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 51 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceced03-eeb8-fced-e053-2995a90afd5c	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dced643b-96fb-193f-e053-2a95a90a16aa	2025-12-06	Warnings	Exact identifier application number: M003
Betadine Foam Cleanser	BENZALKONIUM CHLORIDE	Atlantis Consumer Healthcare, Inc.	3be9fa6e-3ae8-496b-876b-f81f1cd98af4	2025-12-05	Warnings	Exact identifier application number: M003
2XL Mega Rolls Sanitizing Wipes	BENZALKONIUM CHLORIDE	2xl Corporation	9da541ab-6836-4149-a86d-3b2f2e586628	2025-12-05	Warnings	Exact identifier application number: M003
Hand Wipes	BENZALKONIUM CHLORIDE	Advanced Ultrasound Solutions Inc.	2c2abaa8-c152-470b-a4d9-5056815a1987	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	SANITIZING HAND WIPES	ALO NEW YORK LLC	d3d95355-3af7-43e3-e053-2a95a90a0fa4	2025-12-05	Warnings	Exact identifier application number: M003
Giant Eagle Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	Giant Eagle	e20e9a93-03c3-77f8-e053-2995a90ae59f	2025-12-05	Warnings	Exact identifier application number: M003
Antibacterial Wipes	BENZALKONIUM CHLORIDE	ERC Acquisition, Inc	dc6c39af-447c-481a-98b5-33b8f09b83bc	2025-12-05	Warnings	Exact identifier application number: M003
Sanitex Antibacterial Hand Wipes Fresh Scent	BENZALKONIUM CHLORIDE	Precare Corp	48907146-ca66-46e1-928b-a8f968a6bff8	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	ANTIBACTERIAL HAND WIPES	Quest USA Corp	d9ab219d-07e3-2019-e053-2a95a90a1668	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	DUAL ACTION ANTIBACTERIAL WIPES	Avro Enterprises LLC	cf42e470-19c8-2e11-e053-2995a90ae90d	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	DUAL ACTION ANTIMICROBIAL WIPES	Avro Enterprises LLC	cf4680f4-24b2-1242-e053-2a95a90a9374	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	ANTIBACTERIAL HAND WIPES	Target Corporation	f6037707-c6bb-11a0-e053-2995a90acce8	2025-12-05	Warnings	Exact identifier application number: M003
Sanitizing Wipes	BENZALKONIUM CHLORIDE	Zogics, LLC	2cd916ee-dc6d-49e4-a9b5-06ad4b2b054d	2025-12-05	Warnings	Exact identifier application number: M003
GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGE	BENZALKONIUM CHLORIDE	CHEMCO CORPORATION	f28c2c1e-7d0a-45b9-e053-2995a90a4710	2025-12-05	Warnings	Exact identifier application number: M003
GELLE-N-DETOX ICE MINT AND EUCALYPTUS MASSAGE	BENZALKONIUM CHLORIDE	CHEMCO CORPORATION	f2a107aa-5ad3-7bad-e053-2a95a90a1d97	2025-12-05	Warnings	Exact identifier application number: M003
PROHEAL POVIDONE IODINE SWABSTICK	POVIDONE-IODINE	Click Industries LLC	974e1205-01ab-4599-9229-cdf5225d268a	2025-12-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Jasmine Gardenia	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	45082749-6f53-c595-e063-6294a90ac3e9	2025-12-03	Warnings	Exact identifier application number: M003
ALCOHOL PREP PAD	70% ISOPROPY ALCOHOL SWAB	PurCel Labs LLC	450c39fd-d172-492e-e063-6294a90aa396	2025-12-03	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Dynarex Corporation	450e56f0-b8ae-072a-e063-6394a90a2d4b	2025-12-03	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