FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
80751-400
Requested package NDC
80751-400-02
11-digit product format
807510400
Labeler code
80751
Product ID
80751-400_d4f59a16-666e-3108-e053-2995a90afb4c
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
SPRAY
Route
TOPICAL
Labeler
Aromas Para El Alma S.A.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-01-06
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
60 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 packagepackage80751-40080751-400-02IInactivated 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80751-400-022024-01-30C16284748780-11030e365-498e-111a-e063-dadaa90a10e2Spray Hand Sanitizer - 60 ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80751-400-02Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80751-400HAND SANITIZER SPRAY [AROMAS PARA EL ALMA S.A.]1Legacy NDC, 1 package rows20220108_d4f60223-bd8d-35de-e053-2a95a90a76d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367692ethanol 60 % Topical SprayPSNd4f60223-bd8d-35de-e053-2a95a90a76d71
1367692ethanol 0.6 ML/ML Topical SpraySCDd4f60223-bd8d-35de-e053-2a95a90a76d71
1367692ethanol 60 % Topical SpraySYd4f60223-bd8d-35de-e053-2a95a90a76d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80751-400-028075104000260 mL in 1 BOTTLE, SPRAY (80751-400-02) 60 ml2022-01-060000-00-00NoNoCurrent