BerbereX Wound Cleanser

Product NDC: 52261-0500
11-digit product format: 522610500
Labeler code: 52261
Product ID: 52261-0500_d3e2c5a1-5f63-4c96-8fbe-1ba6c8c5d93d
Type: HUMAN OTC DRUG
Nonproprietary name: Benzethonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Cosco International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-17
Substance: ALLANTOIN; BENZETHONIUM CHLORIDE
Active strength: 5; 1 g/1000mL; g/1000mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 28 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	52261-0500-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52261-0500-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52261-0500-1	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	52261-0500-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52261-0500-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52261-0500-1	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	52261-0500-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52261-0500-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52261-0500-1	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	52261-0500-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52261-0500-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52261-0500-1	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	52261-0500-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52261-0500-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52261-0500-2	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	52261-0500-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52261-0500-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52261-0500-2	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	52261-0500-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52261-0500-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52261-0500-2	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: BerbereX Wound Cleanser
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLANTOIN	5 g/1000mL
BENZETHONIUM CHLORIDE	1 g/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
344S277G0Z	Internal UNII lookup
PH41D05744	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1437628	Internal RxNorm lookup
1487627	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
08b28f52-21fc-4694-a163-91c8193b4008	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
52261-0500-1	2025-03-28	Drug Facts
52261-0500-2	2025-03-28	Drug Facts
52261-0500-3	2025-03-28	Drug Facts
52261-0500-1	2025-01-30	Drug Facts
52261-0500-2	2025-01-30	Drug Facts
52261-0500-3	2025-01-30	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52261-0500-1	BerbereX Wound Cleanser	118 mL in 1 BOTTLE, SPRAY	LIQUID	118	7
52261-0500-2	BerbereX Wound Cleanser	237 mL in 1 BOTTLE, SPRAY	LIQUID	237	7
52261-0500-3	BerbereX Wound Cleanser	473 mL in 1 BOTTLE, SPRAY	LIQUID	473	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
ALOE VERA WHOLE	INACTIVE INGREDIENT	KIZ4X2EHYX	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
HYDRASTIS CANADENSIS WHOLE	INACTIVE INGREDIENT	R763EBH88T	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
hydrogen peroxide	INACTIVE INGREDIENT	BBX060AN9V	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
PANAX QUINQUEFOLIUS WHOLE	INACTIVE INGREDIENT	0P067WOA1X	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52261-0500	BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]	6	Current NDC, Legacy NDC, 3 package rows	20250331_08b28f52-21fc-4694-a163-91c8193b4008.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 83 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XTRA	BENZALKONIUM CHLORIDE	MY IMPORTS USA LLC	27f4ff15-5480-8842-e063-6294a90ad35b	2025-03-06	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f982aef-4f46-aa85-e063-6394a90a52b1	2025-03-05	Warnings	Exact identifier application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f9846ce-37ca-a95b-e063-6294a90ad260	2025-03-05	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f988951-39e7-ec02-e063-6294a90aaad7	2025-03-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	2f98a900-6c7c-0161-e063-6294a90ac675	2025-03-05	Warnings	Exact identifier application number: M003
3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Universal Distribution Center LLC	2f98ba8c-0ab1-e256-e063-6394a90abe8f	2025-03-05	Warnings	Exact identifier application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2f800ea4-b8bb-0cb4-e063-6294a90a7e23	2025-03-04	Warnings	Exact identifier application number: M003
Thera Plus Pain Relief Cleansing	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	513a620e-f69a-488d-8abc-36e2efccdc13	2025-03-04	Warnings	Exact identifier application number: M003
Clorox Hand Sanitizer	ALCOHOL	Brand Buzz LLC	bdd47d2f-5332-1430-e053-2a95a90a1c33	2025-03-03	Warnings	Exact identifier application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2f7c4066-3baa-25f2-e063-6394a90a00eb	2025-03-03	Warnings	Exact identifier application number: M003
Procure Products Hand Sanitizing Wipes	ALCOHOL 70% ANTIBACTERIAL WIPES	TWIN MED LLC	1f378bee-88f7-14cf-e063-6394a90a4888	2025-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	INSTANT HAND SANITIZER	Raining Rose, Inc	2f37a2a1-5250-4052-e063-6294a90aef7f	2025-02-28	Warnings	Exact identifier application number: M003
Signature Care Advanced Hand Sanitizer with Aloe	ALCOHOL	Yiwu Yangjie Daily Chemicals Co.,Ltd.	a20c821a-80d9-499c-aecd-3cf4d8e02590	2025-02-27	Warnings	Exact identifier application number: M003
Signature Care Advanced Hand Sanitizer	ALCOHOL	Yiwu Yangjie Daily Chemicals Co.,Ltd.	d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e	2025-02-27	Warnings	Exact identifier application number: M003
Signature Care Advanced Hand Sanitizer with Aloe	ALCOHOL	Yiwu Yangjie Daily Chemicals Co.,Ltd.	f2309f34-a1ee-44c7-b818-7384de64d27b	2025-02-27	Warnings	Exact identifier application number: M003
Signature Care Advanced Hand Sanitizer	ALCOHOL	Yiwu Yangjie Daily Chemicals Co.,Ltd.	dcfc08a0-ecd6-42d3-9ff2-e68d5317152f	2025-02-27	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	AmerisourceBergen (Good Neighbor Pharmacy) 46122	c47986e9-c851-491b-817e-fd3e0b054cd4	2025-02-26	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	AmerisourceBergen (Good Neighbor Pharmacy) 46122	00737139-bab8-40be-ad85-32526b5eab10	2025-02-26	Warnings	Exact identifier application number: M003
AUM Alcohol Pad	ALCOHOL PAD	SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS	632da1b7-70bb-467d-81b2-39536f9fff3c	2025-02-26	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Universal Synergetics, Inc	0dd6884c-935f-4523-b19a-201b7a8666fc	2025-02-24	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN
PH41D05744	BENZETHONIUM CHLORIDE	121-54-0	BENZETHONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1437628	allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution	PSN	08b28f52-21fc-4694-a163-91c8193b4008	7
1487627	BerbereX Wound Cleanser 0.5 % / 0.1 % Topical Solution	PSN	08b28f52-21fc-4694-a163-91c8193b4008	7
1487627	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]	SBD	08b28f52-21fc-4694-a163-91c8193b4008	7
1437628	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution	SCD	08b28f52-21fc-4694-a163-91c8193b4008	7
1437628	allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution	SY	08b28f52-21fc-4694-a163-91c8193b4008	7
1487627	Berberex Wound Cleanser (allantoin 0.5 % / benzethonium chloride 0.1 % ) Topical Solution	SY	08b28f52-21fc-4694-a163-91c8193b4008	7
1487627	Berberex Wound Cleanser (allantoin 5 MG/ML / benzethonium chloride 1 MG/ML) Topical Solution	SY	08b28f52-21fc-4694-a163-91c8193b4008	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52261-0500-1	52261050001	118 mL in 1 BOTTLE, SPRAY (52261-0500-1)	118 ml	2015-08-24	0000-00-00	No	No	Current
52261-0500-2	52261050002	237 mL in 1 BOTTLE, SPRAY (52261-0500-2)	237 ml	2015-08-24	0000-00-00	No	No	Current
52261-0500-3	52261050003	473 mL in 1 BOTTLE, SPRAY (52261-0500-3)	473 ml	2015-08-24	0000-00-00	No	No	Current