FDA.reportPublic FDA data

DISINFECTING WIPES

Product NDC
75328-301
Requested package NDC
75328-301-06
11-digit product format
753280301
Labeler code
75328
Product ID
75328-301_aae0ce1d-c864-58ab-e053-2995a90a865c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride,DiDecyl dimethyl ammonium chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
DIDECYLDIMONIUM CHLORIDE; BENZALKONIUM CHLORIDE
Active strength
0 1/1001; 1/1001
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 packagepackage75328-30175328-301-06IInactivated 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#

NDC, Related label table
NDCRelated label
75328-301-01DISINFECTING WIPES
75328-301-02DISINFECTING WIPES
75328-301-03DISINFECTING WIPES
75328-301-04DISINFECTING WIPES
75328-301-05DISINFECTING WIPES
75328-301-06DISINFECTING WIPES
75328-301-07DISINFECTING WIPES
75328-301-08DISINFECTING WIPES
75328-301-09DISINFECTING WIPES
75328-301-10DISINFECTING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75328-301-01DISINFECTING WIPES1 in 1 BAGCLOTH11
75328-301-02DISINFECTING WIPES10 in 1 BAGCLOTH101
75328-301-03DISINFECTING WIPES20 in 1 BAGCLOTH201
75328-301-04DISINFECTING WIPES30 in 1 BAGCLOTH301
75328-301-05DISINFECTING WIPES50 in 1 BAGCLOTH501
75328-301-06DISINFECTING WIPES75 in 1 BAGCLOTH751
75328-301-07DISINFECTING WIPES80 in 1 BAGCLOTH801
75328-301-08DISINFECTING WIPES100 in 1 BAGCLOTH1001
75328-301-09DISINFECTING WIPES120 in 1 BAGCLOTH1201
75328-301-10DISINFECTING WIPES160 in 1 BAGCLOTH1601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75328-301DISINFECTING WIPES (BENZALKONIUM CHLORIDE,DIDECYL DIMETHYL AMMONIUM CHLORIDE) CLOTH [CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.]1Legacy NDC, 10 package rows20200721_aae0c17f-985e-a9bc-e053-2995a90a9bb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75328-301-067532803010675 CLOTH in 1 BAG (75328-301-06) 75 cloth2020-03-300000-00-00NoNoCurrent