Hand Sanitzer

Product NDC
80511-001
11-digit product format
805110001
Labeler code
80511
Product ID
80511-001_b8b965a7-d88a-c03b-e053-2995a90aa128
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Luxe Decor Sales Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-04
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
740 mL/1000mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80511-001IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-01IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-02IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-03IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-04IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-05IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-06IInactivated by FDA2026-10-05
excluded packagepackage80511-00180511-001-07IInactivated 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 3 · 128 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80511-001-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80511-001-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80511-001-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80511-001-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80511-001-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80511-001-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage80511-001-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage80511-001-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage80511-001-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage80511-001-02ed331223b511…672a5bd82f5f…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80511-001-01Hand Sanitzer50 mL in 1 BOTTLEGEL502
80511-001-02Hand Sanitzer50 mL in 1 BOTTLEGEL502
80511-001-03Hand Sanitzer80 mL in 1 BOTTLEGEL802
80511-001-04Hand Sanitzer236 mL in 1 BOTTLEGEL2362
80511-001-05Hand Sanitzer500 mL in 1 BOTTLEGEL5002
80511-001-06Hand Sanitzer1000 mL in 1 BOTTLEGEL10002
80511-001-07Hand Sanitzer3780 mL in 1 BOTTLEGEL37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80511-001HAND SANITZER (ETHYL ALCOHOL) GEL [LUXE DECOR SALES LTD]2Legacy NDC, 7 package rows20210113_ae7f2bac-bf1e-cf54-e053-2a95a90a7396.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287762ethanol 74 % Topical GelPSNae7f2bac-bf1e-cf54-e053-2a95a90a73962
2287762ethanol 0.74 ML/ML Topical GelSCDae7f2bac-bf1e-cf54-e053-2a95a90a73962
2287762ethanol 74 % Topical GelSYae7f2bac-bf1e-cf54-e053-2a95a90a73962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80511-001-018051100010150 mL in 1 BOTTLE (80511-001-01) 50 ml2020-09-040000-00-00NoNoCurrent
80511-001-028051100010250 mL in 1 BOTTLE (80511-001-02) 50 ml2020-09-040000-00-00YesNoCurrent
80511-001-038051100010380 mL in 1 BOTTLE (80511-001-03) 80 ml2020-09-040000-00-00NoNoCurrent
80511-001-0480511000104236 mL in 1 BOTTLE (80511-001-04) 236 ml2020-09-040000-00-00NoNoCurrent
80511-001-0580511000105500 mL in 1 BOTTLE (80511-001-05) 500 ml2020-09-040000-00-00NoNoCurrent
80511-001-06805110001061000 mL in 1 BOTTLE (80511-001-06) 1000 ml2020-09-040000-00-00NoNoCurrent
80511-001-07805110001073780 mL in 1 BOTTLE (80511-001-07) 3780 ml2020-09-040000-00-00NoNoCurrent