QUALITY CHOICE Medicated Wipes

Product NDC
63868-396
Requested package NDC
63868-396-48
11-digit product format
638680396
Labeler code
63868
Product ID
63868-396_8e37df2c-84eb-4de9-a1b5-87beb12aa05d
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
CLOTH
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-07-28
Marketing end
0000-00-00
Substance
WITCH HAZEL
Active strength
50 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage63868-39663868-396-48IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-396-482025-01-30C16284748780-12cef2736-9125-d83d-e063-dadaa90ab31fQUALITY CHOICE Medicated Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-396-48QUALITY CHOICE Medicated Wipes4.68 mL in 1 PACKAGECLOTH4.682
63868-396-48QUALITY CHOICE Medicated Wipes48 in 1 POUCHCLOTH482

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-396-48EA - Each63868-39699dd83fa-4621-4a44-a4db-7ae1ae1b8d8112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-396QUALITY CHOICE MEDICATED WIPES (WITCH HAZEL) CLOTH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Legacy NDC, 2 package rows20230122_c75c13c2-a43b-428a-9e16-8859b2cd8fe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSNc75c13c2-a43b-428a-9e16-8859b2cd8fe32
844379witch hazel 500 MG/ML Medicated PadSCDc75c13c2-a43b-428a-9e16-8859b2cd8fe32
844379witch hazel 50 % Medicated PadSYc75c13c2-a43b-428a-9e16-8859b2cd8fe32
844379witch hazel 50 % Medicated WipesSYc75c13c2-a43b-428a-9e16-8859b2cd8fe32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-396-486386803964848 PACKAGE in 1 POUCH (63868-396-48) > 4.68 mL in 1 PACKAGE48 package2021-07-280000-00-00NoNoCurrent