FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
80378-001
Requested package NDC
80378-001-00
11-digit product format
803780001
Labeler code
80378
Product ID
80378-001_c20f4caa-b2c3-0aa4-e053-2a95a90a45ba
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
CLOTH
Route
TOPICAL
Labeler
THE SECUREPHARMA PARTNERSHIP SRL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
75 mL/100mL
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 packagepackage80378-00180378-001-00IInactivated by FDA2026-08-03

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 · 16 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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80378-001-002022-07-29C16284748780-1e4f33bdf-b2b9-d8a0-e053-dadaa90a6e4eada393b0-4fd9-1436-e053-2995a90a13e3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80378-001-00Hand Sanitizer50 mL in 1 CASECLOTH502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80378-001HAND SANITIZER (ISOPROPYL ALCOHOL) CLOTH [THE SECUREPHARMA PARTNERSHIP SRL]2Legacy NDC, 1 package rows20210512_ada393b0-4fd9-1436-e053-2995a90a13e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287160isopropyl alcohol 75 % Medicated PadPSNada393b0-4fd9-1436-e053-2995a90a13e32
2287160isopropyl alcohol 0.75 ML/ML Medicated PadSCDada393b0-4fd9-1436-e053-2995a90a13e32
2287160isopropyl alcohol 75 % Topical ClothSYada393b0-4fd9-1436-e053-2995a90a13e32
2287160isopropyl alcohol 75 % Topical SwabSYada393b0-4fd9-1436-e053-2995a90a13e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80378-001-008037800010050 mL in 1 CASE (80378-001-00) 50 ml2020-03-300000-00-00NoNoCurrent