ANTI-BACTERIAL WET WIPES

Product NDC
78028-004
Requested package NDC
78028-004-08
11-digit product format
780280004
Labeler code
78028
Product ID
78028-004_d5983e19-5987-2a64-e053-2a95a90a4333
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Dalian Daxin Nonwoven Technology Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-20
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78028-00478028-004-08DDiscontinued by firm2026-10-05
excluded packagepackage78028-00478028-004-08IInactivated 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 · 27 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…
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78028-004-01ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-01ANTI-BACTERIAL WET WIPES50 in 1 PAILCLOTH503
78028-004-02ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-02ANTI-BACTERIAL WET WIPES70 in 1 PAILCLOTH703
78028-004-03ANTI-BACTERIAL WET WIPES80 in 1 PAILCLOTH803
78028-004-03ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-04ANTI-BACTERIAL WET WIPES100 in 1 PAILCLOTH1003
78028-004-04ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-05ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-05ANTI-BACTERIAL WET WIPES30 in 1 BAGCLOTH303
78028-004-06ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-06ANTI-BACTERIAL WET WIPES40 in 1 BAGCLOTH403
78028-004-07ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-07ANTI-BACTERIAL WET WIPES50 in 1 BAGCLOTH503
78028-004-08ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-08ANTI-BACTERIAL WET WIPES60 in 1 BAGCLOTH603
78028-004-09ANTI-BACTERIAL WET WIPES80 in 1 BAGCLOTH803
78028-004-09ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-10ANTI-BACTERIAL WET WIPES150 in 1 PAILCLOTH1503
78028-004-10ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78028-004ANTI-BACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [DALIAN DAXIN NONWOVEN TECHNOLOGY CO., LTD.]3Legacy NDC, 20 package rows20220115_ab2def5c-5033-902a-e053-2a95a90af986.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNab2def5c-5033-902a-e053-2a95a90af9863
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDab2def5c-5033-902a-e053-2a95a90af9863
1038558benzalkonium chloride 0.13 % Topical ClothSYab2def5c-5033-902a-e053-2a95a90af9863
1038558benzalkonium chloride 0.13 % Topical SwabSYab2def5c-5033-902a-e053-2a95a90af9863
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYab2def5c-5033-902a-e053-2a95a90af9863
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYab2def5c-5033-902a-e053-2a95a90af9863
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYab2def5c-5033-902a-e053-2a95a90af9863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78028-004-087802800040860 NOT APPLICABLE in 1 BAG (78028-004-08) > 6.5 g in 1 NOT APPLICABLE60 not applicable2020-07-200000-00-00NoNoCurrent