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#

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 22 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Maximum Redness Relief and LubricantGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9feb1818-c79b-23bf-e053-2995a90a10842023-12-22WarningsExact identifier
application number: M018
Meijer Redness ReliefTETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea27a5-b81b-1598-e053-2995a90a6b622023-12-22WarningsExact identifier
application number: M018
Meijer Seasonal Itching and Redness ReliefTETRAHYDROZOLINE HCI, ZINC SULFATEMeijer Distribution, Inc.9fead2de-2fe6-4dab-e053-2995a90a27422023-12-22WarningsExact identifier
application number: M018
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
application number: M018
Meijer Redness ReliefGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9fea4e43-7525-bb66-e053-2a95a90acee92023-12-22WarningsExact identifier
application number: M018
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
application number: M018
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
application number: M018
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
application number: M018
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Maximum Redness Relief 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company949d4a4d-b0f8-81f8-e053-2995a90a818d2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Seasonal Relief 15mLTETRAHYDROZOLINE HCI, ZINC SULFATEWalgreen Co.947f3706-ef5e-2c53-e053-2a95a90a82bd2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMWalgreen Company9912b773-e7a5-3a82-e053-2995a90a5b2c2023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
application number: M018
Walgreens Redness Relief Eye Drops 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company94a0d08a-a6db-1088-e053-2995a90ab4fd2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Original 15mL and twin packTETRAHYDROZOLINE HCIWalgreens Company94e391f7-db4b-47d2-e053-2a95a90a1b112023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
application number: M018
Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation454ce049-49e5-48b1-8499-048e5e7d72d32023-12-20WarningsExact identifier
application number: M018
Rugby Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesf9292d5d-e0a3-9287-e053-6294a90a43e92023-12-20WarningsExact 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