FDA.reportPublic FDA data

HAND SANITIZER

Product NDC
75613-016
Requested package NDC
75613-016-01
11-digit product format
756130016
Labeler code
75613
Product ID
75613-016_dbaebd13-eea2-45b1-a59a-034087e5feee
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Ningbo Lanzi Cosmetic Technology Co., Ltd
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-19
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
68 mL/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage75613-01675613-016-01IInactivated by FDA2026-10-12

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
75613-016-012023-01-30C16284748780-1f386c64a-2352-0266-e053-dadaa90a7c1aHAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75613-016-01HAND SANITIZER10 mL in 1 BOTTLELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75613-016HAND SANITIZER (ETHYL ALCOHOL) LIQUID [NINGBO LANZI COSMETIC TECHNOLOGY CO., LTD]1Legacy NDC, 1 package rows20210220_a5cf768d-c58f-4309-a563-cba7cb78d736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286291ethanol 68 % Topical SolutionPSNa5cf768d-c58f-4309-a563-cba7cb78d7361
2286291ethanol 0.68 ML/ML Topical SolutionSCDa5cf768d-c58f-4309-a563-cba7cb78d7361
2286291ethanol 68 % Topical SolutionSYa5cf768d-c58f-4309-a563-cba7cb78d7361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75613-016-017561300160110 mL in 1 BOTTLE (75613-016-01) 10 ml2021-02-190000-00-00NoNoCurrent