Sterile Antibacterial Wound Wash

Product NDC
71029-390
11-digit product format
710290390
Labeler code
71029
Product ID
71029-390_f072f265-e846-5c29-e053-2a95a90a03e8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Cosrich Group, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-09
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71029-390IInactivated by FDA2026-10-05
excluded packagepackage71029-39071029-390-04IInactivated by FDA2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct71029-390EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage71029-39071029-390-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
71029-390-042020-06-02C16284748780-19d75b9d0-d9a5-f424-e053-dadaa90a57ceDrug Facts
71029-390-042020-01-31C16284748780-19d75b9d0-d9a5-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71029-390-04Sterile Antibacterial Wound Wash120 mL in 1 CANSPRAY1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71029-390STERILE ANTIBACTERIAL WOUND WASH (BENZETHONIUM CHLORIDE) SPRAY [COSRICH GROUP, INC.]8Legacy NDC, 1 package rows20250101_d86d3988-ee4b-4396-8b5a-164c4f0394e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582205benzethonium chloride 0.13 % Topical SprayPSNd86d3988-ee4b-4396-8b5a-164c4f0394e69
582205benzethonium chloride 1.3 MG/ML Topical SpraySCDd86d3988-ee4b-4396-8b5a-164c4f0394e69
582205benzethonium chloride 0.13 % Topical SpraySYd86d3988-ee4b-4396-8b5a-164c4f0394e69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71029-390-0471029039004120 mL in 1 CAN (71029-390-04) 120 ml2017-05-090000-00-00NoNoCurrent