FDA.reportPublic FDA data

PFP POLYClean Hand Sanitizer - Gel 70 IPA

Product NDC
77034-008
Requested package NDC
77034-008-01
11-digit product format
770340008
Labeler code
77034
Product ID
77034-008_7fbf86d4-4a2f-4136-a486-ecfb2a0840c6
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl 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
ISOPROPYL 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 packagepackage77034-00877034-008-01IInactivated by FDA2026-09-09

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77034-008-012023-01-30C16284748780-1f386c64a-33ee-0266-e053-dadaa90a7c1aPFP POLYClean Hand Sanitizer - Gel 70 IPA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77034-008-01PFP POLYClean Hand Sanitizer - Gel 70 IPA1217 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77034-008PFP POLYCLEAN HAND SANITIZER - GEL 70 IPA (ISOPROPYL ALCOHOL) GEL [PFP INDUSTRIES, LLC (A GLOBAL ENTERPRISE)]1Legacy NDC, 1 package rows20200807_b45801d8-1318-42a8-964c-0ebb38918842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581698isopropyl alcohol 70 % Topical GelPSNb45801d8-1318-42a8-964c-0ebb389188421
581698isopropyl alcohol 0.7 ML/ML Topical GelSCDb45801d8-1318-42a8-964c-0ebb389188421
581698isopropyl alcohol 70 % Topical GelSYb45801d8-1318-42a8-964c-0ebb389188421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77034-008-01770340008011217 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (77034-008-01) 1217 l2020-07-230000-00-00NoNoCurrent