FDA.reportPublic FDA data

Wet Ones

Product NDC
63354-997
11-digit product format
633540997
Labeler code
63354
Product ID
63354-997_66621c65-b67a-05a0-e053-2991aa0a44e8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-01-29
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE
Active strength
0 1/1001
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 14 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63354-997DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-14DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-15DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-20DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-24DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-26DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-28DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-35DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-36DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-40DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-42DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-48DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-49DDiscontinued by firm2026-10-12
excluded packagepackage63354-99763354-997-65DDiscontinued by firm2026-10-12

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 4 · 222 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 packagepackage63354-997-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-65d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-49d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-36d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-997-35d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-65f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-49f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-36f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-997-35f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-652ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-492ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-362ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63354-997-352ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-49a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-36a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63354-997-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63354-997-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63354-997-65cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63354-997-49cfe11265f3b6…090c488252e2…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63354-997-142025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-152025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-202025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-242025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-262025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-282025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-352025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-362025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-402025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-422025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-482025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-492025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-652025-02-1262e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-142022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-152022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-202022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-242022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-262022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-282022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-352022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-362022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-402022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-422022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-482022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-492022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83
63354-997-652022-01-2862e53f8e-2910-0aa1-e053-2a91aa0a9b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-997-1463354099714144 SWAB in 1 PACKAGE (63354-997-14) 144 swab2018-01-290000-00-00NoNoCurrent
63354-997-206335409972020 SWAB in 1 POUCH (63354-997-20) 20 swab2018-01-290000-00-00NoNoCurrent
63354-997-246335409972424 SWAB in 1 PACKAGE (63354-997-24) 24 swab2018-01-290000-00-00NoNoCurrent
63354-997-286335409972828 SWAB in 1 POUCH (63354-997-28) 28 swab2018-01-290000-00-00NoNoCurrent
63354-997-406335409974040 SWAB in 1 CANISTER (63354-997-40) 40 swab2018-01-290000-00-00NoNoCurrent
63354-997-486335409974848 SWAB in 1 CANISTER (63354-997-48) 48 swab2018-01-290000-00-00NoNoCurrent
63354-997-496335409974948 SWAB in 1 PACKAGE (63354-997-49) 48 swab2018-01-290000-00-00NoNoCurrent
63354-997-656335409976565 SWAB in 1 CANISTER (63354-997-65) 65 swab2018-01-290000-00-00NoNoCurrent