FDA.reportPublic FDA data

PUROMA

Product NDC
80948-001
Requested package NDC
80948-001-05
11-digit product format
809480001
Labeler code
80948
Product ID
80948-001_d94bee8b-6633-4d80-e053-2a95a90af0a4
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-20
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 packagepackage80948-00180948-001-05DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80948-001-012025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-022025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-032025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-042025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-052025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-062025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-072025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-082025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-092025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-102025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-112025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-122025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-132025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-142025-07-29PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-012024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-022024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-032024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-042024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-052024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-062024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-072024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-082024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-092024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-102024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-112024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-122024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-132024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-142024-02-01PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-012024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-022024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-032024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-042024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-052024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-062024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-072024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-082024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-092024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-102024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-112024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-122024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-132024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes
80948-001-142024-01-30PUROMA Ethyl Alcohol 75% Antiseptic wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-001-01PUROMA66 mL in 1 PACKAGECLOTH667
80948-001-01PUROMA10 in 1 PACKAGECLOTH107
80948-001-02PUROMA20 in 1 PACKAGECLOTH207
80948-001-02PUROMA132 mL in 1 PACKAGECLOTH1327
80948-001-03PUROMA40 in 1 PACKAGECLOTH407
80948-001-03PUROMA264 mL in 1 PACKAGECLOTH2647
80948-001-04PUROMA528 mL in 1 PACKAGECLOTH5287
80948-001-04PUROMA80 in 1 PACKAGECLOTH807
80948-001-05PUROMA120 in 1 PACKAGECLOTH1207
80948-001-05PUROMA792 mL in 1 PACKAGECLOTH7927
80948-001-06PUROMA50 in 1 CANISTERCLOTH507
80948-001-06PUROMA350 mL in 1 CANISTERCLOTH3507
80948-001-07PUROMA700 mL in 1 CANISTERCLOTH7007
80948-001-07PUROMA100 in 1 CANISTERCLOTH1007
80948-001-08PUROMA10 in 1 POUCHCLOTH107
80948-001-08PUROMA66 mL in 1 POUCHCLOTH667
80948-001-09PUROMA20 in 1 POUCHCLOTH207
80948-001-09PUROMA132 mL in 1 POUCHCLOTH1327
80948-001-10PUROMA264 mL in 1 POUCHCLOTH2647
80948-001-10PUROMA40 in 1 POUCHCLOTH407
80948-001-11PUROMA80 in 1 CANISTERCLOTH807
80948-001-11PUROMA528 mL in 1 CANISTERCLOTH5287
80948-001-12PUROMA792 mL in 1 CANISTERCLOTH7927
80948-001-12PUROMA120 in 1 CANISTERCLOTH1207
80948-001-13PUROMA330 mL in 1 CANISTERCLOTH3307
80948-001-13PUROMA50 in 1 CANISTERCLOTH507
80948-001-14PUROMA660 mL in 1 CANISTERCLOTH6607
80948-001-14PUROMA100 in 1 CANISTERCLOTH1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-001PUROMA (ALCOHOL) CLOTH [ZENITH MICRO CONTROL]7Legacy NDC, 28 package rows20240202_a7e47230-7007-40e5-9214-1f6f6c77d221.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSNa7e47230-7007-40e5-9214-1f6f6c77d2217
1307051ethanol 0.75 ML/ML Medicated PadSCDa7e47230-7007-40e5-9214-1f6f6c77d2217
1307051ethanol 75 % Hand Sanitizer WipesSYa7e47230-7007-40e5-9214-1f6f6c77d2217
1307051ethyl alcohol 75 % Topical ClothSYa7e47230-7007-40e5-9214-1f6f6c77d2217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-001-0580948000105120 PACKAGE in 1 PACKAGE (80948-001-05) > 792 mL in 1 PACKAGE120 package2020-12-200000-00-00NoNoCurrent