Saloon Antibacterial Hand Wash Ocean

Product NDC
81608-003
Requested package NDC
81608-003-00
11-digit product format
816080003
Labeler code
81608
Product ID
81608-003_c07ee239-7c47-ce5c-e053-2995a90a3dc3
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 packagepackage81608-00381608-003-00IInactivated 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
81608-003-002024-01-30C16284748780-11030e365-1941-111a-e063-dadaa90a10e2Saloon Antibacterial Hand Wash Ocean

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81608-003-00Saloon Antibacterial Hand Wash Ocean400 mL in 1 BOTTLE, PUMPSOLUTION4002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81608-003SALOON ANTIBACTERIAL HAND WASH OCEAN (BENZALKONIUM CHLORIDE) SOLUTION [TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI]2Legacy NDC, 1 package rows20210422_bcb5af7d-2afd-7b55-e053-2995a90a9d0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNbcb5af7d-2afd-7b55-e053-2995a90a9d0e2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDbcb5af7d-2afd-7b55-e053-2995a90a9d0e2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYbcb5af7d-2afd-7b55-e053-2995a90a9d0e2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYbcb5af7d-2afd-7b55-e053-2995a90a9d0e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81608-003-0081608000300400 mL in 1 BOTTLE, PUMP (81608-003-00) 400 ml2021-04-010000-00-00NoNoCurrent