Home NDC 65785-034 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 65785-034 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65785-034 65785-034-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…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 Ingredient Strength CHLORHEXIDINE GLUCONATE 145.6 kg/2800L PROPYLENE GLYCOL 280 kg/2800L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MOR84MUD8E Internal UNII lookup 6DC9Q167V3 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65785-034-01 Eyewash Station Additive Concentrate 0.236 L in 1 BOTTLE, UNIT-DOSE LIQUID 0.236 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65785-034 EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250115_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 6 of 25 · 499 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65785-034-01 65785003401 .236 L in 1 BOTTLE, UNIT-DOSE (65785-034-01) 2011-11-15 0000-00-00 No No Current