Antibacterial

Product NDC
50157-508
Requested package NDC
50157-508-44
11-digit product format
501570508
Labeler code
50157
Product ID
50157-508_af4bb6ee-7847-4d11-e053-2995a90a0520
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Brands International Corporation
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-10
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 packagepackage50157-50850157-508-44IInactivated 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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-508-10AntibacterialVanilla and Shea Butter1000 mL in 1 BOTTLE, PLASTICLIQUID10002
50157-508-23AntibacterialVanilla and Shea Butter236 mL in 1 BOTTLE, PLASTICLIQUID2362
50157-508-37AntibacterialVanilla and Shea Butter3780 mL in 1 BOTTLE, PLASTICLIQUID37802
50157-508-44AntibacterialVanilla and Shea Butter443 mL in 1 BOTTLE, PLASTICLIQUID4432

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-508ANTIBACTERIAL VANILLA AND SHEA BUTTER (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]2Legacy NDC, 4 package rows20200915_aefd54bc-4707-d591-e053-2995a90a08ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNaefd54bc-4707-d591-e053-2995a90a08ed2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDaefd54bc-4707-d591-e053-2995a90a08ed2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYaefd54bc-4707-d591-e053-2995a90a08ed2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYaefd54bc-4707-d591-e053-2995a90a08ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50157-508-4450157050844443 mL in 1 BOTTLE, PLASTIC (50157-508-44) 443 ml2020-09-100000-00-00NoNoCurrent