FDA.reportPublic FDA data

antiseptic wipes

Product NDC
77412-012
Requested package NDC
77412-012-02
11-digit product format
774120012
Labeler code
77412
Product ID
77412-012_ba920d24-cd15-52be-e053-2995a90a38cc
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 1/1001
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage77412-01277412-012-02IInactivated 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 · 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
77412-012-012023-01-30C16284748780-1f386c649-d5dc-0266-e053-dadaa90a7c1asanitizing antiseptic wipes
77412-012-022023-01-30C16284748780-1f386c649-d5dc-0266-e053-dadaa90a7c1asanitizing antiseptic wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77412-012-01antiseptic wipes100 in 1 PACKAGECLOTH1002
77412-012-02antiseptic wipes10 in 1 PACKAGECLOTH102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77412-012ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) CLOTH [SHANDONG LIAOCHENG CHAOYUE DAILY NECESSITIES CO., LTD.]2Legacy NDC, 2 package rows20210206_aff86385-948d-7067-e053-2995a90a298a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNaff86385-948d-7067-e053-2995a90a298a2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDaff86385-948d-7067-e053-2995a90a298a2
1038558benzalkonium chloride 0.13 % Topical ClothSYaff86385-948d-7067-e053-2995a90a298a2
1038558benzalkonium chloride 0.13 % Topical SwabSYaff86385-948d-7067-e053-2995a90a298a2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYaff86385-948d-7067-e053-2995a90a298a2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYaff86385-948d-7067-e053-2995a90a298a2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYaff86385-948d-7067-e053-2995a90a298a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77412-012-027741200120210 CLOTH in 1 PACKAGE (77412-012-02) 10 cloth2020-03-300000-00-00NoNoCurrent