FDA.reportPublic FDA data

Wound Wash Antiseptic Saline with Benzalkonium Chloride

Product NDC
13709-235
Requested package NDC
13709-235-11
11-digit product format
137090235
Labeler code
13709
Product ID
13709-235_0eb06bdb-c858-98c0-e063-6394a90ab3d6
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
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 · 1 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 packagepackage13709-23513709-235-11EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
Wound Wash Antiseptic Saline with Benzalkonium Chloride
Listing expiration
2026-12-31

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13709-235-112020-04-02C16284748780-19d75b9d0-0823-f424-e053-dadaa90a57ceWound Wash Antiseptic Saline with Benzalkonium Chloride
13709-235-112020-01-31C16284748780-19d75b9d0-0823-f424-e053-dadaa90a57ceWound 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 1 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC236c62bf-3de0-0b3e-e063-6394a90ad6c62026-07-21WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC21b38b00-1e64-83d8-e063-6294a90a07bd2026-07-21WarningsExact identifier
application number: M004
DERMFREE Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a5a5603-3478-5f7a-e063-6294a90acc402026-07-21WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
application number: M004
Ever Ready First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AIDee1ad6d7-e9c1-2b20-e053-2995a90a33662026-07-03WarningsExact identifier
application number: M004
Single Antibiotic with bacitracinBACITRACIN ZINCSafetec of America4ae9a105-e3f9-4015-8844-085e0b34cdb62026-06-25WarningsExact identifier
application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact identifier
application number: M004
Medi First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation545fa5b6-781c-18ae-e063-6294a90a2f0d2026-06-16WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTIC ORIGINAL STRENGTHAldermed Inc.19eace87-b505-4be6-93b3-db5323e342162026-06-12WarningsExact identifier
application number: M004
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICAldermed Inc.7f4bff4f-588d-4e45-8aa3-f95b4d746f252026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLAldermed Inc.5bfc7776-1030-48ba-9df4-897c4984c9e62026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4545c043-8e8e-4288-b4d8-e6ec9d72f9792026-06-04WarningsExact identifier
application number: M004
First Aid Kit, Orazen Inc5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSOrazen Inc525bcb89-af5b-8652-e063-6294a90a41a62026-06-03WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.d77239e6-5e81-439a-b0cd-f8be591694422026-06-02WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BHyVee Inc3ac9f0fc-e08c-49d9-9079-3ba0393c612b2026-06-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLHyVee Inc69a4b642-b7ec-43cc-aa57-6858da0b3d632026-06-02WarningsExact identifier
application number: M004
Careland Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPlanet (Anhui) Pharmaceutical Co., Ltd.0e64179d-fce2-48fc-833e-ce43a54b987c2026-05-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Fanjian Medical Product Co.,Ltdf44ab989-c618-1831-e053-2995a90adc8e2026-05-28WarningsExact 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 ml2017-01-020000-00-00NoNoCurrent