FDA.reportPublic FDA data

LACTONE HAND SANITIZER

Product NDC
75348-606
Requested package NDC
75348-606-38
11-digit product format
753480606
Labeler code
75348
Product ID
75348-606_aa7ebce0-afb0-5d9e-e053-2995a90ac42d
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 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 packagepackage75348-60675348-606-38IInactivated 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 · 19 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
75348-606-01c7ccaba7-181e-fd44-e053-dadaa90aa01bHand Sanitizer 606
75348-606-02c7ccaba7-17ca-fd44-e053-dadaa90aa01bHand Sanitizer
75348-606-04c7ccaba7-17ca-fd44-e053-dadaa90aa01bHand Sanitizer
75348-606-05c7ccaba7-1374-fd44-e053-dadaa90aa01bLACTONE HAND SANITIZER
75348-606-08c7ccaba7-17ca-fd44-e053-dadaa90aa01bHand Sanitizer
75348-606-10c7ccaba7-1374-fd44-e053-dadaa90aa01bLACTONE HAND SANITIZER
75348-606-16c7ccaba7-17ca-fd44-e053-dadaa90aa01bHand Sanitizer
75348-606-19c7ccaba7-1101-fd44-e053-dadaa90aa01bHand sanitizer 606 gallon
75348-606-25c7ccaba7-1374-fd44-e053-dadaa90aa01bLACTONE HAND SANITIZER
75348-606-32c7ccaba7-17ca-fd44-e053-dadaa90aa01bHand Sanitizer
75348-606-38c7ccaba7-1101-fd44-e053-dadaa90aa01bHand sanitizer 606 gallon
75348-606-50c7ccaba7-181e-fd44-e053-dadaa90aa01bHand Sanitizer 606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75348-606-02LACTONE HAND SANITIZER59 mL in 1 BOTTLE, PLASTICGEL597
75348-606-04LACTONE HAND SANITIZER118 mL in 1 BOTTLE, PLASTICGEL1187
75348-606-08LACTONE HAND SANITIZER236 mL in 1 BOTTLE, PLASTICGEL2367
75348-606-16LACTONE HAND SANITIZER473 mL in 1 BOTTLE, PLASTICGEL4737
75348-606-32LACTONE HAND SANITIZER946 mL in 1 BOTTLE, PLASTICGEL9467
75348-606-01LACTONE HAND SANITIZER1000 mL in 1 BOTTLE, PLASTICGEL10001
75348-606-05LACTONE HAND SANITIZER50 mL in 1 BOTTLEGEL501
75348-606-10LACTONE HAND SANITIZER100 mL in 1 BOTTLEGEL1001
75348-606-19LACTONE HAND SANITIZER19000 mL in 1 BOTTLE, PLASTICGEL190001
75348-606-25LACTONE HAND SANITIZER250 mL in 1 BOTTLEGEL2501
75348-606-38LACTONE HAND SANITIZER3800 mL in 1 BOTTLE, PLASTICGEL38001
75348-606-50LACTONE HAND SANITIZER500 mL in 1 BOTTLE, PLASTICGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75348-606LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]7Legacy NDC, 5 package rows20200607_a33959b4-3d50-290f-e053-2a95a90a460b.zip
75348-606LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]1Legacy NDC, 2 package rows20200715_aa74394e-f181-2ab5-e053-2995a90a6fef.zip
75348-606LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]1Legacy NDC, 2 package rows20200716_aa7ebce0-afbe-5d9e-e053-2995a90ac42d.zip
75348-606LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]1Legacy NDC, 3 package rows20200425_b996b2fb-59db-4435-8b21-f11baf6de491.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSNa33959b4-3d50-290f-e053-2a95a90a460b7
1041498ethanol 0.8 ML/ML Topical GelSCDa33959b4-3d50-290f-e053-2a95a90a460b7
1041498ethanol 80 % Topical GelSYa33959b4-3d50-290f-e053-2a95a90a460b7
1041498ethanol 80 % Topical GelPSNaa74394e-f181-2ab5-e053-2995a90a6fef1
1041498ethanol 80 % Topical GelPSNaa7ebce0-afbe-5d9e-e053-2995a90ac42d1
1041498ethanol 80 % Topical GelPSNb996b2fb-59db-4435-8b21-f11baf6de4911
1041498ethanol 0.8 ML/ML Topical GelSCDaa74394e-f181-2ab5-e053-2995a90a6fef1
1041498ethanol 0.8 ML/ML Topical GelSCDaa7ebce0-afbe-5d9e-e053-2995a90ac42d1
1041498ethanol 0.8 ML/ML Topical GelSCDb996b2fb-59db-4435-8b21-f11baf6de4911
1041498ethanol 80 % Topical GelSYaa74394e-f181-2ab5-e053-2995a90a6fef1
1041498ethanol 80 % Topical GelSYaa7ebce0-afbe-5d9e-e053-2995a90ac42d1
1041498ethanol 80 % Topical GelSYb996b2fb-59db-4435-8b21-f11baf6de4911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75348-606-38753480606383800 mL in 1 BOTTLE, PLASTIC (75348-606-38) 3800 ml2020-03-300000-00-00NoNoCurrent