FDA.reportPublic FDA data

Premium Hand Sanitizer Gel

Product NDC
81524-111
Requested package NDC
81524-111-01
11-digit product format
815240111
Labeler code
81524
Product ID
81524-111_d70cde43-be9d-56fb-e053-2a95a90a3c4f
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
SOOTSOAP SUPPLY CO LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-12
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage81524-11181524-111-01IInactivated by FDA2026-10-16

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
81524-111-012026-01-29C16284748780-149896155-a521-586f-e063-e6dba90add90bb144885-fad6-3699-e053-2995a90aa51d
81524-111-042026-01-29C16284748780-149896155-a521-586f-e063-e6dba90add90bb144885-fad6-3699-e053-2995a90aa51d
81524-111-072026-01-29C16284748780-149896155-a521-586f-e063-e6dba90add90bb144885-fad6-3699-e053-2995a90aa51d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81524-111-01Premium Hand Sanitizer Gel5 mL in 1 BOTTLEGEL53
81524-111-04Premium Hand Sanitizer Gel60 mL in 1 BOTTLEGEL603
81524-111-07Premium Hand Sanitizer Gel473 mL in 1 BOTTLEGEL4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81524-111PREMIUM HAND SANITIZER GEL (ALCOHOL) GEL [SOOTSOAP SUPPLY CO LTD]3Legacy NDC, 3 package rows20240127_bb144885-fad6-3699-e053-2995a90aa51d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNbb144885-fad6-3699-e053-2995a90aa51d3
581662ethanol 0.7 ML/ML Topical GelSCDbb144885-fad6-3699-e053-2995a90aa51d3
581662ethanol 70 % Topical GelSYbb144885-fad6-3699-e053-2995a90aa51d3
581662ethyl alcohol 70 % Topical GelSYbb144885-fad6-3699-e053-2995a90aa51d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81524-111-01815240111015 mL in 1 BOTTLE (81524-111-01) 5 ml2021-02-120000-00-00NoNoCurrent