Remedy Antimicrobial Cleanser

Product NDC: 53329-158
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-158		D	Discontinued by firm	2026-10-15
excluded package	package	53329-158	53329-158-04	D	Discontinued by firm	2026-10-15
excluded package	package	53329-158	53329-158-08	D	Discontinued by firm	2026-10-15
excluded package	package	53329-158	53329-158-34	D	Discontinued by firm	2026-10-15

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-158-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-158-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-158-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-158-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-158-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-158-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-158-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-158-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-158-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-158-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-158-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-158-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-158-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-158-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-158-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-158-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-158-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-158-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-158-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-158-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-158-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-158-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-158-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-158-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-158-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-158-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-158-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-158-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-158-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-158-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-158-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-158-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-158-34	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-158-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-158-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-158-34	`557ba5c1ecfa…`	`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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-158-08	ML - Milliliter	53329-158	fc3dfe11-1ad6-4b4e-b723-6e3115a5727d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
ACETYLCYSTEINE	INACTIVE INGREDIENT	WYQ7N0BPYC	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
MANDARIN OIL	INACTIVE INGREDIENT	NJO720F72R	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
PROLINE	INACTIVE INGREDIENT	9DLQ4CIU6V	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
TAURINE	INACTIVE INGREDIENT	1EQV5MLY3D	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
VANILLIN	INACTIVE INGREDIENT	CHI530446X	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	REMEDY ANTIMICROBIAL CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-158-04	53329015804	118 mL in 1 BOTTLE, SPRAY (53329-158-04)	118 ml	2018-03-08	0000-00-00	No	No	Current
53329-158-08	53329015808	236 mL in 1 BOTTLE, SPRAY (53329-158-08)	236 ml	2018-03-08	0000-00-00	No	No	Current
53329-158-34	53329015834	148 mL in 1 BOTTLE, PUMP (53329-158-34)	148 ml	2018-03-08	0000-00-00	No	No	Current