baby wipes

Product NDC
54016-005
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 · 15 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54016-005IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-01IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-02IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-03IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-04IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-05IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-06IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-07IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-08IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-09IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-10IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-11IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-12IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-13IInactivated by FDA2026-10-05
excluded packagepackage54016-00554016-005-14IInactivated 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 5 · 270 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54016-005-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54016-005-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54016-005-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54016-005-05a1b67e2a42f9…c4cf2c586c0d…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

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
54016-005-015401600050160 PATCH in 1 PACKET (54016-005-01) > 6.85 mL in 1 PATCH60 patch2020-09-090000-00-00NoNoCurrent
54016-005-02540160005021 PATCH in 1 PACKET (54016-005-02) > 6.85 mL in 1 PATCH1 patch2020-09-090000-00-00NoNoCurrent
54016-005-035401600050310 PATCH in 1 PACKET (54016-005-03) > 6.85 mL in 1 PATCH10 patch2020-09-090000-00-00NoNoCurrent
54016-005-045401600050415 PATCH in 1 PACKET (54016-005-04) > 6.85 mL in 1 PATCH15 patch2020-09-090000-00-00NoNoCurrent
54016-005-055401600050520 PATCH in 1 PACKET (54016-005-05) > 6.85 mL in 1 PATCH20 patch2020-09-090000-00-00NoNoCurrent
54016-005-065401600050625 PATCH in 1 PACKET (54016-005-06) > 6.85 mL in 1 PATCH25 patch2020-09-090000-00-00NoNoCurrent
54016-005-075401600050730 PATCH in 1 PACKET (54016-005-07) > 6.85 mL in 1 PATCH30 patch2020-09-090000-00-00NoNoCurrent
54016-005-085401600050840 PATCH in 1 PACKET (54016-005-08) > 6.85 mL in 1 PATCH40 patch2020-09-090000-00-00NoNoCurrent
54016-005-095401600050950 PATCH in 1 PACKET (54016-005-09) > 6.85 mL in 1 PATCH50 patch2020-09-090000-00-00NoNoCurrent
54016-005-105401600051080 PATCH in 1 PACKET (54016-005-10) > 6.85 mL in 1 PATCH80 patch2020-09-090000-00-00NoNoCurrent
54016-005-115401600051190 PATCH in 1 PACKET (54016-005-11) > 6.85 mL in 1 PATCH90 patch2020-09-090000-00-00NoNoCurrent
54016-005-1254016000512100 PATCH in 1 PACKET (54016-005-12) > 6.85 mL in 1 PATCH100 patch2020-09-090000-00-00NoNoCurrent
54016-005-1354016000513120 PATCH in 1 PACKET (54016-005-13) > 6.85 mL in 1 PATCH120 patch2020-09-090000-00-00NoNoCurrent
54016-005-1454016000514150 PATCH in 1 PACKET (54016-005-14) > 6.85 mL in 1 PATCH150 patch2020-09-090000-00-00NoNoCurrent