Elyptol Antimicrobial Hand Gel

Product NDC
69343-121
Requested package NDC
69343-121-15
11-digit product format
693430121
Labeler code
69343
Product ID
69343-121_850f0387-d884-4ef1-9ee6-36661c4fcde4
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
Elyptol Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
7 mL/10mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage69343-12169343-121-15IInactivated by FDA2026-11-10

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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69343-121-02Elyptol Antimicrobial Hand Gel59 mL in 1 BOTTLEGEL596
69343-121-02Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-03Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-03Elyptol Antimicrobial Hand Gel89 mL in 1 PACKAGEGEL896
69343-121-08Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-08Elyptol Antimicrobial Hand Gel236 mL in 1 BOTTLEGEL2366
69343-121-15Elyptol Antimicrobial Hand Gel15 mL in 1 BOTTLEGEL156
69343-121-15Elyptol Antimicrobial Hand Gel24 in 1 CARTONGEL246
69343-121-16Elyptol Antimicrobial Hand Gel473 mL in 1 BOTTLEGEL4736
69343-121-16Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-33Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-33Elyptol Antimicrobial Hand Gel1000 mL in 1 BOTTLEGEL10006
69343-121-34Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-34Elyptol Antimicrobial Hand Gel1005 mL in 1 BOTTLEGEL10056
69343-121-42Elyptol Antimicrobial Hand Gel1 in 1 CARTONGEL16
69343-121-42Elyptol Antimicrobial Hand Gel1250 mL in 1 BOTTLEGEL12506
69343-121-62Elyptol Antimicrobial Hand Gel6 in 1 CARTONGEL66
69343-121-62Elyptol Antimicrobial Hand Gel59 mL in 1 BOTTLEGEL596

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69343-121ELYPTOL ANTIMICROBIAL HAND GEL (ETHANOL) GEL [ELYPTOL INC.]6Legacy NDC, 18 package rows20230105_13c3e7c7-7310-4330-a728-a7a3e32d3325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN13c3e7c7-7310-4330-a728-a7a3e32d33256
581662ethanol 0.7 ML/ML Topical GelSCD13c3e7c7-7310-4330-a728-a7a3e32d33256
581662ethanol 70 % Topical GelSY13c3e7c7-7310-4330-a728-a7a3e32d33256
581662ethyl alcohol 70 % Topical GelSY13c3e7c7-7310-4330-a728-a7a3e32d33256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69343-121-156934301211524 BOTTLE in 1 CARTON (69343-121-15) > 15 mL in 1 BOTTLE24 bottle2020-11-130000-00-00NoNoCurrent