FDA.reportPublic FDA data

Paume Moisturizing Antibacterial Hand Gel

Product NDC
80328-409
Requested package NDC
80328-409-02
11-digit product format
803280409
Labeler code
80328
Product ID
80328-409_e87d57c0-23af-9db6-e053-2995a90a53de
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Paume Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-04
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
69 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage80328-40980328-409-02IInactivated 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80328-40980328-409-02IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80328-40980328-409-02IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
80328-409-012025-07-29C16284748780-13b156c62-3058-fb37-e063-e6dba90a4e07ae6d4099-de48-9704-e053-2a95a90a5889
80328-409-022025-07-29C16284748780-13b156c62-3058-fb37-e063-e6dba90a4e07ae6d4099-de48-9704-e053-2a95a90a5889

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80328-409-01Paume Moisturizing Antibacterial Hand Gel90 mL in 1 BOTTLEGEL904
80328-409-02Paume Moisturizing Antibacterial Hand Gel500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80328-409PAUME MOISTURIZING ANTIBACTERIAL HAND GEL (ALCOHOL) GEL [PAUME INC]4Legacy NDC, 2 package rows20240127_ae6d4099-de48-9704-e053-2a95a90a5889.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287763ethanol 69 % Topical GelPSNae6d4099-de48-9704-e053-2a95a90a58894
2287763ethanol 0.69 ML/ML Topical GelSCDae6d4099-de48-9704-e053-2a95a90a58894
2287763ethanol 69 % Topical GelSYae6d4099-de48-9704-e053-2a95a90a58894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80328-409-0280328040902500 mL in 1 BOTTLE (80328-409-02) 500 ml2020-09-040000-00-00NoNoCurrent