Sanitizing Wipes

Product NDC
80991-001
Requested package NDC
80991-001-02
11-digit product format
809910001
Labeler code
80991
Product ID
80991-001_b3404d03-29c8-a5ca-e053-2a95a90a6072
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
Zhejiang Fanjia Medical Equipment Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-03
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage80991-00180991-001-02IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
80991-001-012022-01-28C16284748780-1d6a99b39-cba7-a426-e053-dadaa90af4c275 ALCOHOL fanjia
80991-001-022022-01-28C16284748780-1d6a99b39-cba7-a426-e053-dadaa90af4c275 ALCOHOL fanjia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80991-001-01Sanitizing Wipes1.5 g in 1 APPLICATORCLOTH1.53
80991-001-01Sanitizing Wipes160 in 1 POUCHCLOTH1603
80991-001-02Sanitizing Wipes160 in 1 CANISTERCLOTH1603
80991-001-02Sanitizing Wipes5 g in 1 APPLICATORCLOTH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80991-001SANITIZING WIPES (ALCOHOL) CLOTH [ZHEJIANG FANJIA MEDICAL EQUIPMENT CO., LTD.]3Legacy NDC, 4 package rows20201105_b32a46b5-26b4-a3b2-e053-2995a90af325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSNb32a46b5-26b4-a3b2-e053-2995a90af3253
1307051ethanol 0.75 ML/ML Medicated PadSCDb32a46b5-26b4-a3b2-e053-2995a90af3253
1307051ethanol 75 % Hand Sanitizer WipesSYb32a46b5-26b4-a3b2-e053-2995a90af3253
1307051ethyl alcohol 75 % Topical ClothSYb32a46b5-26b4-a3b2-e053-2995a90af3253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80991-001-0280991000102160 APPLICATOR in 1 CANISTER (80991-001-02) > 5 g in 1 APPLICATOR160 applicator2020-11-030000-00-00NoNoCurrent