PFP POLYClean Hand Sanitizer - Gel 70

Product NDC
77034-002
Requested package NDC
77034-002-01
11-digit product format
770340002
Labeler code
77034
Product ID
77034-002_21326cb0-6264-4f3d-9e15-33bd25d20169
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
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
70 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 packagepackage77034-00277034-002-01IInactivated 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 · 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77034-002-012023-01-30C16284748780-1f386c64a-3484-0266-e053-dadaa90a7c1aPFP POLYClean Hand Sanitizer - Gel 70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77034-002-01PFP POLYClean Hand Sanitizer - Gel 701217 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77034-002PFP POLYCLEAN HAND SANITIZER - GEL 70 (ETHYL ALCOHOL) GEL [PFP INDUSTRIES, LLC (A GLOBAL ENTERPRISE)]1Legacy NDC, 1 package rows20200807_ec5c3826-154b-4c90-9db7-92228e83c3a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNab897e8b-288c-a828-e053-2995a90a6b671
581662ethanol 70 % Topical GelPSNec5c3826-154b-4c90-9db7-92228e83c3a91
581662ethanol 0.7 ML/ML Topical GelSCDab897e8b-288c-a828-e053-2995a90a6b671
581662ethanol 0.7 ML/ML Topical GelSCDec5c3826-154b-4c90-9db7-92228e83c3a91
581662ethanol 70 % Topical GelSYab897e8b-288c-a828-e053-2995a90a6b671
581662ethanol 70 % Topical GelSYec5c3826-154b-4c90-9db7-92228e83c3a91
581662ethyl alcohol 70 % Topical GelSYab897e8b-288c-a828-e053-2995a90a6b671
581662ethyl alcohol 70 % Topical GelSYec5c3826-154b-4c90-9db7-92228e83c3a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77034-002-01770340002011217 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (77034-002-01) 1217 l2020-07-230000-00-00NoNoCurrent