FDA.reportPublic FDA data

HAND SANITIZER

Product NDC
80581-087
11-digit product format
805810087
Labeler code
80581
Product ID
80581-087_95aaf4a7-c13a-4ebe-8006-7bc0e0a7a66b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
QuadSil Inc
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-21
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80581-087IInactivated by FDA2026-10-15
excluded packagepackage80581-08780581-087-01IInactivated 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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage80581-087-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage80581-087-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage80581-087-011332a3947898…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
80581-087-012024-05-31C16284748780-11030e365-5b47-111a-e063-dadaa90a10e2HAND SANITIZER
80581-087-012024-01-30C16284748780-11030e365-5b47-111a-e063-dadaa90a10e2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80581-087-01HAND SANITIZER30 mL in 1 BOTTLEGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80581-087HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [QUADSIL INC]4Legacy NDC, 1 package rows20240601_5bb703cd-ff43-4605-a72d-2c78305105d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN5bb703cd-ff43-4605-a72d-2c78305105d94
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD5bb703cd-ff43-4605-a72d-2c78305105d94
1049228benzalkonium chloride 0.1 % Topical GelSY5bb703cd-ff43-4605-a72d-2c78305105d94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80581-087-018058100870130 mL in 1 BOTTLE (80581-087-01) 30 ml2020-09-210000-00-00NoNoCurrent