FDA.reportPublic FDA data

PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance

Product NDC
80948-017
Requested package NDC
80948-017-13
11-digit product format
809480017
Labeler code
80948
Product ID
80948-017_d1787718-8aa2-58c0-e053-2995a90a1568
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-05
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 packagepackage80948-01780948-017-13IInactivated 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-01780948-017-13IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-01780948-017-13IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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, Effective, Related label table
NDCEffectiveRelated label
80948-017-012025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-022025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-032025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-042025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-052025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-062025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-072025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-082025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-092025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-102025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-112025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-122025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-132025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-142025-07-29d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-012023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-022023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-032023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-042023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-052023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-062023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-072023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-082023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-092023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-102023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-112023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-122023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-132023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-142023-12-28d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-012023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-022023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-032023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-042023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-052023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-062023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-072023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-082023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-092023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-102023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-112023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-122023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-132023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
80948-017-142023-01-30d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-017-01PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance10 in 1 PACKAGELIQUID104
80948-017-01PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance66 mL in 1 PACKAGELIQUID664
80948-017-02PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance132 mL in 1 PACKAGELIQUID1324
80948-017-02PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance20 in 1 PACKAGELIQUID204
80948-017-03PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance40 in 1 PACKAGELIQUID404
80948-017-03PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance264 mL in 1 PACKAGELIQUID2644
80948-017-04PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance528 mL in 1 PACKAGELIQUID5284
80948-017-04PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance80 in 1 PACKAGELIQUID804
80948-017-05PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance792 mL in 1 PACKAGELIQUID7924
80948-017-05PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance120 in 1 PACKAGELIQUID1204
80948-017-06PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance350 mL in 1 PACKAGELIQUID3504
80948-017-06PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance50 in 1 CANISTERLIQUID504
80948-017-07PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance700 mL in 1 CANISTERLIQUID7004
80948-017-07PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance100 in 1 CANISTERLIQUID1004
80948-017-08PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance10 in 1 POUCHLIQUID104
80948-017-08PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance66 mL in 1 POUCHLIQUID664
80948-017-09PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance20 in 1 POUCHLIQUID204
80948-017-09PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance132 mL in 1 POUCHLIQUID1324
80948-017-10PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance40 in 1 POUCHLIQUID404
80948-017-10PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance264 mL in 1 POUCHLIQUID2644
80948-017-11PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance528 mL in 1 CANISTERLIQUID5284
80948-017-11PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance80 in 1 CANISTERLIQUID804
80948-017-12PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance120 in 1 CANISTERLIQUID1204
80948-017-12PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance792 mL in 1 CANISTERLIQUID7924
80948-017-13PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance50 in 1 CANISTERLIQUID504
80948-017-13PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance330 mL in 1 CANISTERLIQUID3304
80948-017-14PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance100 in 1 CANISTERLIQUID1004
80948-017-14PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance660 mL in 1 CANISTERLIQUID6604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-017PUROMA HAND SANITIZER WIPE ALCOHOL FREE WITH FRAGRANCE (BENZALKONIUM CHLORIDE) LIQUID [ZENITH MICRO CONTROL]4Legacy NDC, 28 package rows20240202_d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-017-138094800171350 NOT APPLICABLE in 1 CANISTER (80948-017-13) > 6.6 mL in 1 NOT APPLICABLE50 not applicable2021-10-190000-00-00NoNoCurrent