FDA.reportPublic FDA data

AQUALABS ANTISEPTIC HAND SANITIZER

Product NDC
80953-894
Requested package NDC
80953-894-10
11-digit product format
809530894
Labeler code
80953
Product ID
80953-894_c737fae6-1b01-4506-a6a1-fe75697132c2
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Aquatonale FZC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-26
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
72 mL/100mL
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 packagepackage80953-89480953-894-10IInactivated 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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage80953-89480953-894-10IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage80953-89480953-894-10IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80953-89480953-894-10IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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
80953-894-102026-01-29C16284748780-1d6a99b39-7fdf-a426-e053-dadaa90af4c2AQUALABS ANTISEPTIC HAND SANITIZER GEL
80953-894-102022-11-16C16284748780-1d6a99b39-7fdf-a426-e053-dadaa90af4c2AQUALABS ANTISEPTIC HAND SANITIZER GEL
80953-894-102022-01-28C16284748780-1d6a99b39-7fdf-a426-e053-dadaa90af4c2AQUALABS ANTISEPTIC HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80953-894-10AQUALABS ANTISEPTIC HAND SANITIZER295.7 mL in 1 BOTTLE, PLASTICGEL295.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80953-894AQUALABS ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [AQUATONALE FZC]3Legacy NDC, 1 package rows20241212_86057011-e944-4683-aaa9-e21711be3cfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2277550ethanol 72 % Topical GelPSN86057011-e944-4683-aaa9-e21711be3cfc3
2277550ethanol 0.72 ML/ML Topical GelSCD86057011-e944-4683-aaa9-e21711be3cfc3
2277550ethanol 72 % Topical GelSY86057011-e944-4683-aaa9-e21711be3cfc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80953-894-1080953089410295.7 mL in 1 BOTTLE, PLASTIC (80953-894-10) 295.7 ml2020-11-260000-00-00NoNoCurrent