Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer

Product NDC
90119-001
11-digit product format
901190001
Labeler code
90119
Product ID
90119-001_c2c4ca11-39c0-43e8-e053-2995a90ab4ce
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Orbizorb LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-30
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct90119-001IInactivated by FDA2026-10-05
excluded packagepackage90119-00190119-001-02IInactivated by FDA2026-10-05
excluded packagepackage90119-00190119-001-40IInactivated by FDA2026-10-05
excluded packagepackage90119-00190119-001-80IInactivated 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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage90119-001-80IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage90119-001-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage90119-001-40IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage90119-001-80IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage90119-001-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage90119-001-40IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage90119-001-80IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage90119-001-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage90119-001-40IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage90119-001-80IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage90119-001-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage90119-001-40IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage90119-001-80IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage90119-001-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage90119-001-40IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage90119-001-80IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage90119-001-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage90119-001-40IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage90119-001-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage90119-001-40UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage90119-001-80UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage90119-001-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage90119-001-40UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage90119-001-80UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage90119-001-02UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage90119-001-40UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage90119-001-80UExcluded 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
90119-001-02Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer2 in 1 PACKAGECLOTH24
90119-001-02Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer7.656 g in 1 PATCHCLOTH7.6564
90119-001-40Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer40 in 1 PACKAGECLOTH404
90119-001-40Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer7.656 g in 1 PATCHCLOTH7.6564
90119-001-80Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer612.48 g in 1 PATCHCLOTH612.484
90119-001-80Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer80 in 1 CANISTERCLOTH804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90119-001ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER (BENZALKONIUM CHLORIDE) CLOTH [ORBIZORB LLC]4Legacy NDC, 6 package rows20231027_ad67aa59-1fe5-0d75-e053-2995a90ac7e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNad67aa59-1fe5-0d75-e053-2995a90ac7e04
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDad67aa59-1fe5-0d75-e053-2995a90ac7e04
1038558benzalkonium chloride 0.13 % Topical ClothSYad67aa59-1fe5-0d75-e053-2995a90ac7e04
1038558benzalkonium chloride 0.13 % Topical SwabSYad67aa59-1fe5-0d75-e053-2995a90ac7e04
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYad67aa59-1fe5-0d75-e053-2995a90ac7e04
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYad67aa59-1fe5-0d75-e053-2995a90ac7e04
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYad67aa59-1fe5-0d75-e053-2995a90ac7e04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
90119-001-02901190001022 PATCH in 1 PACKAGE (90119-001-02) > 7.656 g in 1 PATCH2 patch2020-09-200000-00-00NoNoCurrent
90119-001-409011900014040 PATCH in 1 PACKAGE (90119-001-40) > 7.656 g in 1 PATCH40 patch2020-09-200000-00-00NoNoCurrent
90119-001-809011900018080 PATCH in 1 CANISTER (90119-001-80) > 612.48 g in 1 PATCH80 patch2020-08-300000-00-00NoNoCurrent