FDA.reportPublic FDA data

PUROMA Foaming Hand Alcohol Free Fragrance Free

Product NDC
80948-007
Requested package NDC
80948-007-39
11-digit product format
809480007
Labeler code
80948
Product ID
80948-007_d964632f-45d2-9500-e053-2995a90a992d
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
2021-03-10
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
130 mg/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 packagepackage80948-00780948-007-39IInactivated 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
80948-007-02ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-03ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-06ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-07ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-09ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-11ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-12ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-15ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-16ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-19ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-21ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-22ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-24ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-25ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-27ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-28ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-29ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-30ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-31ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-32ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-33ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-34ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-35ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-37ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-38ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-42ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-43ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-44ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-45ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-46ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-49ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-50ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-51ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-53ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-54ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-55ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-56ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-57ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-58ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-62ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-63ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-64ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-65ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-66ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-67ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-68ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-69ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-71ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-73ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27
80948-007-74ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-007-01PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-01PUROMA Foaming Hand Alcohol Free Fragrance Free60 mL in 1 PACKAGELIQUID604
80948-007-02PUROMA Foaming Hand Alcohol Free Fragrance Free60 mL in 1 PACKAGELIQUID604
80948-007-02PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-03PUROMA Foaming Hand Alcohol Free Fragrance Free60 mL in 1 PACKAGELIQUID604
80948-007-03PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-04PUROMA Foaming Hand Alcohol Free Fragrance Free60 mL in 1 PACKAGELIQUID604
80948-007-04PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-05PUROMA Foaming Hand Alcohol Free Fragrance Free60 mL in 1 PACKAGELIQUID604
80948-007-05PUROMA Foaming Hand Alcohol Free Fragrance Free48 in 1 PACKAGELIQUID484
80948-007-06PUROMA Foaming Hand Alcohol Free Fragrance Free70 mL in 1 BOTTLELIQUID704
80948-007-06PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-07PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-07PUROMA Foaming Hand Alcohol Free Fragrance Free70 mL in 1 BOTTLELIQUID704
