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 34 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Topco Associates LLC	be4f41bd-8a75-4fb6-8d28-67f6f853e6bd	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M003
70% Isopropyl Rubbing Alcohol	ISOPROPYL RUBBING ALCOHOL	Topco Associates LLC	9fbded5f-8dc1-4134-a711-48d1a581d874	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Topco Associates LLC	ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M003
Antibacterial Wet wipes	BENZALKONIUM CHLORIDE	Zhejiang Easyclean Daily Chemical Co., Ltd.	a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf	2026-02-11	Warnings	Exact identifier application number: M003
Universal ISOPROPYL Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0c76f14b-9a0c-4573-96f2-cd4080eb99e6	2026-02-10	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Walgreen Co.	a08ef11f-5c4f-4821-a0c0-d6c89def0bea	2026-02-10	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Walgreen Co.	fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc	2026-02-10	Warnings, Adverse reactions	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM	BENZALKONIUM CL 0.13% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	49e31509-d489-44be-e063-6394a90a97ef	2026-02-10	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM	BENZALKONIUM CL 0.13% V/V	MY IMPORTS USA LLC	4a849c4f-9b96-6b20-e063-6394a90a3486	2026-02-10	Warnings	Exact identifier application number: M003
Medline	ISOPROPYL ALCOHOL	Hy-Vee, Inc.	4bbce274-1e62-0c6a-e063-6394a90af92f	2026-02-10	Warnings	Exact identifier application number: M003
Everlit Care Products Antiseptic Wipe	ANTISEPTIC WIPE	EVERLIT GLOBAL INC.	3331e2f1-c3d0-41fc-a792-be5dcdf4e24a	2026-02-09	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS PREP PAD	ISOPROPYL ALCOHOL	EVERLIT GLOBAL INC.	77a60360-8bb5-43e9-b7e4-f71d2d488c44	2026-02-09	Warnings	Exact identifier application number: M003
Everlit Care Products Sting Relief	ISOPROPYL ALCOHOL	EVERLIT GLOBAL INC.	adfab206-b7de-4f6a-a864-edd946ea743d	2026-02-09	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS IODINE PREP PAD	POVIDONE-IODINE	EVERLIT GLOBAL INC.	5cbdb73d-333a-4244-a1c0-be430632f0ed	2026-02-09	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	6b8834be-0235-4f7c-8d52-c2f6aa2d3049	2026-02-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Salado Sales Inc.	78a46975-568a-4a88-8597-9603b8bbf935	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M003
70% Rubbing	ISOPROPYL ALCOHOL	Walgreens Co.	6ad37d18-5c19-4b5f-8313-edd430f84fb0	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walgreens Co.	1473e6e4-dc5f-43d9-a249-111a181e3f76	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Aquarrelle Antibacterial Wipes 40	BENZALKONIUM CHLORIDE	Kimberly-Clark De Mexico, S.A.B.deC.V.	3584680e-71b0-23b6-e063-6294a90a6998	2026-02-05	Warnings	Exact identifier application number: M003
Aquarrelle Antibacterial Wipes 20	BENZALKONIUM CHLORIDE	Kimberly-Clark De Mexico, S.A.B.deC.V.	35865d33-a99f-1b37-e063-6394a90a00d2	2026-02-05	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