FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
64596-388
11-digit product format
645960388
Labeler code
64596
Product ID
64596-388_aee5b2f4-9b44-8ac7-e053-2a95a90a9ba0
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Gilchrist & Soames
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
67 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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64596-388IInactivated by FDA2026-10-05
excluded productproduct64596-388IInactivated by FDA2026-10-05
excluded productproduct64596-388IInactivated by FDA2026-10-05
excluded productproduct64596-388IInactivated by FDA2026-10-05
excluded productproduct64596-388IInactivated by FDA2026-10-05
excluded packagepackage64596-38864596-388-08IInactivated by FDA2026-10-05
excluded packagepackage64596-38864596-388-12IInactivated by FDA2026-10-05
excluded packagepackage64596-38864596-388-16IInactivated by FDA2026-10-05
excluded packagepackage64596-38864596-388-30IInactivated by FDA2026-10-05
excluded packagepackage64596-38864596-388-88IInactivated 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 · 150 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64596-388-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64596-388-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64596-388-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64596-388-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64596-388-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64596-388-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64596-388-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64596-388-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64596-388-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64596-388-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64596-388-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64596-388-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64596-388-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64596-388-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64596-388-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64596-388-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64596-388-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64596-388-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64596-388-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64596-388-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64596-388-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64596-388-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64596-388-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64596-388-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64596-388-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64596-388-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64596-388-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64596-388-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64596-388-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64596-388-30cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
64596-388-080191ceaa-6a9f-198a-e063-dbdaa90aec3eG&S Instant Hand Sanitizer 0.8oz 24mL
64596-388-120191ceaa-64e4-198a-e063-dbdaa90aec3eG&S Instant Hand Sanitizer 1.25oz 37mL
64596-388-160191ceaa-67c8-198a-e063-dbdaa90aec3eG&S Instant Hand Sanitizer 16oz 473mL
64596-388-300191ceaa-651c-198a-e063-dbdaa90aec3eG&S Instant Hand Sanitizer 30oz 887mL
64596-388-880191ceaa-62e3-198a-e063-dbdaa90aec3eG&S Instant Hand Sanitizer 1 gallon 3780 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64596-388-08Hand Sanitizer24 mL in 1 BOTTLE, PLASTICSOLUTION241
64596-388-12Hand Sanitizer37 mL in 1 BOTTLE, PLASTICSOLUTION371
64596-388-16Hand Sanitizer473 mL in 1 BOTTLE, PLASTICSOLUTION4731
64596-388-30Hand Sanitizer887 mL in 1 BOTTLE, PLASTICSOLUTION8871
64596-388-88Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICSOLUTION37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64596-388HAND SANITIZER (ALCOHOL) SOLUTION [GILCHRIST & SOAMES]1Legacy NDC, 1 package rows20200910_aee57f14-0b7b-9a8b-e053-2995a90a16de.zip
64596-388HAND SANITIZER (ALCOHOL) SOLUTION [GILCHRIST & SOAMES]1Legacy NDC, 1 package rows20200910_aee82720-9ddd-58f4-e053-2995a90adb38.zip
64596-388HAND SANITIZER (ALCOHOL) SOLUTION [GILCHRIST & SOAMES]1Legacy NDC, 1 package rows20200909_aed47652-038e-2aec-e053-2995a90acdf4.zip
64596-388HAND SANITIZER (ALCOHOL) SOLUTION [GILCHRIST & SOAMES]1Legacy NDC, 1 package rows20200910_aee86022-c868-ebb0-e053-2995a90aedcd.zip
64596-388HAND SANITIZER (ALCOHOL) SOLUTION [GILCHRIST & SOAMES]1Legacy NDC, 1 package rows20200910_aee5b33e-7d24-8db6-e053-2a95a90a073f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1997444ethanol 67 % Topical SolutionPSNaed47652-038e-2aec-e053-2995a90acdf41
1997444ethanol 67 % Topical SolutionPSNaee57f14-0b7b-9a8b-e053-2995a90a16de1
1997444ethanol 67 % Topical SolutionPSNaee5b33e-7d24-8db6-e053-2a95a90a073f1
1997444ethanol 67 % Topical SolutionPSNaee82720-9ddd-58f4-e053-2995a90adb381
1997444ethanol 67 % Topical SolutionPSNaee86022-c868-ebb0-e053-2995a90aedcd1
1997444ethanol 0.67 ML/ML Topical SolutionSCDaed47652-038e-2aec-e053-2995a90acdf41
1997444ethanol 0.67 ML/ML Topical SolutionSCDaee57f14-0b7b-9a8b-e053-2995a90a16de1
1997444ethanol 0.67 ML/ML Topical SolutionSCDaee5b33e-7d24-8db6-e053-2a95a90a073f1
1997444ethanol 0.67 ML/ML Topical SolutionSCDaee82720-9ddd-58f4-e053-2995a90adb381
1997444ethanol 0.67 ML/ML Topical SolutionSCDaee86022-c868-ebb0-e053-2995a90aedcd1
1997444ethanol 67 % Topical SolutionSYaed47652-038e-2aec-e053-2995a90acdf41
1997444ethanol 67 % Topical SolutionSYaee57f14-0b7b-9a8b-e053-2995a90a16de1
1997444ethanol 67 % Topical SolutionSYaee5b33e-7d24-8db6-e053-2a95a90a073f1
1997444ethanol 67 % Topical SolutionSYaee82720-9ddd-58f4-e053-2995a90adb381
1997444ethanol 67 % Topical SolutionSYaee86022-c868-ebb0-e053-2995a90aedcd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64596-388-086459603880824 mL in 1 BOTTLE, PLASTIC (64596-388-08) 24 ml2020-09-080000-00-00NoNoCurrent
64596-388-126459603881237 mL in 1 BOTTLE, PLASTIC (64596-388-12) 37 ml2020-09-080000-00-00NoNoCurrent
64596-388-1664596038816473 mL in 1 BOTTLE, PLASTIC (64596-388-16) 473 ml2020-09-080000-00-00NoNoCurrent
64596-388-3064596038830887 mL in 1 BOTTLE, PLASTIC (64596-388-30) 887 ml2020-09-080000-00-00NoNoCurrent
64596-388-88645960388883780 mL in 1 BOTTLE, PLASTIC (64596-388-88) 3780 ml2020-09-080000-00-00NoNoCurrent