ProStat Blood Clotting First Aid

Product NDC: 58228-0103
11-digit product format: 582280103
Labeler code: 58228
Product ID: 58228-0103_0cde8593-950a-43ce-be26-3c6f39291cd0
Type: HUMAN OTC DRUG
Nonproprietary name: benzethonium chloride and lidocaine
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: ProStat First Aid
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-02-18
Marketing end: 0000-00-00
Substance: LIDOCAINE; BENZETHONIUM CHLORIDE
Active strength: 3400 mg/85g; mg/85g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58228-0103		I	Inactivated by FDA		2026-09-14
excluded package	package	58228-0103	58228-0103-3	I	Inactivated by FDA		2026-09-14

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 · 44 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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`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	58228-0103-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58228-0103-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58228-0103-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58228-0103-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58228-0103-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58228-0103-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58228-0103-3	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58228-0103-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58228-0103-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58228-0103-3	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	58228-0103-3	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58228-0103-3	2019-11-27	C162847	48780-1	9855e2a2-37c5-60a7-e053-dbdaa90a05bd	ProStat Blood Clotting Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58228-0103-3	ProStat Blood Clotting First Aid	85 g in 1 BOTTLE, SPRAY	AEROSOL, SPRAY	85		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
BUTANE	INACTIVE INGREDIENT	6LV4FOR43R	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
KARAYA GUM	INACTIVE INGREDIENT	73W9IQY50Q	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
PROPANE	INACTIVE INGREDIENT	T75W9911L6	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3
TRAGACANTH	INACTIVE INGREDIENT	2944357O2O	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58228-0103	PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]	3	Legacy NDC, 1 package rows	20140307_09b1372c-a5a3-4d89-9b8e-4523f6a0341f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
PH41D05744	BENZETHONIUM CHLORIDE	121-54-0	BENZETHONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1545716	benzethonium Cl 0.2 % / lidocaine 4 % Topical Spray	PSN	09b1372c-a5a3-4d89-9b8e-4523f6a0341f	3
1545716	benzethonium chloride 2 MG/ML / lidocaine 40 MG/ML Topical Spray	SCD	09b1372c-a5a3-4d89-9b8e-4523f6a0341f	3
1545716	benzethonium Cl 0.2 % / lidocaine 4 % Topical Spray	SY	09b1372c-a5a3-4d89-9b8e-4523f6a0341f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58228-0103-3	58228010303	85 g in 1 BOTTLE, SPRAY	85 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ProStat Blood Clotting Spray	ProStat First Aid \| Dixon Investments, Inc.	2014-03-07	HUMAN OTC DRUG LABEL	3