PURE X Alcohol Wipes

Product NDC
80671-002
Requested package NDC
80671-002-10
11-digit product format
806710002
Labeler code
80671
Product ID
80671-002_8d6a863f-6e56-4733-a825-62ef8d9b95ec
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
CLOTH
Route
TOPICAL
Labeler
QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-12
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 packagepackage80671-00280671-002-10IInactivated by FDA2026-10-16

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80671-002-102023-01-30C16284748780-1f386c64a-41f4-0266-e053-dadaa90a7c1aPURE X ® Alcohol Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80671-002-10PURE X Alcohol Wipes3.72 mL in 1 PACKAGECLOTH3.721
80671-002-10PURE X Alcohol Wipes100 in 1 CANISTERCLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80671-002PURE X ALCOHOL WIPES (ETHYL ALCOHOL) CLOTH [QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD]1Legacy NDC, 2 package rows20210221_f2c9bc95-a182-4b9a-a739-cba10c7e6949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSNf2c9bc95-a182-4b9a-a739-cba10c7e69491
1307051ethanol 0.75 ML/ML Medicated PadSCDf2c9bc95-a182-4b9a-a739-cba10c7e69491
1307051ethanol 75 % Hand Sanitizer WipesSYf2c9bc95-a182-4b9a-a739-cba10c7e69491
1307051ethyl alcohol 75 % Topical ClothSYf2c9bc95-a182-4b9a-a739-cba10c7e69491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80671-002-1080671000210100 PACKAGE in 1 CANISTER (80671-002-10) > 3.72 mL in 1 PACKAGE100 package2021-02-120000-00-00NoNoCurrent