FDA.reportPublic FDA data

PUROMA Hand Sanitizer Fragrance Free

Product NDC
80948-010
Requested package NDC
80948-010-63
11-digit product format
809480010
Labeler code
80948
Product ID
80948-010_d1783885-555d-5fee-e053-2a95a90a52b9
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
2021-03-12
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 packagepackage80948-01080948-010-63IInactivated 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#

NDC, Related label table
NDCRelated label
80948-010-0165a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-0265a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-0465a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-0565a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-0665a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-0765a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-0965a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-1065a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-1365a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-1465a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-1765a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-1865a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-1965a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-2065a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-2165a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-2265a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-2665a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-2765a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-3065a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-3365a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-3565a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-3665a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-3765a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-3865a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-4165a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-4265a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-4465a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5065a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5165a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5265a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5365a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5465a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5865a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-5965a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6065a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6265a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6365a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6565a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6665a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6765a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-6965a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-7365a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-7565a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-7665a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-7865a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-8065a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-8165a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-8265a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-8465a0ca4e-389e-4c66-a160-2ef0122ef481
80948-010-8765a0ca4e-389e-4c66-a160-2ef0122ef481

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-010-01PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-01PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-02PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-02PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-03PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-03PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-04PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-04PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-05PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-05PUROMA Hand Sanitizer Fragrance Free30 mL in 1 PACKAGELIQUID303
80948-010-06PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-06PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-07PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-07PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-08PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-08PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-09PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-09PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-10PUROMA Hand Sanitizer Fragrance Free50 mL in 1 PACKAGELIQUID503
80948-010-10PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-11PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-11PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-12PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-12PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-13PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-13PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-14PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-14PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-15PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-15PUROMA Hand Sanitizer Fragrance Free60 mL in 1 PACKAGELIQUID603
80948-010-16PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-16PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-17PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-17PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-18PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-18PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-19PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-19PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-20PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-20PUROMA Hand Sanitizer Fragrance Free100 mL in 1 PACKAGELIQUID1003
80948-010-21PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-21PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-22PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-22PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-23PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-23PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-24PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-24PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-25PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-25PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-26PUROMA Hand Sanitizer Fragrance Free200 mL in 1 PACKAGELIQUID2003
80948-010-26PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-27PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-27PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-28PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-28PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-29PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-29PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-30PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-30PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-31PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-31PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-32PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-32PUROMA Hand Sanitizer Fragrance Free250 mL in 1 PACKAGELIQUID2503
80948-010-33PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-010-33PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-34PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-34PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-35PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-35PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-36PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-36PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-37PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-37PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-38PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-38PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-39PUROMA Hand Sanitizer Fragrance Free350 mL in 1 PACKAGELIQUID3503
80948-010-39PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-40PUROMA Hand Sanitizer Fragrance Free500 mL in 1 BOTTLELIQUID5003
80948-010-40PUROMA Hand Sanitizer Fragrance Free2 in 1 PACKAGELIQUID23
80948-010-41PUROMA Hand Sanitizer Fragrance Free500 mL in 1 BOTTLELIQUID5003
80948-010-41PUROMA Hand Sanitizer Fragrance Free4 in 1 PACKAGELIQUID43
80948-010-42PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-42PUROMA Hand Sanitizer Fragrance Free500 mL in 1 BOTTLELIQUID5003
80948-010-43PUROMA Hand Sanitizer Fragrance Free5000 mL in 1 CANLIQUID50003
80948-010-44PUROMA Hand Sanitizer Fragrance Free50000 mL in 1 CANLIQUID500003
80948-010-45PUROMA Hand Sanitizer Fragrance Free200000 mL in 1 DRUMLIQUID2000003
80948-010-46PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-46PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-47PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-47PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-48PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-48PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-49PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-49PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-50PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-50PUROMA Hand Sanitizer Fragrance Free30 mL in 1 BOTTLELIQUID303
80948-010-51PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-51PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-52PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-52PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-53PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-53PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-54PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-54PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-55PUROMA Hand Sanitizer Fragrance Free50 mL in 1 BOTTLELIQUID503
80948-010-55PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-56PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-56PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-57PUROMA Hand Sanitizer Fragrance Free8 in 1 PACKAGELIQUID83
80948-010-57PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-58PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-58PUROMA Hand Sanitizer Fragrance Free12 in 1 PACKAGELIQUID123
80948-010-59PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-59PUROMA Hand Sanitizer Fragrance Free24 in 1 PACKAGELIQUID243
80948-010-60PUROMA Hand Sanitizer Fragrance Free48 in 1 PACKAGELIQUID483
80948-010-60PUROMA Hand Sanitizer Fragrance Free60 mL in 1 BOTTLELIQUID603
80948-010-61PUROMA Hand Sanitizer Fragrance Free100 mL in 1 BOTTLELIQUID1003
80948-010-61PUROMA Hand Sanitizer Fragrance Free6 in 1 PACKAGELIQUID63
80948-010-62PUROMA Hand Sanitizer Fragrance Free100 mL in 1 BOTTLELIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-010PUROMA HAND SANITIZER FRAGRANCE FREE (ALCOHOL) LIQUID [ZENITH MICRO CONTROL]3Legacy NDC, 168 package rows20231215_65a0ca4e-389e-4c66-a160-2ef0122ef481.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-010-638094800106312 BOTTLE in 1 PACKAGE (80948-010-63) > 100 mL in 1 BOTTLE12 bottle2021-10-190000-00-00NoNoCurrent