FDA.reportPublic FDA data

baby wipes

Product NDC
54016-005
Requested package NDC
54016-005-04
11-digit product format
540160005
Labeler code
54016
Product ID
54016-005_b01b2e02-d065-7413-e053-2995a90a0913
Type
HUMAN OTC DRUG
Nonproprietary name
baby wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jinhua Huihuang Non-woven Products Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-09
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
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 packagepackage54016-00554016-005-04IInactivated 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
54016-005-01baby wipes 60pcs NDC: 54016-005-01
54016-005-02baby wipes 60pcs NDC: 54016-005-01
54016-005-03baby wipes 60pcs NDC: 54016-005-01
54016-005-04baby wipes 60pcs NDC: 54016-005-01
54016-005-05baby wipes 60pcs NDC: 54016-005-01
54016-005-06baby wipes 60pcs NDC: 54016-005-01
54016-005-07baby wipes 60pcs NDC: 54016-005-01
54016-005-08baby wipes 60pcs NDC: 54016-005-01
54016-005-09baby wipes 60pcs NDC: 54016-005-01
54016-005-10baby wipes 60pcs NDC: 54016-005-01
54016-005-11baby wipes 60pcs NDC: 54016-005-01
54016-005-12baby wipes 60pcs NDC: 54016-005-01
54016-005-13baby wipes 60pcs NDC: 54016-005-01
54016-005-14baby wipes 60pcs NDC: 54016-005-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54016-005-01baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-01baby wipes60 in 1 PACKETCLOTH602
54016-005-02baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-02baby wipes1 in 1 PACKETCLOTH12
54016-005-03baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-03baby wipes10 in 1 PACKETCLOTH102
54016-005-04baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-04baby wipes15 in 1 PACKETCLOTH152
54016-005-05baby wipes20 in 1 PACKETCLOTH202
54016-005-05baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-06baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-06baby wipes25 in 1 PACKETCLOTH252
54016-005-07baby wipes30 in 1 PACKETCLOTH302
54016-005-07baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-08baby wipes40 in 1 PACKETCLOTH402
54016-005-08baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-09baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-09baby wipes50 in 1 PACKETCLOTH502
54016-005-10baby wipes80 in 1 PACKETCLOTH802
54016-005-10baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-11baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-11baby wipes90 in 1 PACKETCLOTH902
54016-005-12baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-12baby wipes100 in 1 PACKETCLOTH1002
54016-005-13baby wipes120 in 1 PACKETCLOTH1202
54016-005-13baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-14baby wipes6.85 mL in 1 PATCHCLOTH6.852
54016-005-14baby wipes150 in 1 PACKETCLOTH1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54016-005BABY WIPES CLOTH [JINHUA HUIHUANG NON-WOVEN PRODUCTS CO., LTD.]2Legacy NDC, 28 package rows20200925_aef07b16-36f6-19de-e053-2a95a90a5c70.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54016-005-045401600050415 PATCH in 1 PACKET (54016-005-04) > 6.85 mL in 1 PATCH15 patch2020-09-090000-00-00NoNoCurrent