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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52261-0500-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52261-0500-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52261-0500-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52261-0500-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52261-0500-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52261-0500-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52261-0500-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52261-0500-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52261-0500-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52261-0500-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52261-0500-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52261-0500-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52261-0500-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52261-0500-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52261-0500-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52261-0500-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52261-0500-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52261-0500-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52261-0500-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52261-0500-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52261-0500-2UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
ALLANTOIN5 g/1000mL
BENZETHONIUM CHLORIDE1 g/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1437628Internal RxNorm lookup
1487627Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08b28f52-21fc-4694-a163-91c8193b4008Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52261-0500-12025-03-28Drug Facts
52261-0500-22025-03-28Drug Facts
52261-0500-32025-03-28Drug Facts
52261-0500-12025-01-30Drug Facts
52261-0500-22025-01-30Drug Facts
52261-0500-32025-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0500-1BerbereX Wound Cleanser118 mL in 1 BOTTLE, SPRAYLIQUID1187
52261-0500-2BerbereX Wound Cleanser237 mL in 1 BOTTLE, SPRAYLIQUID2377
52261-0500-3BerbereX Wound Cleanser473 mL in 1 BOTTLE, SPRAYLIQUID4737

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0500BERBEREX WOUND CLEANSER (BENZETHONIUM CHLORIDE) LIQUID [COSCO INTERNATIONAL, INC.]6Current NDC, Legacy NDC, 3 package rows20250331_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 27 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diabetic First Aid GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELavior Pharma Inc.bda875e6-06bd-930f-e053-2995a90ab1972026-03-26WarningsExact identifier
application number: M003
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4dde3373-1c75-a815-e063-6294a90aa5572026-03-25WarningsExact identifier
application number: M003
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.48786094-aa70-d0ca-e063-6394a90acd882026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL GELDongyang Loulee Cosmetics Co.,Ltd.487c4724-b618-a071-e063-6394a90aa7822026-03-25WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLMY IMPORTS USA LLC4dbe636b-f376-7e30-e063-6394a90a722b2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLMY IMPORTS USA LLC4dbe7020-e302-8706-e063-6394a90abe7c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLMY IMPORTS USA LLC4dbe79d2-ee73-a8ed-e063-6394a90a7db52026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLMY IMPORTS USA LLC4dbe8d3f-afac-cc82-e063-6294a90ae3092026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437628allantoin 0.5 % / benzethonium chloride 0.1 % Topical SolutionPSN08b28f52-21fc-4694-a163-91c8193b40087
1487627BerbereX Wound Cleanser 0.5 % / 0.1 % Topical SolutionPSN08b28f52-21fc-4694-a163-91c8193b40087
1487627allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical Solution [Berberex Wound Cleanser]SBD08b28f52-21fc-4694-a163-91c8193b40087
1437628allantoin 5 MG/ML / benzethonium chloride 1 MG/ML Topical SolutionSCD08b28f52-21fc-4694-a163-91c8193b40087
1437628allantoin 0.5 % / benzethonium chloride 0.1 % Topical SolutionSY08b28f52-21fc-4694-a163-91c8193b40087
1487627Berberex Wound Cleanser (allantoin 0.5 % / benzethonium chloride 0.1 % ) Topical SolutionSY08b28f52-21fc-4694-a163-91c8193b40087
1487627Berberex Wound Cleanser (allantoin 5 MG/ML / benzethonium chloride 1 MG/ML) Topical SolutionSY08b28f52-21fc-4694-a163-91c8193b40087

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52261-0500-152261050001118 mL in 1 BOTTLE, SPRAY (52261-0500-1) 118 ml2015-08-240000-00-00NoNoCurrent
52261-0500-252261050002237 mL in 1 BOTTLE, SPRAY (52261-0500-2) 237 ml2015-08-240000-00-00NoNoCurrent
52261-0500-352261050003473 mL in 1 BOTTLE, SPRAY (52261-0500-3) 473 ml2015-08-240000-00-00NoNoCurrent