PUROMA Hand sanitizer

Product NDC
80948-003
Requested package NDC
80948-003-07
11-digit product format
809480003
Labeler code
80948
Product ID
80948-003_d1776459-0b09-e894-e053-2995a90af8a4
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-20
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage80948-00380948-003-07IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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 NDCProductDescriptionFormQuantityStrengthSPL version
80948-003-01PUROMA Hand sanitizer30 mL in 1 BOTTLELIQUID304
80948-003-02PUROMA Hand sanitizer60 mL in 1 BOTTLELIQUID604
80948-003-03PUROMA Hand sanitizer50 mL in 1 BOTTLELIQUID504
80948-003-04PUROMA Hand sanitizer100 mL in 1 BOTTLELIQUID1004
80948-003-05PUROMA Hand sanitizer200 mL in 1 BOTTLELIQUID2004
80948-003-06PUROMA Hand sanitizer250 mL in 1 BOTTLELIQUID2504
80948-003-07PUROMA Hand sanitizer500 mL in 1 BOTTLELIQUID5004
80948-003-08PUROMA Hand sanitizer1000 mL in 1 BOTTLELIQUID10004
80948-003-09PUROMA Hand sanitizer5000 mL in 1 CANLIQUID50004
80948-003-10PUROMA Hand sanitizer50 mL in 1 BOTTLELIQUID504
80948-003-10PUROMA Hand sanitizer12 in 1 PACKAGELIQUID124
80948-003-11PUROMA Hand sanitizer100 mL in 1 BOTTLELIQUID1004
80948-003-11PUROMA Hand sanitizer6 in 1 PACKAGELIQUID64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-003PUROMA HAND SANITIZER (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]4Legacy NDC, 13 package rows20231214_7c76cf3c-443d-4918-b12a-869ff665e229.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-003-0780948000307500 mL in 1 BOTTLE (80948-003-07) 500 ml2020-12-200000-00-00NoNoCurrent