FDA.reportPublic FDA data

Wet Ones Antibacterial Hand Wipes Tropical Splash

Product NDC
63354-989
Requested package NDC
63354-989-24
11-digit product format
633540989
Labeler code
63354
Product ID
63354-989_d579f41e-bf00-240b-e053-2995a90a8ef8
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SWAB
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-09-26
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 1/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63354-98963354-989-24DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63354-989-152025-03-279351b508-9828-8d02-e053-2a95a90a3770
63354-989-242025-03-279351b508-9828-8d02-e053-2a95a90a3770
63354-989-402025-03-279351b508-9828-8d02-e053-2a95a90a3770
63354-989-152025-01-309351b508-9828-8d02-e053-2a95a90a3770
63354-989-242025-01-309351b508-9828-8d02-e053-2a95a90a3770
63354-989-402025-01-309351b508-9828-8d02-e053-2a95a90a3770

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-989-246335409892424 SWAB in 1 PACKET (63354-989-24) 24 swab2019-09-260000-00-00NoNoCurrent