FDA.reportPublic FDA data

Wound Wash Antiseptic Saline with Benzalkonium Chloride

Product NDC
13709-235
11-digit product format
137090235
Labeler code
13709
Product ID
13709-235_584c4b62-b410-8c89-e063-6394a90a7f57
Type
HUMAN OTC DRUG
Nonproprietary name
Wound Wash Antiseptic Saline with Benzalkonium Chloride
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
NeilMed Pharmaceuticals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-02
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 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 productproduct13709-235EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage13709-23513709-235-11EExcluded 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Wound Wash Antiseptic Saline with Benzalkonium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039012Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55a1fc63-2527-4033-e054-00144ff8d46cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-04-02Wound Wash Antiseptic Saline with Benzalkonium Chloride
2020-04-02Wound Wash Antiseptic Saline with Benzalkonium Chloride
2020-01-31Wound Wash Antiseptic Saline with Benzalkonium Chloride
2020-01-31Wound Wash Antiseptic Saline with Benzalkonium Chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-235-11Wound Wash Antiseptic Saline with Benzalkonium Chloride75 mL in 1 CANAEROSOL, SPRAY756

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-235WOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDE AEROSOL, SPRAY [NEILMED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20240112_55a1fc63-2527-4033-e054-00144ff8d46c.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 4 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lynx LX0864 peachy-foam antiseptic handsoapCHLOROXYLENOLABC Compounding Co., Inc.dd8025cb-d160-83a4-e053-2a95a90a51ac2026-05-11WarningsExact identifier
application number: M004
Satin Foam High Foaming Antiseptic Hand WashCHLOROXYLENOLCertus Medical, Inc.ea49da65-ae5e-bfde-e053-2a95a90adef22026-05-11WarningsExact identifier
application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876CHLOROXYLENOLConsolidated Chemicals, LLCf17299a4-28d6-e65b-e053-2a95a90a05e72026-05-11WarningsExact identifier
application number: M004
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
application number: M004
Harris Teeter Triple AntibioticNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINCHARRIS TEETER LLC4e81590c-32d3-f8aa-e063-6294a90ab3412026-05-06WarningsExact identifier
application number: M004
FIRSTAR TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.5b9434ad-83d7-4df3-bfef-3db152e6c6cc2026-05-04WarningsExact identifier
application number: M004
oopsie First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE4 Visions LLC50b21f0a-1e87-51ae-e063-6294a90a8a3c2026-04-30WarningsExact identifier
application number: M004
First Aid Kit, Lil Drug Store5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSLil' Drug Store Products, Inc.503c6c0e-3e1a-71ed-e063-6394a90abfa22026-04-24WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC23a35ba8-ebc6-4252-bb88-ec237425056c2026-04-15WarningsExact identifier
application number: M004
El Valle Gentian VioletGENTIAN VIOLET 1%Pharmadel LLCfc75aa2b-0e6e-e2f7-e053-6294a90ac01f2026-04-13WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSun Pharmaceutical Industries, Inc.4afdeedf-9cdf-47d6-919f-ea907fda02902026-04-10WarningsExact identifier
application number: M004
Family Care Triple Antibiotic Original Formula 0.33ozTRIPLE ANTIBIOTIC ORIGINAL FORMULAUnited Exchange Corp4f1ef127-a67e-ca60-e063-6394a90a3a3d2026-04-10WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEH E B2a143950-13b4-457e-91a4-c61a88aad84b2026-04-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4e54f479-ad87-e86b-e063-6394a90aa6d22026-03-31WarningsExact identifier
application number: M004
El Valle MerthiolateBENZALKONIUM CHLORIDEPharmadel LLCfd7b28ca-9f71-0ff6-e053-6394a90a48222026-03-26WarningsExact identifier
application number: M004
sojo Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4d8429bd-24b9-ad3c-e063-6294a90aeba02026-03-21WarningsExact identifier
application number: M004
Neosporin Plus Pain Relief ClubtrayBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf4545718-8643-a340-e053-2995a90a00792026-03-18WarningsExact identifier
application number: M004
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cd49c65-e347-7589-e063-6394a90a53bd2026-03-12WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cc6d822-f383-2ceb-e063-6294a90aecc72026-03-11WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN55a1fc63-2527-4033-e054-00144ff8d46c6
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD55a1fc63-2527-4033-e054-00144ff8d46c6
1039012benzalkonium chloride 0.13 % Topical SpraySY55a1fc63-2527-4033-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13709-235-111370902351175 mL in 1 CAN (13709-235-11) 75 ml2026-08-050000-00-00NoNoCurrent