PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free

Product NDC
80948-004
11-digit product format
809480004
Labeler code
80948
Product ID
80948-004_bed9696c-77b3-cb78-e053-2995a90afb3a
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
2021-03-01
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 · 16 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80948-004IInactivated by FDA2026-10-05
excluded productproduct80948-004DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-01IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-02IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-03IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-04IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-05IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-06IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-07IInactivated by FDA2026-10-05
excluded packagepackage80948-00480948-004-01DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-02DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-03DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-04DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-05DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-06DDiscontinued by firm2026-10-05
excluded packagepackage80948-00480948-004-07DDiscontinued 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 3 · 168 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-03IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-04IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-07DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-06IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80948-004-07IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-05IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-03IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-04IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-07DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-06IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80948-004-07IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-03IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-04IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-07DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-06IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage80948-004-07IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-03IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-04IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage80948-004-07DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-004-01PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free10 in 1 PACKAGECLOTH102
80948-004-01PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free66 mL in 1 PACKAGECLOTH662
80948-004-02PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free20 in 1 PACKAGECLOTH202
80948-004-02PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free132 mL in 1 PACKAGECLOTH1322
80948-004-03PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free264 mL in 1 PACKAGECLOTH2642
80948-004-03PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free40 in 1 PACKAGECLOTH402
80948-004-04PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free80 in 1 PACKAGECLOTH802
80948-004-04PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free528 mL in 1 PACKAGECLOTH5282
80948-004-05PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free792 mL in 1 PACKAGECLOTH7922
80948-004-05PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free120 in 1 PACKAGECLOTH1202
80948-004-06PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free50 in 1 CANISTERCLOTH502
80948-004-06PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free350 mL in 1 PACKAGECLOTH3502
80948-004-07PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free700 mL in 1 CANISTERCLOTH7002
80948-004-07PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free100 in 1 CANISTERCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-004PUROMA ALCOHOL HAND SANITIZER WIPES FRAGRANCE FREE (ALCOHOL) CLOTH [ZENITH MICRO CONTROL]2Legacy NDC, 14 package rows20231214_bed983aa-1a5a-c97a-e053-2995a90abf7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSNbed983aa-1a5a-c97a-e053-2995a90abf7b2
1307051ethanol 0.75 ML/ML Medicated PadSCDbed983aa-1a5a-c97a-e053-2995a90abf7b2
1307051ethanol 75 % Hand Sanitizer WipesSYbed983aa-1a5a-c97a-e053-2995a90abf7b2
1307051ethyl alcohol 75 % Topical ClothSYbed983aa-1a5a-c97a-e053-2995a90abf7b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-004-018094800040110 PACKAGE in 1 PACKAGE (80948-004-01) > 66 mL in 1 PACKAGE10 package2021-03-010000-00-00NoNoCurrent
80948-004-028094800040220 PACKAGE in 1 PACKAGE (80948-004-02) > 132 mL in 1 PACKAGE20 package2021-03-010000-00-00NoNoCurrent
80948-004-038094800040340 PACKAGE in 1 PACKAGE (80948-004-03) > 264 mL in 1 PACKAGE40 package2021-03-010000-00-00NoNoCurrent
80948-004-048094800040480 PACKAGE in 1 PACKAGE (80948-004-04) > 528 mL in 1 PACKAGE80 package2021-03-010000-00-00NoNoCurrent
80948-004-0580948000405120 PACKAGE in 1 PACKAGE (80948-004-05) > 792 mL in 1 PACKAGE120 package2021-03-010000-00-00NoNoCurrent
80948-004-068094800040650 PACKAGE in 1 CANISTER (80948-004-06) > 350 mL in 1 PACKAGE50 package2021-03-010000-00-00NoNoCurrent
80948-004-0780948000407100 CANISTER in 1 CANISTER (80948-004-07) > 700 mL in 1 CANISTER100 canister2021-03-010000-00-00NoNoCurrent