FDA.reportPublic FDA data

75 Alcohol Antiseptic Wipes

Product NDC
78405-001
Requested package NDC
78405-001-60
11-digit product format
784050001
Labeler code
78405
Product ID
78405-001_a76e69d3-e5e3-2047-e053-2995a90ad942
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
WATERMARK LIMITED
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78405-00178405-001-60IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78405-001-6075 Alcohol Antiseptic Wipes3 mL in 1 PATCHCLOTH32
78405-001-6075 Alcohol Antiseptic Wipes60 in 1 BAGCLOTH602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78405-00175 ALCOHOL ANTISEPTIC WIPES (ALCOHOL) CLOTH [WATERMARK LIMITED]2Legacy NDC, 2 package rows20231214_a76e3cf3-a67e-1720-e053-2995a90a8a41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSNa76e3cf3-a67e-1720-e053-2995a90a8a412
1307051ethanol 0.75 ML/ML Medicated PadSCDa76e3cf3-a67e-1720-e053-2995a90a8a412
1307051ethanol 75 % Hand Sanitizer WipesSYa76e3cf3-a67e-1720-e053-2995a90a8a412
1307051ethyl alcohol 75 % Topical ClothSYa76e3cf3-a67e-1720-e053-2995a90a8a412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78405-001-607840500016060 PATCH in 1 BAG (78405-001-60) > 3 mL in 1 PATCH60 patch2020-05-010000-00-00NoNoCurrent