PRO-SYS

Product NDC: 70275-201
11-digit product format: 702750201
Labeler code: 70275
Product ID: 70275-201_57dbfe25-5b60-3ad1-e063-6294a90a0a76
Type: HUMAN OTC DRUG
Nonproprietary name: Oral Wound Cleanser
Dosage form: LIQUID
Route: DENTAL
Labeler: Forward Science Technologies LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-16
Substance: HYDROGEN PEROXIDE
Active strength: 15 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 21 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70275-201-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70275-201-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70275-201-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70275-201-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70275-201-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70275-201-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70275-201-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70275-201-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70275-201-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70275-201-28	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70275-201-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70275-201-28	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70275-201-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70275-201-28	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: PRO-SYS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROGEN PEROXIDE	15 mg/mL

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
205336	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
c357c8f8-6fd6-c2f8-e053-2995a90a4023	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70275-201-16	2025-03-25	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-16	2025-03-25	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-16	2025-03-25	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-28	2025-03-25	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-28	2025-03-25	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-28	2025-03-25	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-16	2025-01-30	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-16	2025-01-30	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-16	2025-01-30	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-28	2025-01-30	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-28	2025-01-30	c357c8f8-6fd6-c2f8-e053-2995a90a4023
70275-201-28	2025-01-30	c357c8f8-6fd6-c2f8-e053-2995a90a4023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70275-201-16	PRO-SYS	473 mL in 1 BOTTLE	LIQUID	473		6
70275-201-28	PRO-SYS	3785 mL in 1 BOTTLE	LIQUID	3785		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70275-201	OXISTOM (ORAL WOUND CLEANSER) LIQUID PRO-SYS (ORAL WOUND CLEANSER) LIQUID [FORWARD SCIENCE TECHNOLOGIES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250327_c357c8f8-6fd6-c2f8-e053-2995a90a4023.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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Meijer, Inc.	c9c17224-9304-403a-b6a1-9c8bd94e3d94	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M022
AQUAFRESH CAVITY PROTECTION	SODIUM FLUORIDE	Haleon US Holdings LLC	5484999c-8e6f-430d-99a5-6893a2489467	2026-02-16	Warnings	Exact identifier application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTION	SODIUM FLUORIDE	Haleon US Holdings LLC	aaff19d9-4ba5-462a-893b-7220feb25d6c	2026-02-16	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Walgreen Co.	55807b18-42ed-45a7-845e-fcf7f5d70d04	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: m022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Walgreen Co.	33223589-4ff4-4e4e-96da-6fa2e4d0f187	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M022
PERIOSCIENCES SENSITIVE AO Pro	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	PERIOSCIENCES LLC	acca8964-b575-468c-8b40-514dfbf50778	2026-02-09	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Retail Business Services, LLC	d46546d0-c6df-431a-8ab0-bc5013c084d7	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	e19228e9-6f87-456e-a222-f979a234d589	2026-02-06	Warnings	Exact identifier application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	49d28991-b68f-ba16-e063-6394a90a0b13	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Strawberry Lemonade	PECTIN	Primrose Candy Co.	49e2b303-1018-cd13-e063-6394a90ae300	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Berry Lemonade	PECTIN	Primrose Candy Co.	49cee56f-c45f-6c79-e063-6294a90a5f8f	2026-02-01	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Rite Aid Corporation	294418aa-640d-42be-ad07-de31da7a7ccc	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	aa61ce6f-8336-4071-93b8-549fd22d1ae0	2026-01-22	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	866067b9-3dce-492d-ae99-1b807ecd56ff	2026-01-22	Warnings	Exact identifier application number: M022
Family Wellness Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR (Family Wellness)	92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea	2026-01-21	Warnings	Exact identifier application number: M022
Crest Pro-Health All Day Clean Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	48eaca4c-19c2-2dd2-e063-6394a90a3e08	2026-01-21	Warnings	Exact identifier application number: M022
Betadine Gargle	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	5f0a3377-1398-2603-c632-f0d214bb88ec	2026-01-21	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Universal Distribution Center LLC	e276ba37-46fb-4ed9-9ee1-c08a2a89704a	2026-01-20	Warnings	Exact identifier application number: M022
Equate Orasol	20% BENZOCAINE	WAL-MART STORES INC.	08404780-8252-4484-b1c3-8970803f74f8	2026-01-19	Warnings	Exact identifier application number: M022
Equate Healthy Mouth	CPC 0.05% ANTIPLAQUE/ANTI-GINGIVITIS	Walmart, Inc.	1cc1f6fd-67d4-b314-e063-6294a90ab995	2026-01-19	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
205336	hydrogen peroxide 1.5 % Mucous Membrane Topical Solution	PSN	c357c8f8-6fd6-c2f8-e053-2995a90a4023	6
205336	hydrogen peroxide 15 MG/ML Mucous Membrane Topical Solution	SCD	c357c8f8-6fd6-c2f8-e053-2995a90a4023	6
205336	hydrogen peroxide 1.5 % Mucous Membrane Topical Solution	SY	c357c8f8-6fd6-c2f8-e053-2995a90a4023	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70275-201-16	70275020116	473 mL in 1 BOTTLE (70275-201-16)	473 ml	2022-05-16	0000-00-00	No	No	Current
70275-201-28	70275020128	3785 mL in 1 BOTTLE (70275-201-28)	3785 ml	2022-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OxiStom - Forward Science Technologies LLC	Forward Science Technologies LLC	2026-07-30	HUMAN OTC DRUG LABEL	7