BerbereX Wound Cleanser

Product NDC: 58133-055
11-digit product format: 581330055
Labeler code: 58133
Product ID: 58133-055_1d8d9dbb-4554-49ea-98ea-d63e508f34fd
Type: HUMAN OTC DRUG
Nonproprietary name: Allantoin, Benzethonium Chloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Cosmetic Specialty Labs, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-09-15
Marketing end: 0000-00-00
Substance: ALLANTOIN; BENZETHONIUM CHLORIDE
Active strength: 5 g/1000mL; g/1000mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58133-055		I	Inactivated by FDA	2026-10-12
excluded package	package	58133-055	58133-055-04	I	Inactivated by FDA	2026-10-12
excluded package	package	58133-055	58133-055-08	I	Inactivated by FDA	2026-10-12
excluded package	package	58133-055	58133-055-16	I	Inactivated by FDA	2026-10-12

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 2 · 84 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	58133-055-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58133-055-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58133-055-08	`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	58133-055-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58133-055-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58133-055-08	`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	58133-055-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58133-055-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58133-055-08	`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	58133-055-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58133-055-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58133-055-08	`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	58133-055-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58133-055-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58133-055-08	`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	58133-055-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58133-055-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58133-055-08	`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	58133-055-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58133-055-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58133-055-08	`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	58133-055-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58133-055-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58133-055-08	`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	58133-055-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58133-055-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58133-055-08	`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	58133-055-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58133-055-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58133-055-08	`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	58133-055-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58133-055-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58133-055-08	`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	58133-055-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58133-055-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58133-055-08	`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	58133-055-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58133-055-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58133-055-08	`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	58133-055-16	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58133-055-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58133-055-08	`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	58133-055-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58133-055-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58133-055-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-055-04	2020-01-31	C162847	48780-1	9d75b9d0-a22b-f424-e053-dadaa90a57ce	cd8c1230-f356-4587-8e49-4c7db6e09849
58133-055-08	2020-01-31	C162847	48780-1	9d75b9d0-a22b-f424-e053-dadaa90a57ce	cd8c1230-f356-4587-8e49-4c7db6e09849
58133-055-16	2020-01-31	C162847	48780-1	9d75b9d0-a22b-f424-e053-dadaa90a57ce	cd8c1230-f356-4587-8e49-4c7db6e09849

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58133-055-04	BerbereX Wound Cleanser	118 mL in 1 BOTTLE	SOLUTION	118	3
58133-055-08	BerbereX Wound Cleanser	236 mL in 1 BOTTLE	SOLUTION	236	3
58133-055-16	BerbereX Wound Cleanser	473 mL in 1 BOTTLE	SOLUTION	473	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
ALOE VERA WHOLE	INACTIVE INGREDIENT	KIZ4X2EHYX	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
HYDRASTIS CANADENSIS WHOLE	INACTIVE INGREDIENT	R763EBH88T	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
Hydrogen Peroxide	INACTIVE INGREDIENT	BBX060AN9V	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3
PANAX QUINQUEFOLIUS WHOLE	INACTIVE INGREDIENT	0P067WOA1X	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-055	BERBEREX WOUND CLEANSER (ALLANTOIN, BENZETHONIUM CHLORIDE) SOLUTION [COSMETIC SPECIALTY LABS, INC.]	3	Legacy NDC, 3 package rows	20140131_cd8c1230-f356-4587-8e49-4c7db6e09849.zip

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	cd8c1230-f356-4587-8e49-4c7db6e09849	3
1487627	BerbereX Wound Cleanser 0.5 % / 0.1 % Topical Solution	PSN	cd8c1230-f356-4587-8e49-4c7db6e09849	3
1487627	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]	SBD	cd8c1230-f356-4587-8e49-4c7db6e09849	3
1437628	allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution	SCD	cd8c1230-f356-4587-8e49-4c7db6e09849	3
1437628	allantoin 0.5 % / benzethonium chloride 0.1 % Topical Solution	SY	cd8c1230-f356-4587-8e49-4c7db6e09849	3
1487627	Berberex Wound Cleanser (allantoin 0.5 % / benzethonium chloride 0.1 % ) Topical Solution	SY	cd8c1230-f356-4587-8e49-4c7db6e09849	3
1487627	Berberex Wound Cleanser (allantoin 5 MG/ML / benzethonium chloride 1 MG/ML) Topical Solution	SY	cd8c1230-f356-4587-8e49-4c7db6e09849	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58133-055-04	58133005504	118 mL in 1 BOTTLE	118 ml	Historical
58133-055-08	58133005508	236 mL in 1 BOTTLE	236 ml	Historical
58133-055-16	58133005516	473 mL in 1 BOTTLE	473 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BerbereX Wound Cleanser - Cosmetic Specialty Labs, Inc.	Cosmetic Specialty Labs, Inc.	2014-01-23	HUMAN OTC DRUG LABEL	3