80948-007-08PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-08PUROMA Foaming Hand Alcohol Free Fragrance Free70 mL in 1 BOTTLELIQUID704
80948-007-09PUROMA Foaming Hand Alcohol Free Fragrance Free70 mL in 1 BOTTLELIQUID704
80948-007-09PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-10PUROMA Foaming Hand Alcohol Free Fragrance Free70 mL in 1 BOTTLELIQUID704
80948-007-10PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-11PUROMA Foaming Hand Alcohol Free Fragrance Free48 in 1 PACKAGELIQUID484
80948-007-11PUROMA Foaming Hand Alcohol Free Fragrance Free70 mL in 1 BOTTLELIQUID704
80948-007-12PUROMA Foaming Hand Alcohol Free Fragrance Free80 mL in 1 BOTTLELIQUID804
80948-007-12PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-13PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-13PUROMA Foaming Hand Alcohol Free Fragrance Free80 mL in 1 BOTTLELIQUID804
80948-007-14PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-14PUROMA Foaming Hand Alcohol Free Fragrance Free80 mL in 1 BOTTLELIQUID804
80948-007-15PUROMA Foaming Hand Alcohol Free Fragrance Free80 mL in 1 BOTTLELIQUID804
80948-007-15PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-16PUROMA Foaming Hand Alcohol Free Fragrance Free80 mL in 1 BOTTLELIQUID804
80948-007-16PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-17PUROMA Foaming Hand Alcohol Free Fragrance Free48 in 1 PACKAGELIQUID484
80948-007-17PUROMA Foaming Hand Alcohol Free Fragrance Free80 mL in 1 BOTTLELIQUID804
80948-007-18PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-18PUROMA Foaming Hand Alcohol Free Fragrance Free100 mL in 1 BOTTLELIQUID1004
80948-007-19PUROMA Foaming Hand Alcohol Free Fragrance Free100 mL in 1 BOTTLELIQUID1004
80948-007-19PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-20PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-20PUROMA Foaming Hand Alcohol Free Fragrance Free100 mL in 1 BOTTLELIQUID1004
80948-007-21PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-21PUROMA Foaming Hand Alcohol Free Fragrance Free100 mL in 1 BOTTLELIQUID1004
80948-007-22PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-22PUROMA Foaming Hand Alcohol Free Fragrance Free100 mL in 1 BOTTLELIQUID1004
80948-007-23PUROMA Foaming Hand Alcohol Free Fragrance Free48 in 1 PACKAGELIQUID484
80948-007-23PUROMA Foaming Hand Alcohol Free Fragrance Free100 mL in 1 BOTTLELIQUID1004
80948-007-24PUROMA Foaming Hand Alcohol Free Fragrance Free150 mL in 1 BOTTLELIQUID1504
80948-007-24PUROMA Foaming Hand Alcohol Free Fragrance Free2 in 1 PACKAGELIQUID24
80948-007-25PUROMA Foaming Hand Alcohol Free Fragrance Free150 mL in 1 BOTTLELIQUID1504
80948-007-25PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-26PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-26PUROMA Foaming Hand Alcohol Free Fragrance Free150 mL in 1 BOTTLELIQUID1504
80948-007-27PUROMA Foaming Hand Alcohol Free Fragrance Free150 mL in 1 BOTTLELIQUID1504
80948-007-27PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-28PUROMA Foaming Hand Alcohol Free Fragrance Free150 mL in 1 BOTTLELIQUID1504
80948-007-28PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-29PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-29PUROMA Foaming Hand Alcohol Free Fragrance Free150 mL in 1 BOTTLELIQUID1504
80948-007-30PUROMA Foaming Hand Alcohol Free Fragrance Free2 in 1 PACKAGELIQUID24
80948-007-30PUROMA Foaming Hand Alcohol Free Fragrance Free200 mL in 1 BOTTLELIQUID2004
80948-007-31PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-31PUROMA Foaming Hand Alcohol Free Fragrance Free200 mL in 1 BOTTLELIQUID2004
80948-007-32PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-32PUROMA Foaming Hand Alcohol Free Fragrance Free200 mL in 1 BOTTLELIQUID2004
80948-007-33PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-33PUROMA Foaming Hand Alcohol Free Fragrance Free200 mL in 1 BOTTLELIQUID2004
80948-007-34PUROMA Foaming Hand Alcohol Free Fragrance Free200 mL in 1 BOTTLELIQUID2004
80948-007-34PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-35PUROMA Foaming Hand Alcohol Free Fragrance Free200 mL in 1 BOTTLELIQUID2004
80948-007-35PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-36PUROMA Foaming Hand Alcohol Free Fragrance Free220 mL in 1 BOTTLELIQUID2204
80948-007-36PUROMA Foaming Hand Alcohol Free Fragrance Free2 in 1 PACKAGELIQUID24
