Eyewash Station Additive Concentrate
- Product NDC
- 78641-785
- 11-digit product format
- 786410785
- Labeler code
- 78641
- Product ID
- 78641-785_56b96cad-c6d1-3ad9-e063-6394a90ab92a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorhexidine gluconate and Propylene Glycol
- Dosage form
- LIQUID
- Route
- OPHTHALMIC
- Labeler
- Global Equipment Company
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-05
- 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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78641-785-63 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78641-785-63 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78641-785-63 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78641-785-63 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78641-785-63 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78641-785-63 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 78641-785-63 | U | Excluded because listing certification expired | 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 |
|---|---|
| bc93a1e8-aa3c-6735-e053-2995a90ad6e8 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78641-785-63 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-85cf-d83d-e063-dadaa90ab31f | EYEWASH STATION ADDITIVE CONCENTRATE |
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 |
|---|---|---|---|---|---|---|
| OASIS Tears Preservative-Free Lubricant Eye | GLYCERIN | OASIS Medical, Inc. | d9d71b1d-82a6-42e7-9ef2-2d041daef936 | 2024-12-23 | Warnings | M018 |
| Ancient Secrets Breathe Again | SODIUM CHLORIDE | LOTUS BRANDS, INC. | c6d2bab0-d363-4c09-a71b-ae15db915b37 | 2024-12-18 | Warnings | M018 |
| TheraTears Extra | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | MEDTECH PRODUCTS INC | 77f504c1-b8e0-4371-ac3e-9d453d84714b | 2024-12-13 | Warnings | M018 |
| TheraTears Extra | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | MEDTECH PRODUCTS INC | f1845041-9d8d-42a0-a2cb-68def7a5aac7 | 2024-12-13 | Warnings | M018 |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | M018 |
| Systane Nighttime | MINERAL OIL AND WHITE PETROLATUM | Alcon Laboratories, Inc. | 4689c59c-5721-3f91-6c85-e41501998fd0 | 2024-12-05 | Warnings | M018 |
| GenTeal Tears NIGHT-TIME | MINERAL OIL, WHITE PETROLATUM | Alcon Laboratories, Inc. | 9d5998a7-4f59-4293-87da-8419650a524d | 2024-12-05 | Warnings | M018 |
| Visine Red Eye Total Comfort and Tears Dry Eye Relief | TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE | Kenvue Brands LLC | 0bc0d6e7-9195-db6b-e063-6294a90aef04 | 2024-11-14 | Warnings | M018 |
| Visine Red Eye Comfort | TETRAHYDROZOLINE HYDROCHLORIDE | Kenvue Brands LLC | d7abd7cb-e094-481f-bea5-a5983e2c9ef4 | 2024-11-13 | Warnings | M018 |
| Visine Red Eye Hydrating Comfort Eye Drops | TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | a9a90de6-3172-4d34-984b-f4442f880e3d | 2024-11-13 | Warnings | M018 |
| Visine Dry Eye Relief | POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | 2de7a41d-661d-495f-89b4-5690664a3a3d | 2024-11-13 | Warnings | M018 |
| Visine Dry Eye Relief Eye Drops | POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | d9d3f000-3ce4-4ba2-a7fb-491b44eb3fa1 | 2024-11-13 | Warnings | M018 |
| Visine Dry Eye Relief | POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | a4c57620-778f-4434-9105-ead2f85c5884 | 2024-11-13 | Warnings | M018 |
| Visine A.C. Itchy Eye Relief | TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM | Kenvue Brands LLC | 257b9666-0163-499b-9673-bf6f4d6899b1 | 2024-11-13 | Warnings | M018 |
| Eyewash Station Additive Concentrate | CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL | Acme United Corporation | f19fbe28-b928-7c6e-e053-2995a90a43cb | 2024-11-09 | Warnings | M018 |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | M018 |
| Clear Eyes Triple Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 1269a1a6-843d-4d08-bb3c-c1f3d2e7080d | 2024-10-25 | Warnings | M018 |
| Clear Eyes Cooling Redness Relief | GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 38d14e99-e4c8-431b-b106-578eeb38bf3c | 2024-10-25 | Warnings | M018 |
| EyS Eye Wash | WATER | Eyes-Plus LLC | 1443f6bf-3a77-4a19-8585-0ec58efe042f | 2024-10-15 | Warnings | M018 |
| Eye Wash | WATER SOLUTION | Kroger Company | 354402ad-581d-47e7-9fd3-933bef281ff4 | 2024-10-11 | Warnings | M018 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 78641-785-63 | 78641078563 | .236 L in 1 BOTTLE, PLASTIC (78641-785-63) | 2021-03-05 | 0000-00-00 | No | No | Current |
| 78641-785-67 | 78641078567 | .236 L in 1 BOTTLE, PLASTIC (78641-785-67) | 2021-03-05 | 0000-00-00 | No | No | Current |
| 78641-785-68 | 78641078568 | .236 L in 1 BOTTLE, PLASTIC (78641-785-68) | 2021-03-05 | 0000-00-00 | No | No | Current |