FDA.reportPublic FDA data

SaniHands

Product NDC
80497-001
11-digit product format
804970001
Labeler code
80497
Product ID
80497-001_73160761-1b93-4c3c-af69-d5887fc1fdf2
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Dynasty Chemical Corp.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80497-001IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-01IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-02IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-03IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-04IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-05IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-91IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-92IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-93IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-94IInactivated by FDA2026-10-05
excluded packagepackage80497-00180497-001-95IInactivated 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 4 · 198 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 packagepackage80497-001-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80497-001-91d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80497-001-91f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80497-001-912ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80497-001-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-95cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-94cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage80497-001-91cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80497-001-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80497-001-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80497-001-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage80497-001-01cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80497-001-01SaniHands GEL HAND SANITIZER
80497-001-02SaniHands GEL HAND SANITIZER
80497-001-03SaniHands GEL HAND SANITIZER
80497-001-04SaniHands GEL HAND SANITIZER
80497-001-05SaniHands GEL HAND SANITIZER
80497-001-91SaniHands GEL HAND SANITIZER
80497-001-92SaniHands GEL HAND SANITIZER
80497-001-93SaniHands GEL HAND SANITIZER
80497-001-94SaniHands GEL HAND SANITIZER
80497-001-95SaniHands GEL HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80497-001-01SaniHandsGel Hand Sanitizer3790 mL in 1 BOTTLE, PLASTICGEL37901
80497-001-02SaniHandsGel Hand Sanitizer950 mL in 1 BOTTLE, PLASTICGEL9501
80497-001-03SaniHandsGel Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731
80497-001-04SaniHandsGel Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
80497-001-05SaniHandsGel Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
80497-001-91SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-92SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-93SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-94SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-95SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80497-001SANIHANDS GEL HAND SANITIZER (ETHYL ALCOHOL) GEL [DYNASTY CHEMICAL CORP.]1Legacy NDC, 10 package rows20201126_b9cce04b-a875-416c-9c9e-0ebfa9d9d018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSNb9cce04b-a875-416c-9c9e-0ebfa9d9d0181
902574ethanol 0.65 ML/ML Topical GelSCDb9cce04b-a875-416c-9c9e-0ebfa9d9d0181
902574ethyl alcohol 65 % Topical GelSYb9cce04b-a875-416c-9c9e-0ebfa9d9d0181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80497-001-01804970001013790 mL in 1 BOTTLE, PLASTIC (80497-001-01) 3790 ml2020-09-010000-00-00NoNoCurrent
80497-001-0280497000102950 mL in 1 BOTTLE, PLASTIC (80497-001-02) 950 ml2020-09-010000-00-00NoNoCurrent
80497-001-0380497000103473 mL in 1 BOTTLE, PLASTIC (80497-001-03) 473 ml2020-09-010000-00-00NoNoCurrent
80497-001-0480497000104236 mL in 1 BOTTLE, PLASTIC (80497-001-04) 236 ml2020-09-010000-00-00NoNoCurrent
80497-001-0580497000105118 mL in 1 BOTTLE, PLASTIC (80497-001-05) 118 ml2020-09-010000-00-00NoNoCurrent
80497-001-91804970001911 BOTTLE, PLASTIC in 1 CASE (80497-001-91) > 3790 mL in 1 BOTTLE, PLASTIC (80497-001-01) 2020-09-010000-00-00NoNoCurrent
80497-001-92804970001921 BOTTLE, PLASTIC in 1 CASE (80497-001-92) > 950 mL in 1 BOTTLE, PLASTIC (80497-001-02) 2020-09-010000-00-00NoNoCurrent
80497-001-93804970001931 BOTTLE, PLASTIC in 1 CASE (80497-001-93) > 473 mL in 1 BOTTLE, PLASTIC (80497-001-03) 2020-09-010000-00-00NoNoCurrent
80497-001-94804970001941 BOTTLE, PLASTIC in 1 CASE (80497-001-94) > 236 mL in 1 BOTTLE, PLASTIC (80497-001-04) 2020-09-010000-00-00NoNoCurrent
80497-001-95804970001951 BOTTLE, PLASTIC in 1 CASE (80497-001-95) > 118 mL in 1 BOTTLE, PLASTIC (80497-001-05) 2020-09-010000-00-00NoNoCurrent