ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES

Product NDC
78089-047
Requested package NDC
78089-047-03
11-digit product format
780890047
Labeler code
78089
Product ID
78089-047_a360479b-aadc-4020-908f-d4892c351764
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-05
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
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 packagepackage78089-04778089-047-03IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78089-047-01ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES3.67 g in 1 PACKAGECLOTH3.672
78089-047-01ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES72 in 1 PACKETCLOTH722
78089-047-02ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES4.11 g in 1 PACKAGECLOTH4.112
78089-047-02ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES72 in 1 CANISTERCLOTH722
78089-047-03ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES100 in 1 CANISTERCLOTH1002
78089-047-03ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES3.24 g in 1 PACKAGECLOTH3.242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78089-047ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [ENDEKS KIMYA SANAYI VE TICARET ANONIM SIRKETI]2Legacy NDC, 6 package rows20200922_daf28603-391c-41bd-9b34-5143aac74003.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNdaf28603-391c-41bd-9b34-5143aac740032
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDdaf28603-391c-41bd-9b34-5143aac740032
1038558benzalkonium chloride 0.13 % Topical ClothSYdaf28603-391c-41bd-9b34-5143aac740032
1038558benzalkonium chloride 0.13 % Topical SwabSYdaf28603-391c-41bd-9b34-5143aac740032
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYdaf28603-391c-41bd-9b34-5143aac740032
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYdaf28603-391c-41bd-9b34-5143aac740032
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYdaf28603-391c-41bd-9b34-5143aac740032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78089-047-0378089004703100 PACKAGE in 1 CANISTER (78089-047-03) > 3.24 g in 1 PACKAGE100 package2020-09-070000-00-00NoNoCurrent