FDA.reportPublic FDA data

NDC 83584-116 - Hand sanitizer

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83584-116
Package NDCs from labels
83584-116-01, 83584-116-02
Manufacturer
PurCel Labs LLC | Jiangsu Intco Medical Products Co., Ltd
Effective date
2023-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hand sanitizer - PurCel Labs LLC | Jiangsu Intco Medical Products Co., LtdPurCel Labs LLC | Jiangsu Intco Medical Products Co., Ltd2023-08-20HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83584-116-022025-01-30C16284748780-12cef2736-73f3-d83d-e063-dadaa90ab31f01c826ab-464c-98e2-e063-6394a90aba20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83584-116-01Hand sanitizer473 mL in 1 BOTTLE, PUMPGEL4733
83584-116-02Hand sanitizer30 in 1 CARTONGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83584-116HAND SANITIZER (ALCOHOL) GEL [PURCEL LABS LLC]32 package rows20230821_01c826ab-464c-98e2-e063-6394a90aba20.zip