PFP POLYclean Hand Sanitizer - Gel 72

Product NDC
77034-004
Requested package NDC
77034-004-01
11-digit product format
770340004
Labeler code
77034
Product ID
77034-004_d3e07109-486b-4467-bc39-8966ab157398
Type
HUMAN OTC DRUG
Nonproprietary name
Gel Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Pfp Industries, LLC (a Global Enterprise)
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-23
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
72 L/100L
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 packagepackage77034-00477034-004-01IInactivated by FDA2026-10-16

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…

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77034-004-012023-01-30C16284748780-1f386c649-b8e2-0266-e053-dadaa90a7c1aPFP POLYclean Hand Sanitizer - Gel 72

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77034-004-01PFP POLYclean Hand Sanitizer - Gel 721217 L in 1 TANKGEL12171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77034-004PFP POLYCLEAN HAND SANITIZER - GEL 72 (GEL HAND SANITIZER) GEL [PFP INDUSTRIES, LLC (A GLOBAL ENTERPRISE)]1Legacy NDC, 1 package rows20200823_2c96651f-71ed-4b4f-9a64-8a819f46aab8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2277550ethanol 72 % Topical GelPSN2c96651f-71ed-4b4f-9a64-8a819f46aab81
2277550ethanol 0.72 ML/ML Topical GelSCD2c96651f-71ed-4b4f-9a64-8a819f46aab81
2277550ethanol 72 % Topical GelSY2c96651f-71ed-4b4f-9a64-8a819f46aab81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77034-004-01770340004011217 L in 1 TANK (77034-004-01) 1217 l2020-07-230000-00-00NoNoCurrent