FDA.reportPublic FDA data

SANITARY WET WIPES

Product NDC
81306-001
Requested package NDC
81306-001-06
11-digit product format
813060001
Labeler code
81306
Product ID
81306-001_b77d5463-f079-b694-e053-2a95a90a0dbb
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitary Wet Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
Dandong Xinshidai Biotec Pharmaceuticals Co.,LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-06
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 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 packagepackage81306-00181306-001-06IInactivated 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, Related label table
NDCRelated label
81306-001-01SANITARY WET WIPES
81306-001-02SANITARY WET WIPES
81306-001-03SANITARY WET WIPES
81306-001-04SANITARY WET WIPES
81306-001-05SANITARY WET WIPES
81306-001-06SANITARY WET WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81306-001-01SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-01SANITARY WET WIPES1 in 1 BAGCLOTH12
81306-001-02SANITARY WET WIPES10 in 1 BAGCLOTH102
81306-001-02SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-03SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-03SANITARY WET WIPES60 in 1 BAGCLOTH602
81306-001-04SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-04SANITARY WET WIPES72 in 1 BAGCLOTH722
81306-001-05SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-05SANITARY WET WIPES80 in 1 BAGCLOTH802
81306-001-06SANITARY WET WIPES100 in 1 BAGCLOTH1002
81306-001-06SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81306-001SANITARY WET WIPES CLOTH [DANDONG XINSHIDAI BIOTEC PHARMACEUTICALS CO.,LTD]2Legacy NDC, 12 package rows20201228_b716cb7d-d46c-caaa-e053-2a95a90aac7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNb716cb7d-d46c-caaa-e053-2a95a90aac7c2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDb716cb7d-d46c-caaa-e053-2a95a90aac7c2
1038558benzalkonium chloride 0.13 % Topical ClothSYb716cb7d-d46c-caaa-e053-2a95a90aac7c2
1038558benzalkonium chloride 0.13 % Topical SwabSYb716cb7d-d46c-caaa-e053-2a95a90aac7c2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYb716cb7d-d46c-caaa-e053-2a95a90aac7c2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYb716cb7d-d46c-caaa-e053-2a95a90aac7c2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYb716cb7d-d46c-caaa-e053-2a95a90aac7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81306-001-0681306000106100 PATCH in 1 BAG (81306-001-06) > 5.5 g in 1 PATCH100 patch2020-11-060000-00-00NoNoCurrent