Hygieni-Klean Hand Sanitizer Gel Healthcare Grade

Product NDC
78174-043
Requested package NDC
78174-043-07
11-digit product format
781740043
Labeler code
78174
Product ID
78174-043_363a9665-3332-4347-ad32-f4ead082bc3c
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Custom Chemical Services, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-09
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 L/100L
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 packagepackage78174-04378174-043-07IInactivated by FDA2026-09-14

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…

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
78174-043-01Hygieni-Klean Hand Sanitizer Gel Healthcare Grade3.78541 L in 1 JUGGEL3.785412
78174-043-02Hygieni-Klean Hand Sanitizer Gel Healthcare Grade0.946353 L in 1 BOTTLEGEL0.9463532
78174-043-03Hygieni-Klean Hand Sanitizer Gel Healthcare Grade0.473176 L in 1 BOTTLEGEL0.4731762
78174-043-04Hygieni-Klean Hand Sanitizer Gel Healthcare Grade0.354882 L in 1 BOTTLEGEL0.3548822
78174-043-05Hygieni-Klean Hand Sanitizer Gel Healthcare Grade0.236588 L in 1 BOTTLEGEL0.2365882
78174-043-06Hygieni-Klean Hand Sanitizer Gel Healthcare Grade0.118294 L in 1 BOTTLEGEL0.1182942
78174-043-07Hygieni-Klean Hand Sanitizer Gel Healthcare Grade0.0591471 L in 1 BOTTLEGEL0.05914712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78174-043HYGIENI-KLEAN HAND SANITIZER GEL HEALTHCARE GRADE (ALCOHOL) GEL [CUSTOM CHEMICAL SERVICES, LLC]2Legacy NDC, 7 package rows20210219_0799a6c7-a5ae-4dd6-a281-d363350c9d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSN0799a6c7-a5ae-4dd6-a281-d363350c9d0f2
1041498ethanol 0.8 ML/ML Topical GelSCD0799a6c7-a5ae-4dd6-a281-d363350c9d0f2
1041498ethanol 80 % Topical GelSY0799a6c7-a5ae-4dd6-a281-d363350c9d0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78174-043-0778174004307.0591471 L in 1 BOTTLE (78174-043-07) 2021-01-090000-00-00NoNoCurrent