Remedy Antimicrobial Cleanser

Product NDC
53329-158
Requested package NDC
53329-158-08
11-digit product format
533290158
Labeler code
53329
Product ID
53329-158_ebe21154-00f8-d501-e053-2a95a90ab7c8
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Medline Industries, LP
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-08-01
Marketing end
2023-12-14
Substance
BENZALKONIUM CHLORIDE
Active strength
120 mg/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage53329-15853329-158-08DDiscontinued by firm2026-10-15

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 · 12 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-158-08ML - Milliliter53329-158fc3dfe11-1ad6-4b4e-b723-6e3115a5727d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYCREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
GLYCINEINACTIVE INGREDIENTTE7660XO1CREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
MANDARIN OILINACTIVE INGREDIENTNJO720F72RREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
TAURINEINACTIVE INGREDIENT1EQV5MLY3DREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
VANILLININACTIVE INGREDIENTCHI530446XREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-158-0853329015808236 mL in 1 BOTTLE, SPRAY (53329-158-08) 236 ml2018-03-082023-12-14NoNoCurrent