FDA.reportPublic FDA data

AerisGuard Actisan Hand Sanitizer

Product NDC
81124-001
Requested package NDC
81124-001-09
11-digit product format
811240001
Labeler code
81124
Product ID
81124-001_efa6a572-8a60-aa1e-e053-2a95a90a5b8e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Aeris Environmental LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-24
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/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 packagepackage81124-00181124-001-09IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
81124-001-01b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-02b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-03b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-04b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-05b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-06b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-07b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-08b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-09b4e1760a-fbfd-6943-e053-2a95a90ac952
81124-001-10b4e1760a-fbfd-6943-e053-2a95a90ac952

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81124-001-01AerisGuard Actisan Hand Sanitizer60 mL in 1 BOTTLESOLUTION603
81124-001-02AerisGuard Actisan Hand Sanitizer103.5 mL in 1 BOTTLESOLUTION103.53
81124-001-03AerisGuard Actisan Hand Sanitizer118 mL in 1 BOTTLESOLUTION1183
81124-001-04AerisGuard Actisan Hand Sanitizer236 mL in 1 BOTTLESOLUTION2363
81124-001-05AerisGuard Actisan Hand Sanitizer473 mL in 1 BOTTLESOLUTION4733
81124-001-06AerisGuard Actisan Hand Sanitizer946 mL in 1 BOTTLESOLUTION9463
81124-001-07AerisGuard Actisan Hand Sanitizer3800 mL in 1 PAILSOLUTION38003
81124-001-08AerisGuard Actisan Hand Sanitizer19000 mL in 1 PAILSOLUTION190003
81124-001-09AerisGuard Actisan Hand Sanitizer209000 mL in 1 DRUMSOLUTION2090003
81124-001-10AerisGuard Actisan Hand Sanitizer1045000 mL in 1 TANKSOLUTION10450003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81124-001AERISGUARD ACTISAN HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [AERIS ENVIRONMENTAL LLC]3Legacy NDC, 10 package rows20221213_b4e1760a-fbfd-6943-e053-2a95a90ac952.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNb4e1760a-fbfd-6943-e053-2a95a90ac9523
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDb4e1760a-fbfd-6943-e053-2a95a90ac9523
1049254benzalkonium chloride 0.13 % Topical SolutionSYb4e1760a-fbfd-6943-e053-2a95a90ac9523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81124-001-0981124000109209000 mL in 1 DRUM (81124-001-09) 209000 ml2020-11-240000-00-00NoNoCurrent