2023-07-15NoNoCurrent