PROCLEAN

Product NDC: 47593-602
11-digit product format: 475930602
Labeler code: 47593
Product ID: 47593-602_47afa609-ac81-43a4-bdd3-b8bf76d7e2da
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Ecolab Inc.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-10-29
Substance: BENZALKONIUM CHLORIDE
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: PROCLEAN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1731737	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
60da90e4-3467-4aea-9c44-09a9ef718995	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47593-602-11	PROCLEAN	3780 mL in 1 BOTTLE, PLASTIC	SOLUTION	3780		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47593-602	PROCLEAN (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240806_60da90e4-3467-4aea-9c44-09a9ef718995.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCLEAN	BENZALKONIUM CHLORIDE	Ecolab Inc.	60da90e4-3467-4aea-9c44-09a9ef718995	2024-08-05	Warnings	Exact identifier ndc (product): 47593-602

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731737	benzalkonium chloride 0.5 % Medicated Liquid Soap	PSN	60da90e4-3467-4aea-9c44-09a9ef718995	2
1731737	benzalkonium chloride 5 MG/ML Medicated Liquid Soap	SCD	60da90e4-3467-4aea-9c44-09a9ef718995	2
1731737	benzalkonium chloride 0.5 % Medicated Liquid Soap	SY	60da90e4-3467-4aea-9c44-09a9ef718995	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47593-602-11	47593060211	3780 mL in 1 BOTTLE, PLASTIC (47593-602-11)	3780 ml	2018-10-29	0000-00-00	No	No	Current