FDA.reportPublic FDA data

nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK

Product NDC
50563-452
Requested package NDC
50563-452-01
11-digit product format
505630452
Labeler code
50563
Product ID
50563-452_c628595d-f5c6-fd2c-e053-2995a90a8ac2
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
KIT
Labeler
ENCHANTE ACCESSORIES INC.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-07-02
Marketing end
0000-00-00
Active strength
0
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 packagepackage50563-45250563-452-01IInactivated 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 · 16 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…

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
50563-452-012022-07-29C16284748780-1e4f33bdf-af11-d8a0-e053-dadaa90a6e4e50563-449/450/451/452 G1XABW14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-449-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK6 mL in 1 APPLICATORSOLUTION120 mL0.13 g in 100mL1
50563-449-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK20 in 1 PACKETSOLUTION0.13 g in 100mL1
50563-450-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK6 mL in 1 APPLICATORSOLUTION120 mL0.13 g in 100mL1
50563-450-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK20 in 1 PACKETSOLUTION0.13 g in 100mL1
50563-451-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK20 in 1 PACKETSOLUTION0.13 g in 100mL1
50563-451-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK6 mL in 1 APPLICATORSOLUTION120 mL0.13 g in 100mL1
50563-452-01nicole miller NEW YORK ANTIBACTERIAL HAND WIPES Coconut Vanilla Warm Sugar Honey Almond 3 PACK1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-452NICOLE MILLER NEW YORK ANTIBACTERIAL HAND WIPES COCONUT VANILLA WARM SUGAR HONEY ALMOND 3 PACK (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 7 package rows20210703_8fe6590e-402a-4932-a306-27589e2b3e4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN8fe6590e-402a-4932-a306-27589e2b3e4b1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD8fe6590e-402a-4932-a306-27589e2b3e4b1
1038558benzalkonium chloride 0.13 % Topical ClothSY8fe6590e-402a-4932-a306-27589e2b3e4b1
1038558benzalkonium chloride 0.13 % Topical SwabSY8fe6590e-402a-4932-a306-27589e2b3e4b1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY8fe6590e-402a-4932-a306-27589e2b3e4b1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY8fe6590e-402a-4932-a306-27589e2b3e4b1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY8fe6590e-402a-4932-a306-27589e2b3e4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50563-452-01505630452011 KIT in 1 KIT (50563-452-01) * 20 APPLICATOR in 1 PACKET (50563-451-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-450-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-449-01) > 6 mL in 1 APPLICATOR1 kit2021-07-020000-00-00NoNoCurrent