FDA.reportPublic FDA data

PUROMA Hand Sanitizer Wipe Alcohol Free

Product NDC
80948-011
Requested package NDC
80948-011-03
11-digit product format
809480011
Labeler code
80948
Product ID
80948-011_beb3ee97-d960-3a44-e053-2995a90ab260
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-12
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
130 mg/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 packagepackage80948-01180948-011-03IInactivated 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80948-011-01af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-02af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-03af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-04af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-05af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-06af8f7588-93f8-491d-8c2b-6ef31c199027
80948-011-07af8f7588-93f8-491d-8c2b-6ef31c199027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-011-01PUROMA Hand Sanitizer Wipe Alcohol Free66 mL in 1 PACKAGECLOTH662
80948-011-01PUROMA Hand Sanitizer Wipe Alcohol Free10 in 1 PACKAGECLOTH102
80948-011-02PUROMA Hand Sanitizer Wipe Alcohol Free132 mL in 1 PACKAGECLOTH1322
80948-011-02PUROMA Hand Sanitizer Wipe Alcohol Free20 in 1 PACKAGECLOTH202
80948-011-03PUROMA Hand Sanitizer Wipe Alcohol Free40 in 1 PACKAGECLOTH402
80948-011-03PUROMA Hand Sanitizer Wipe Alcohol Free264 mL in 1 PACKAGECLOTH2642
80948-011-04PUROMA Hand Sanitizer Wipe Alcohol Free80 in 1 PACKAGECLOTH802
80948-011-04PUROMA Hand Sanitizer Wipe Alcohol Free528 mL in 1 PACKAGECLOTH5282
80948-011-05PUROMA Hand Sanitizer Wipe Alcohol Free120 in 1 PACKAGECLOTH1202
80948-011-05PUROMA Hand Sanitizer Wipe Alcohol Free792 mL in 1 PACKAGECLOTH7922
80948-011-06PUROMA Hand Sanitizer Wipe Alcohol Free350 mL in 1 CANISTERCLOTH3502
80948-011-06PUROMA Hand Sanitizer Wipe Alcohol Free50 in 1 CANISTERCLOTH502
80948-011-07PUROMA Hand Sanitizer Wipe Alcohol Free700 mL in 1 CANISTERCLOTH7002
80948-011-07PUROMA Hand Sanitizer Wipe Alcohol Free100 in 1 CANISTERCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-011PUROMA HAND SANITIZER WIPE ALCOHOL FREE (BENZALKONIUM CHLORIDE) CLOTH [ZENITH MICRO CONTROL]2Legacy NDC, 14 package rows20231215_af8f7588-93f8-491d-8c2b-6ef31c199027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNaf8f7588-93f8-491d-8c2b-6ef31c1990272
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDaf8f7588-93f8-491d-8c2b-6ef31c1990272
1038558benzalkonium chloride 0.13 % Topical ClothSYaf8f7588-93f8-491d-8c2b-6ef31c1990272
1038558benzalkonium chloride 0.13 % Topical SwabSYaf8f7588-93f8-491d-8c2b-6ef31c1990272
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYaf8f7588-93f8-491d-8c2b-6ef31c1990272
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYaf8f7588-93f8-491d-8c2b-6ef31c1990272
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYaf8f7588-93f8-491d-8c2b-6ef31c1990272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-011-038094800110340 PACKAGE in 1 PACKAGE (80948-011-03) > 264 mL in 1 PACKAGE40 package2021-03-120000-00-00NoNoCurrent