Omnicide Antimicrobial

Product NDC
69085-466
Requested package NDC
69085-466-05
11-digit product format
690850466
Labeler code
69085
Product ID
69085-466_ec1fd4c9-3184-521c-e053-2995a90a9b37
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
SteriWeb Medical, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-05-07
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69085-46669085-466-05IInactivated 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 · 9 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 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
69085-466-02Omnicide Antimicrobial45 g in 1 TUBEGEL4510
69085-466-05Omnicide Antimicrobial30 g in 1 TUBEGEL307

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69085-466OMNICIDE ANTIMICROBIAL (BENZALKONIUM CHLORIDE) GEL [STERIWEB MEDICAL, LLC]10Legacy NDC, 1 package rows20230926_20b6fc0a-317b-4b94-b598-c53ebea114fe.zip
69085-466OMNICIDE ANTIMICROBIAL (BENZALKONIUM CHLORIDE) GEL [STERIWEB MEDICAL, LLC]7Legacy NDC, 1 package rows20230927_fd16f21f-c152-4811-b57e-7c0c96b4aadb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN20b6fc0a-317b-4b94-b598-c53ebea114fe10
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD20b6fc0a-317b-4b94-b598-c53ebea114fe10
1098199benzalkonium chloride 0.13 % Topical GelSY20b6fc0a-317b-4b94-b598-c53ebea114fe10
1098199benzalkonium chloride 0.13 % Topical GelPSNfd16f21f-c152-4811-b57e-7c0c96b4aadb7
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCDfd16f21f-c152-4811-b57e-7c0c96b4aadb7
1098199benzalkonium chloride 0.13 % Topical GelSYfd16f21f-c152-4811-b57e-7c0c96b4aadb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69085-466-056908504660530 g in 1 TUBE (69085-466-05) 30 g2016-05-070000-00-00NoNoCurrent