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.
| 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 |
|---|---|
| CHLORHEXIDINE GLUCONATE | 145.6 kg/2800L |
| PROPYLENE GLYCOL | 280 kg/2800L |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| MOR84MUD8E | Internal UNII lookup |
| 6DC9Q167V3 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362a6b6d-862d-4322-87a8-5b3a07fbe174 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65785-034-01 | 2023-02-21 | C162847 | 48780-1 | f386c64a-201f-0266-e053-dadaa90a7c1a | EYEWASH STATION ADDITIVE CONCENTRATE |
| 65785-034-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-201f-0266-e053-dadaa90a7c1a | EYEWASH STATION ADDITIVE CONCENTRATE |
DailyMed Package Descriptions#
| 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#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Chlorhexidine gluconate | ACTIVE INGREDIENT | MOR84MUD8E | EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.] | 1 | |
| Propylene Glycol | ACTIVE INGREDIENT | 6DC9Q167V3 | EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.] | 1 | |
| Chlorhexidine | ACTIVE MOIETY | R4KO0DY52L | EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.] | 1 | |
| Propylene Glycol | ACTIVE MOIETY | 6DC9Q167V3 | EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | AvPAK | b479d2ae-4b59-916a-e053-2995a90af8ec | 2025-11-11 | Warnings | M018 |
| Sodium Chloride | SODIUM CHLORIDE | Rising Pharma Holdings, Inc. | 42870188-b1d7-4934-a6c0-310530497dac | 2025-11-07 | Warnings | M018 |
| Systane Complete PF | PROPYLENE GLYCOL EMULSION | Alcon Laboratories, Inc. | 798ffdde-1dba-4a3f-a0b6-937f9e958cca | 2025-11-03 | Warnings | M018 |
| LACRIFRESH HYDRAPF | GLYCERIN, POVIDONE | AVIZOR, S.A. | 41bbd23e-0ec8-eb18-e063-6294a90a46d1 | 2025-10-27 | Warnings | M018 |
| LACRIFRESH HYDRAMAXPF | GLYCERIN, POVIDONE | AVIZOR, S.A. | 41be1604-89b4-7ec3-e063-6294a90a3331 | 2025-10-27 | Warnings | M018 |
| Up and Up Dry Eye Relief Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Target Corporation | 3b1834e6-75cf-5380-e063-6294a90ad1d5 | 2025-10-25 | Warnings | M018 |
| Up and Up Dry Eye Relief Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Hanlim | 420274c6-7bf0-0920-e063-6294a90a30be | 2025-10-25 | Warnings | M018 |
| Stye | POLYVINYL ALCOHOL AND POVIDONE | Medtech Products Inc. | 60c11d3d-df20-4d1c-b425-49a84fecea30 | 2025-10-23 | Warnings | M018 |
| TheraTears Lubricant | CARBOXYMETHYLCELLULOSE SODIUM | MEDTECH PRODUCTS INC | 797b0394-2f0f-4733-8d20-ec5bdf3e085d | 2025-10-23 | Warnings | M018 |
| Advanced Eye Relief Dry Eye Rejuvenation | GLYCERIN PROPYLENE GLYCOL | Bausch & Lomb Incorporated | 027969ee-64e4-4b08-bab7-c4cc8ed22f5f | 2025-10-23 | Warnings | M018 |
| TheraTears Lubricant | CARBOXYMETHYLCELLULOSE SODIUM | MEDTECH PRODUCTS INC | 661d8764-8ae6-4229-9485-867553ee8e16 | 2025-10-23 | Warnings | M018 |
| Refresh Relieva Preservative Free | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 3481f9b3-5a90-40d3-80f8-81f51cc864be | 2025-10-22 | Warnings | M018 |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Method Pharmaceuticals | ce84727a-3677-4bf0-e053-2995a90a3ec8 | 2025-10-21 | Warnings | M018 |
| iVIZIA Dry Eye | POVIDONE | Thea Pharma Inc. | 1ef73cb1-da48-a713-e063-6294a90afa9d | 2025-10-20 | Warnings | M018 |
| Walgreens Ultra Lubricant | POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL | Walgreens | 21dfe061-4533-2061-e063-6394a90a6e73 | 2025-10-17 | Warnings | M018 |
| Walgreens | SODIUM CHLORIDE | Walgreen Company | 21dfc2cf-65ae-c3fb-e063-6294a90a0a94 | 2025-10-17 | M018 | |
| Xpect Industrial Eye Relief | GLYCERIN, NAPHAZOLINE HCL | Cintas Corporation | a0167d06-7adb-36f4-e053-2a95a90af9ef | 2025-09-30 | Warnings | M018 |
| Xpect Eyewash | EYEWASH | Cintas Corporation | 1d69365d-662b-4248-8fa9-1629451b549a | 2025-09-30 | Warnings | M018 |
| REFRESH OPTIVE Drops | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 80275190-d717-40ea-905b-5c8fbe986eac | 2025-09-15 | Warnings | M018 |
| Refresh Relieva PF Xtra | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | b51b8a75-8faa-430f-8f7e-ee58d3d13f2e | 2025-09-15 | Warnings | M018 |
Packages#
| 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 |