FDA.reportPublic FDA data

Sterilized Wet Wipes

Product NDC
78447-001
Requested package NDC
78447-001-04
11-digit product format
784470001
Labeler code
78447
Product ID
78447-001_a78f140a-9f2c-1dc8-e053-2a95a90a27e1
Type
HUMAN OTC DRUG
Nonproprietary name
Sterilized Wet Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
ZHEJIANG BAOJIA BIOTECHNOLOGY CO., LTD.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-08
Marketing end
0000-00-00
Substance
DIDECYLDIMONIUM CHLORIDE; BENZALKONIUM CHLORIDE
Active strength
0 g/100g; 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 packagepackage78447-00178447-001-04IInactivated 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
78447-001-01Sterilized Wet Wipes
78447-001-02Sterilized Wet Wipes
78447-001-03Sterilized Wet Wipes
78447-001-04Sterilized Wet Wipes
78447-001-05Sterilized Wet Wipes
78447-001-06Sterilized Wet Wipes
78447-001-07Sterilized Wet Wipes
78447-001-08Sterilized Wet Wipes
78447-001-09Sterilized Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78447-001-01Sterilized Wet Wipes6 g in 1 BAGCLOTH61
78447-001-02Sterilized Wet Wipes30 g in 1 BAGCLOTH301
78447-001-03Sterilized Wet Wipes60 g in 1 BAGCLOTH601
78447-001-04Sterilized Wet Wipes90 g in 1 BAGCLOTH901
78447-001-05Sterilized Wet Wipes170 g in 1 BAGCLOTH1701
78447-001-06Sterilized Wet Wipes240 g in 1 BAGCLOTH2401
78447-001-07Sterilized Wet Wipes300 g in 1 BAGCLOTH3001
78447-001-08Sterilized Wet Wipes570 g in 1 BAGCLOTH5701
78447-001-09Sterilized Wet Wipes600 g in 1 BAGCLOTH6001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78447-001STERILIZED WET WIPES CLOTH [ZHEJIANG BAOJIA BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 9 package rows20200613_a78e9b84-1a98-4133-e053-2a95a90aa3fd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78447-001-047844700010490 g in 1 BAG (78447-001-04) 90 g2020-06-080000-00-00NoNoCurrent