FDA.reportPublic FDA data

SEREN GUARD Sanitizing Wipes

Product NDC
79183-401
Requested package NDC
79183-401-16
11-digit product format
791830401
Labeler code
79183
Product ID
79183-401_83373936-97ff-4ecb-96ac-282a243e0c6f
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Wipes
Dosage form
PATCH
Route
TOPICAL
Labeler
Prime Pace Products LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-30
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 packagepackage79183-40179183-401-16IInactivated by FDA2026-10-15

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 · 15 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79183-401-082023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-401-162023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-401-202023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79183-401-08SEREN GUARD Sanitizing Wipes80 in 1 BOTTLE, DISPENSINGPATCH802
79183-401-08SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92
79183-401-16SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92
79183-401-16SEREN GUARD Sanitizing Wipes160 in 1 BOTTLE, DISPENSINGPATCH1602
79183-401-20SEREN GUARD Sanitizing Wipes200 in 1 BOTTLE, DISPENSINGPATCH2002
79183-401-20SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79183-401SEREN GUARD SANITIZING WIPES (SANITIZING WIPES) PATCH [PRIME PACE PRODUCTS LLC]2Legacy NDC, 6 package rows20201208_8595d28d-9870-4045-ad6b-aedefa6c93d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 % Topical ClothSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 % Topical SwabSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY8595d28d-9870-4045-ad6b-aedefa6c93d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79183-401-1679183040116160 PATCH in 1 BOTTLE, DISPENSING (79183-401-16) > 4.9 g in 1 PATCH160 patch2020-07-300000-00-00NoNoCurrent