80948-007-37PUROMA Foaming Hand Alcohol Free Fragrance Free220 mL in 1 BOTTLELIQUID2204
80948-007-37PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-38PUROMA Foaming Hand Alcohol Free Fragrance Free220 mL in 1 BOTTLELIQUID2204
80948-007-38PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-39PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-39PUROMA Foaming Hand Alcohol Free Fragrance Free220 mL in 1 BOTTLELIQUID2204
80948-007-40PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-40PUROMA Foaming Hand Alcohol Free Fragrance Free220 mL in 1 BOTTLELIQUID2204
80948-007-41PUROMA Foaming Hand Alcohol Free Fragrance Free220 mL in 1 BOTTLELIQUID2204
80948-007-41PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-42PUROMA Foaming Hand Alcohol Free Fragrance Free2 in 1 PACKAGELIQUID24
80948-007-42PUROMA Foaming Hand Alcohol Free Fragrance Free250 mL in 1 BOTTLELIQUID2504
80948-007-43PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-43PUROMA Foaming Hand Alcohol Free Fragrance Free250 mL in 1 BOTTLELIQUID2504
80948-007-44PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-44PUROMA Foaming Hand Alcohol Free Fragrance Free250 mL in 1 BOTTLELIQUID2504
80948-007-45PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-45PUROMA Foaming Hand Alcohol Free Fragrance Free250 mL in 1 BOTTLELIQUID2504
80948-007-46PUROMA Foaming Hand Alcohol Free Fragrance Free250 mL in 1 BOTTLELIQUID2504
80948-007-46PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-47PUROMA Foaming Hand Alcohol Free Fragrance Free250 mL in 1 BOTTLELIQUID2504
80948-007-47PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-48PUROMA Foaming Hand Alcohol Free Fragrance Free2 in 1 PACKAGELIQUID24
80948-007-48PUROMA Foaming Hand Alcohol Free Fragrance Free300 mL in 1 PACKAGELIQUID3004
80948-007-49PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-49PUROMA Foaming Hand Alcohol Free Fragrance Free300 mL in 1 PACKAGELIQUID3004
80948-007-50PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-50PUROMA Foaming Hand Alcohol Free Fragrance Free300 mL in 1 PACKAGELIQUID3004
80948-007-51PUROMA Foaming Hand Alcohol Free Fragrance Free300 mL in 1 PACKAGELIQUID3004
80948-007-51PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-52PUROMA Foaming Hand Alcohol Free Fragrance Free300 mL in 1 PACKAGELIQUID3004
80948-007-52PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-53PUROMA Foaming Hand Alcohol Free Fragrance Free300 mL in 1 PACKAGELIQUID3004
80948-007-53PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-54PUROMA Foaming Hand Alcohol Free Fragrance Free350 mL in 1 BOTTLELIQUID3504
80948-007-54PUROMA Foaming Hand Alcohol Free Fragrance Free2 in 1 PACKAGELIQUID24
80948-007-55PUROMA Foaming Hand Alcohol Free Fragrance Free4 in 1 PACKAGELIQUID44
80948-007-55PUROMA Foaming Hand Alcohol Free Fragrance Free350 mL in 1 BOTTLELIQUID3504
80948-007-56PUROMA Foaming Hand Alcohol Free Fragrance Free350 mL in 1 BOTTLELIQUID3504
80948-007-56PUROMA Foaming Hand Alcohol Free Fragrance Free6 in 1 PACKAGELIQUID64
80948-007-57PUROMA Foaming Hand Alcohol Free Fragrance Free350 mL in 1 BOTTLELIQUID3504
80948-007-57PUROMA Foaming Hand Alcohol Free Fragrance Free8 in 1 PACKAGELIQUID84
80948-007-58PUROMA Foaming Hand Alcohol Free Fragrance Free12 in 1 PACKAGELIQUID124
80948-007-58PUROMA Foaming Hand Alcohol Free Fragrance Free350 mL in 1 BOTTLELIQUID3504
80948-007-59PUROMA Foaming Hand Alcohol Free Fragrance Free350 mL in 1 BOTTLELIQUID3504
80948-007-59PUROMA Foaming Hand Alcohol Free Fragrance Free24 in 1 PACKAGELIQUID244
80948-007-60PUROMA Foaming Hand Alcohol Free Fragrance Free5000 mL in 1 CANLIQUID50004
80948-007-61PUROMA Foaming Hand Alcohol Free Fragrance Free50000 mL in 1 CANLIQUID500004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-007PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE (BENZALKONIUM CHLORIDE) LIQUID [ZENITH MICRO CONTROL]4Legacy NDC, 141 package rows20231215_ed8ad2f7-8e60-4779-b5a0-2f8aeb40ed27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSNed8ad2f7-8e60-4779-b5a0-2f8aeb40ed274
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCDed8ad2f7-8e60-4779-b5a0-2f8aeb40ed274
1020365benzalkonium chloride 0.13 % Topical FoamSYed8ad2f7-8e60-4779-b5a0-2f8aeb40ed274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-007-39809480007398 BOTTLE in 1 PACKAGE (80948-007-39) > 220 mL in 1 BOTTLE8 bottle2021-03-100000-00-00NoNoCurrent