FDA.reportPublic FDA data

FRESHMAKER ANTISEPTIC WET WIPES

Product NDC
78850-120
Requested package NDC
78850-120-00
11-digit product format
788500120
Labeler code
78850
Product ID
78850-120_a8d55210-407d-442b-b373-29c9ff4ffd1f
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
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 packagepackage78850-12078850-120-00IInactivated by FDA2026-10-15

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78850-120-002022-01-28C16284748780-1d6a99b39-5d10-a426-e053-dadaa90af4c2Freshmaker ANTISEPTIC HAND WIPES
78850-120-152022-01-28C16284748780-1d6a99b39-5d10-a426-e053-dadaa90af4c2Freshmaker ANTISEPTIC HAND WIPES
78850-120-722022-01-28C16284748780-1d6a99b39-5d10-a426-e053-dadaa90af4c2Freshmaker ANTISEPTIC HAND WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78850-120-00FRESHMAKER ANTISEPTIC WET WIPES3.6 g in 1 PACKAGECLOTH3.61
78850-120-00FRESHMAKER ANTISEPTIC WET WIPES120 in 1 PACKETCLOTH1201
78850-120-15FRESHMAKER ANTISEPTIC WET WIPES2.87 g in 1 PACKAGECLOTH2.871
78850-120-15FRESHMAKER ANTISEPTIC WET WIPES15 in 1 PACKETCLOTH151
78850-120-72FRESHMAKER ANTISEPTIC WET WIPES72 in 1 PACKETCLOTH721
78850-120-72FRESHMAKER ANTISEPTIC WET WIPES3.6 g in 1 PACKAGECLOTH3.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78850-120FRESHMAKER ANTISEPTIC WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI]1Legacy NDC, 6 package rows20200722_1cbcd01d-604e-4916-9660-82a6b5fe05e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1cbcd01d-604e-4916-9660-82a6b5fe05e51
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1cbcd01d-604e-4916-9660-82a6b5fe05e51
1038558benzalkonium chloride 0.13 % Topical ClothSY1cbcd01d-604e-4916-9660-82a6b5fe05e51
1038558benzalkonium chloride 0.13 % Topical SwabSY1cbcd01d-604e-4916-9660-82a6b5fe05e51
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1cbcd01d-604e-4916-9660-82a6b5fe05e51
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1cbcd01d-604e-4916-9660-82a6b5fe05e51
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1cbcd01d-604e-4916-9660-82a6b5fe05e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78850-120-0078850012000120 PACKAGE in 1 PACKET (78850-120-00) > 3.6 g in 1 PACKAGE120 package2020-07-010000-00-00NoNoCurrent