CloSYS

Product NDC: 58578-0613
11-digit product format: 585780613
Labeler code: 58578
Product ID: 58578-0613_2db642d7-8842-4aac-9deb-6cdbd4d9f955
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrogen Peroxide
Dosage form: RINSE
Route: ORAL
Labeler: Rowpar Pharmaceuticals, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-27
Substance: HYDROGEN PEROXIDE
Active strength: 1.5 g/100mL
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: CloSYS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROGEN PEROXIDE	1.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BBX060AN9V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
358975	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
299fc7b1-af6d-4bf9-810f-d35283423fe2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58578-0613-1	CloSYS	473 mL in 1 BOTTLE	RINSE	473	2
58578-0613-5	CloSYS	473 mL in 1 BOTTLE	RINSE	473	2
58578-0613-5	CloSYS	1 in 1 CARTON	RINSE	1	2
58578-0613-7	CloSYS	473 mL in 1 BOTTLE	RINSE	473	2
58578-0613-7	CloSYS	3 in 1 PACKAGE	RINSE	3	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58578-0613	CLOSYS (HYDROGEN PEROXIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.]	1	Current NDC, 5 package rows	20250128_299fc7b1-af6d-4bf9-810f-d35283423fe2.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 2 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walgreens	fb93c7f6-e025-4cf2-9997-acfe9a0debdd	2026-08-19	Warnings	Exact identifier application number: M022
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	5965eb2a-1261-5258-e063-6294a90a7c2d	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Honey Licorice Throat Drops	MENTHOL	Prestige Brands Holdings, Inc.	5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Dual Relief	PECTIN AND MENTHOL	Prestige Brands Holdings, Inc.	d0213cb3-ec8e-40cc-82c9-694032f0490f	2026-08-19	Warnings	Exact identifier application number: M022
CVS Health Sore Throat Fast Relief Oral Anesthetic	PHENOL	CVS Pharmacy,Inc.	4fb880db-2185-41ef-a5f9-8983a28d2c5b	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Cherry	PHENOL	CVS Pharmacy,Inc.	887c68e0-ff44-4bad-b360-56fb99ed9c45	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Menthol Flavor	PHENOL	CVS PHARMACY,INC.	665be058-b965-4b78-80b0-dd8524180932	2026-08-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BBX060AN9V	HYDROGEN PEROXIDE	7722-84-1	HYDROGEN PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	299fc7b1-af6d-4bf9-810f-d35283423fe2	2
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	299fc7b1-af6d-4bf9-810f-d35283423fe2	2
358975	hydrogen peroxide 1.5 % Mouthwash	SY	299fc7b1-af6d-4bf9-810f-d35283423fe2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58578-0613-1	58578061301	473 mL in 1 BOTTLE (58578-0613-1)	473 ml	2025-01-27	No	No	Current
58578-0613-5	58578061305	1 BOTTLE in 1 CARTON (58578-0613-5) / 473 mL in 1 BOTTLE	1 bottle	2026-01-01	No	No	Current
58578-0613-7	58578061307	3 BOTTLE in 1 PACKAGE (58578-0613-7) / 473 mL in 1 BOTTLE	3 bottle	2025-11-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CloSYS Mouth Sores Oral Rinse	Rowpar Pharmaceuticals, Inc. \| Geodis Logistics LLC	2025-12-17	HUMAN OTC DRUG LABEL	2