FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
74546-001
Requested package NDC
74546-001-04
11-digit product format
745460001
Labeler code
74546
Product ID
74546-001_a3418586-20e6-b759-e053-2995a90ade2e
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Board of Regents of the University of Nebraska
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage74546-00174546-001-04IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
74546-001-01d6a99b39-d5a0-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-02d6a99b39-d5a0-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-03d6a99b39-d5a0-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-04d6a99b39-d5a0-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-05d6a99b39-d5a0-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-06d6a99b39-a2a5-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-07d6a99b39-a2a5-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-08d6a99b39-a2a5-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-09d6a99b39-a2a5-a426-e053-dadaa90af4c2Hand Sanitizer
74546-001-10d6a99b39-a2a5-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74546-001-01Hand Sanitizer3785.4 mL in 1 BOTTLE, PLASTICGEL3785.41
74546-001-02Hand Sanitizer9463.3 mL in 1 BOTTLE, PLASTICGEL9463.31
74546-001-03Hand Sanitizer18927.1 mL in 1 BOTTLE, PLASTICGEL18927.11
74546-001-04Hand Sanitizer946350 mL in 1 TANKGEL9463501
74546-001-05Hand Sanitizer1211328 mL in 1 TANKGEL12113281
74546-001-06Hand Sanitizer908499 mL in 1 TANKGEL9084991
74546-001-07Hand Sanitizer435322 mL in 1 TANKGEL4353221
74546-001-08Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
74546-001-09Hand Sanitizer5000 mL in 1 BOTTLEGEL50001
74546-001-10Hand Sanitizer15142 mL in 1 BOTTLEGEL151421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74546-001HAND SANITIZER (ALCOHOL) GEL [BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA]1Legacy NDC, 5 package rows20200403_a251ff19-2aaf-ce23-e053-2a95a90a5ba2.zip
74546-001HAND SANITIZER (ALCOHOL) GEL [BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA]1Legacy NDC, 5 package rows20200415_a3418b19-08c3-5fbd-e053-2a95a90a496c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSNa251ff19-2aaf-ce23-e053-2a95a90a5ba21
1041498ethanol 80 % Topical GelPSNa3418b19-08c3-5fbd-e053-2a95a90a496c1
1041498ethanol 0.8 ML/ML Topical GelSCDa251ff19-2aaf-ce23-e053-2a95a90a5ba21
1041498ethanol 0.8 ML/ML Topical GelSCDa3418b19-08c3-5fbd-e053-2a95a90a496c1
1041498ethanol 80 % Topical GelSYa251ff19-2aaf-ce23-e053-2a95a90a5ba21
1041498ethanol 80 % Topical GelSYa3418b19-08c3-5fbd-e053-2a95a90a496c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74546-001-0474546000104946350 mL in 1 TANK (74546-001-04) 946350 ml2020-03-300000-00-00NoNoCurrent