f(x)l Skin Care Hand Sanitizer

Product NDC
65113-1001
Requested package NDC
65113-1001-4
11-digit product format
651131001
Labeler code
65113
Product ID
65113-1001_d8f5d967-901c-447f-9436-54ef4b29b317
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
G.S. COSMECEUTICAL USA, INC.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-15
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage65113-100165113-1001-4IInactivated 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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
65113-1001-1f(x)l Skin Care Hand Sanitizer118 mL in 1 BOTTLEGEL1182
65113-1001-2f(x)l Skin Care Hand Sanitizer237 mL in 1 BOTTLEGEL2372
65113-1001-3f(x)l Skin Care Hand Sanitizer473 mL in 1 BOTTLEGEL4732
65113-1001-4f(x)l Skin Care Hand Sanitizer946 mL in 1 BOTTLEGEL9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-1001F(X)L SKIN CARE HAND SANITIZER (ALCOHOL) GEL [G.S. COSMECEUTICAL USA, INC.]2Legacy NDC, 4 package rows20220107_7023eea3-cedd-462d-a718-b2277c16b6b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN7023eea3-cedd-462d-a718-b2277c16b6b62
581662ethanol 0.7 ML/ML Topical GelSCD7023eea3-cedd-462d-a718-b2277c16b6b62
581662ethanol 70 % Topical GelSY7023eea3-cedd-462d-a718-b2277c16b6b62
581662ethyl alcohol 70 % Topical GelSY7023eea3-cedd-462d-a718-b2277c16b6b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65113-1001-465113100104946 mL in 1 BOTTLE (65113-1001-4) 946 ml2020-05-150000-00-00NoNoCurrent