FDA.reportPublic FDA data

Eyewash Station Additive Concentrate

Product NDC
65785-034
11-digit product format
657850034
Labeler code
65785
Product ID
65785-034_445cd72e-831c-98c4-e063-6294a90a7bdc
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine gluconate and Propylene Glycol
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Niagara Pharmaceuticals Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-15
Substance
CHLORHEXIDINE GLUCONATE; PROPYLENE GLYCOL
Active strength
145.6; 280 kg/2800L; kg/2800L
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
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
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct65785-034UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65785-03465785-034-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
Eyewash Station Additive Concentrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE145.6 kg/2800L
PROPYLENE GLYCOL280 kg/2800L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup
6DC9Q167V3Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
362a6b6d-862d-4322-87a8-5b3a07fbe174Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65785-034-012023-02-21C16284748780-1f386c64a-201f-0266-e053-dadaa90a7c1aEYEWASH STATION ADDITIVE CONCENTRATE
65785-034-012023-01-30C16284748780-1f386c64a-201f-0266-e053-dadaa90a7c1aEYEWASH STATION ADDITIVE CONCENTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65785-034-01Eyewash Station Additive Concentrate0.236 L in 1 BOTTLE, UNIT-DOSELIQUID0.2368

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlorhexidine gluconateACTIVE INGREDIENTMOR84MUD8EEYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]1
Propylene GlycolACTIVE INGREDIENT6DC9Q167V3EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]1
ChlorhexidineACTIVE MOIETYR4KO0DY52LEYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]1
Propylene GlycolACTIVE MOIETY6DC9Q167V3EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]1
WaterINACTIVE INGREDIENT059QF0KO0REYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65785-034EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 1 package rows20250115_362a6b6d-862d-4322-87a8-5b3a07fbe174.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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
application number: M018
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
application number: M018
Visine A.C. Itchy Eye ReliefTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC257b9666-0163-499b-9673-bf6f4d6899b12024-11-13WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
application number: M018
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
application number: M018
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
application number: M018
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
application number: M018
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65785-034-0165785003401.236 L in 1 BOTTLE, UNIT-DOSE (65785-034-01) 2011-11-150000-00-00NoNoCurrent