Home NDC 80328-409 Paume Moisturizing Antibacterial Hand Gel
Product NDC 80328-409
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 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 80328-409-02 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 80328-409-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 80328-409-02 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 80328-409-01 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80328-409-01 Paume Moisturizing Antibacterial Hand Gel 90 mL in 1 BOTTLE GEL 90 4 80328-409-02 Paume Moisturizing Antibacterial Hand Gel 500 mL in 1 BOTTLE GEL 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80328-409 PAUME MOISTURIZING ANTIBACTERIAL HAND GEL (ALCOHOL) GEL [PAUME INC] 4 Legacy NDC, 2 package rows 20240127_ae6d4099-de48-9704-e053-2a95a90a5889.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80328-409-01 80328040901 90 mL in 1 BOTTLE (80328-409-01) 90 ml 2020-09-04 0000-00-00 No No Current 80328-409-02 80328040902 500 mL in 1 BOTTLE (80328-409-02) 500 ml 2020-09-04 0000-00-00 No No Current