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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	af430cf4-f1b4-4b57-b8e3-87df96d655d3	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	2b089fec-cae3-4dc9-964d-d37f732a2f9f	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	6c137a93-4a34-4849-997f-bd0c572466ef	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	e8aa9709-e8f6-47a6-ab29-1fef2309786b	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	8c55b39c-8231-46a1-92ef-9fb4e3f40c1e	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	9e82dc54-aeca-457f-b4b9-2f18cc269538	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	1a8f5964-770a-4d14-a7b6-18b5da9159b0	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722cdf3-7671-eb27-e053-2a95a90a09c4	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722bf24-ae85-54f6-e053-2995a90a1d35	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721864d-0950-8379-e053-2a95a90a3bcb	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	b0e5dc67-da7a-42ac-8657-e8e4da6914be	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721ff57-0111-4bbb-e053-2995a90a1a70	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	8129e871-5f31-4138-ae47-f8978fa6287f	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	0301c1bc-db48-4635-97f5-9eaef7ab9579	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	c0c88180-ccdc-4c48-b262-3ec20d4775d4	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	ba011795-6822-4fff-b9c8-5c91cf9972a7	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	462a5f09-131f-4dfa-a502-547c44e4a4a5	2025-01-16	Warnings	Exact identifier application number: M022
Benzocaine	TOPICAL ANESTHETIC	Everpharm LLC	2bc57111-0f15-b237-e063-6294a90a4471	2025-01-15	Warnings	Exact identifier application number: M022
Kanka Triple Action	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	078fcdab-38a1-4a9a-bdd3-e17446591ea8	2025-01-09	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