Softie SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL White Tea

Product NDC
74955-054
Requested package NDC
74955-054-01
11-digit product format
749550054
Labeler code
74955
Product ID
74955-054_859444b8-b4b7-4b63-a218-8431ceace5f8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 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 packagepackage74955-05474955-054-01IInactivated 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 · 15 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…

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
74955-054-012023-01-30C16284748780-1f386c64a-120f-0266-e053-dadaa90a7c1aSoftie Soap ® SOFT & SMOOTH HAND SOAP ANTIBACTERIAL White Tea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74955-054-01Softie SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL White Tea400 mL in 1 BOTTLE, PUMPLIQUID4001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74955-054SOFTIE SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL WHITE TEA (BENZALKONIUM CHLORIDE) LIQUID [COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20210204_f9d1d6d5-ece5-4059-bfb4-e1dcec378c00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNf9d1d6d5-ece5-4059-bfb4-e1dcec378c001
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDf9d1d6d5-ece5-4059-bfb4-e1dcec378c001
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYf9d1d6d5-ece5-4059-bfb4-e1dcec378c001
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYf9d1d6d5-ece5-4059-bfb4-e1dcec378c001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74955-054-0174955005401400 mL in 1 BOTTLE, PUMP (74955-054-01) 400 ml2021-02-010000-00-00NoNoCurrent