FDA.reportPublic FDA data

ABUTOL ANTISEPTIC WET WIPES

Product NDC
78850-102
Requested package NDC
78850-102-01
11-digit product format
788500102
Labeler code
78850
Product ID
78850-102_c78979f4-0ed3-4c68-9b58-ea2b56b4f679
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
2020-09-01
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 packagepackage78850-10278850-102-01IInactivated by FDA2026-10-12

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 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
78850-102-012022-01-28C16284748780-1d6a99b39-5ffa-a426-e053-dadaa90af4c2ABUTOL English Lavender ANTISEPTIC WET WIPES
78850-102-022022-01-28C16284748780-1d6a99b39-5ffa-a426-e053-dadaa90af4c2ABUTOL English Lavender ANTISEPTIC WET WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78850-102-01ABUTOL ANTISEPTIC WET WIPESENGLISH LAVANDER2.87 g in 1 PACKAGECLOTH2.871
78850-102-01ABUTOL ANTISEPTIC WET WIPESENGLISH LAVANDER20 in 1 PACKETCLOTH201
78850-102-02ABUTOL ANTISEPTIC WET WIPESENGLISH LAVANDER3.6 g in 1 PACKAGECLOTH3.61
78850-102-02ABUTOL ANTISEPTIC WET WIPESENGLISH LAVANDER120 in 1 PACKETCLOTH1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78850-102ABUTOL ANTISEPTIC WET WIPES ENGLISH LAVANDER (BENZALKONIUM CHLORIDE) CLOTH [FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI]1Legacy NDC, 4 package rows20200903_b58b4548-80b3-4167-b8fa-083dfeca7191.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNb58b4548-80b3-4167-b8fa-083dfeca71911
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDb58b4548-80b3-4167-b8fa-083dfeca71911
1038558benzalkonium chloride 0.13 % Topical ClothSYb58b4548-80b3-4167-b8fa-083dfeca71911
1038558benzalkonium chloride 0.13 % Topical SwabSYb58b4548-80b3-4167-b8fa-083dfeca71911
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYb58b4548-80b3-4167-b8fa-083dfeca71911
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYb58b4548-80b3-4167-b8fa-083dfeca71911
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYb58b4548-80b3-4167-b8fa-083dfeca71911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78850-102-017885001020120 PACKAGE in 1 PACKET (78850-102-01) > 2.87 g in 1 PACKAGE20 package2020-09-010000-00-00NoNoCurrent