PUROMA Instant Foaming Hand Sanitizer without Fragrance

Product NDC
80948-012
Requested package NDC
80948-012-10
11-digit product format
809480012
Labeler code
80948
Product ID
80948-012_d964ff60-84df-5e14-e053-2a95a90a520c
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
2021-03-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 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 packagepackage80948-01280948-012-10IInactivated 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
80948-012-01PUROMA Instant Foaming Hand Sanitizer without Fragrance60 mL in 1 BOTTLELIQUID603
80948-012-02PUROMA Instant Foaming Hand Sanitizer without Fragrance80 mL in 1 BOTTLELIQUID803
80948-012-03PUROMA Instant Foaming Hand Sanitizer without Fragrance100 mL in 1 BOTTLELIQUID1003
80948-012-04PUROMA Instant Foaming Hand Sanitizer without Fragrance150 mL in 1 BOTTLELIQUID1503
80948-012-05PUROMA Instant Foaming Hand Sanitizer without Fragrance220 mL in 1 PACKAGELIQUID2203
80948-012-06PUROMA Instant Foaming Hand Sanitizer without Fragrance250 mL in 1 BOTTLELIQUID2503
80948-012-07PUROMA Instant Foaming Hand Sanitizer without Fragrance300 mL in 1 BOTTLELIQUID3003
80948-012-08PUROMA Instant Foaming Hand Sanitizer without Fragrance350 mL in 1 BOTTLELIQUID3503
80948-012-09PUROMA Instant Foaming Hand Sanitizer without Fragrance5000 mL in 1 CANLIQUID50003
80948-012-10PUROMA Instant Foaming Hand Sanitizer without Fragrance50000 mL in 1 CANLIQUID500003
80948-012-11PUROMA Instant Foaming Hand Sanitizer without Fragrance200000 mL in 1 CANLIQUID2000003
80948-012-12PUROMA Instant Foaming Hand Sanitizer without Fragrance70 mL in 1 BOTTLELIQUID703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-012PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 12 package rows20231215_ae3d334f-66d7-49e3-b584-bebf1eae6ab4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098198ethanol 75 % Topical FoamPSNae3d334f-66d7-49e3-b584-bebf1eae6ab43
1098198ethanol 0.75 ML/ML Topical FoamSCDae3d334f-66d7-49e3-b584-bebf1eae6ab43
1098198ethanol 75 % Topical FoamSYae3d334f-66d7-49e3-b584-bebf1eae6ab43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-012-108094800121050000 mL in 1 CAN (80948-012-10) 50000 ml2021-04-060000-00-00NoNoCurrent