Hand Sanitizer

Product NDC
64596-388
Requested package NDC
64596-388-08
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64596-38864596-388-08IInactivated 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#

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