Hand Sanitizer

Product NDC
74128-080
Requested package NDC
74128-080-16
11-digit product format
741280080
Labeler code
74128
Product ID
74128-080_a7dcab72-e6b8-dc35-e053-2995a90a270a
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Tekkware, Inc. d.b.a. Gloucester Bio
Application
part356
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 packagepackage74128-08074128-080-16IInactivated 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 · 18 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…

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
74128-080-012022-01-28C16284748780-1d6a99b39-4028-a426-e053-dadaa90af4c2a22ca66a-44e6-efcc-e053-2995a90a027c
74128-080-162022-01-28C16284748780-1d6a99b39-4028-a426-e053-dadaa90af4c2a22ca66a-44e6-efcc-e053-2995a90a027c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74128-080-01Hand Sanitizer3785 mL in 1 BOTTLESPRAY37854
74128-080-16Hand Sanitizer473 mL in 1 BOTTLESPRAY4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74128-080HAND SANITIZER (ETHYL ALCOHOL) SPRAY [TEKKWARE, INC. D.B.A. GLOUCESTER BIO]4Legacy NDC, 2 package rows20200613_a22ca66a-44e6-efcc-e053-2995a90a027c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1241663ethanol 80 % Topical SprayPSNa22ca66a-44e6-efcc-e053-2995a90a027c4
1241663ethanol 0.8 ML/ML Topical SpraySCDa22ca66a-44e6-efcc-e053-2995a90a027c4
1241663ethanol 80 % Topical SpraySYa22ca66a-44e6-efcc-e053-2995a90a027c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74128-080-1674128008016473 mL in 1 BOTTLE (74128-080-16) 473 ml2020-03-300000-00-00NoNoCurrent