Systane
- Product NDC
- 0065-1432
- 11-digit product format
- 000651432
- Labeler code
- 0065
- Product ID
- 0065-1432_cce3e663-58ef-4ece-a6d2-c49ecc7ea9cb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- polyethylene glycol 400 and propylene glycol
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-07-27
- Substance
- POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
- Active strength
- 4; 3 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0065-1432 | 0065-1432-01 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0065-1432 | 0065-1432-02 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0065-1432 | 0065-1432-03 | D | Discontinued by firm | 2026-10-15 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0065-1432-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0065-1432-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0065-1432-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0065-1432-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0065-1432-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0065-1432-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0065-1432-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0065-1432-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0065-1432-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0065-1432-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0065-1432-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0065-1432-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0065-1432-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0065-1432-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0065-1432-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0065-1432-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0065-1432-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0065-1432-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0065-1432-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0065-1432-03 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0065-1432-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0065-1432-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0065-1432-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0065-1432-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0065-1432-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0065-1432-03 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0065-1432-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0065-1432-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0065-1432-03 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0065-1432-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0065-1432-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0065-1432-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0065-1432-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0065-1432-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0065-1432-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0065-1432-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Systane
- Brand name suffix
- ULTRA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 400 | 4 mg/mL |
| PROPYLENE GLYCOL | 3 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| B697894SGQ | Internal UNII lookup |
| 6DC9Q167V3 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 477589 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a5c1c194-3db5-4f18-9cd1-97f7f84c3cff | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0065-1432-01 | SystaneULTRA | 24 in 1 CARTON | SOLUTION/ DROPS | 24 | 15 | |
| 0065-1432-01 | SystaneULTRA | 0.4 mL in 1 VIAL | SOLUTION/ DROPS | 0.4 | 15 | |
| 0065-1432-02 | SystaneULTRA | 4 in 1 CARTON | SOLUTION/ DROPS | 4 | 15 | |
| 0065-1432-02 | SystaneULTRA | 0.4 mL in 1 VIAL | SOLUTION/ DROPS | 0.4 | 15 | |
| 0065-1432-03 | SystaneULTRA | 0.4 mL in 1 VIAL | SOLUTION/ DROPS | 0.4 | 15 | |
| 0065-1432-03 | SystaneULTRA | 72 in 1 CARTON | SOLUTION/ DROPS | 72 | 15 | |
| 0065-1432-04 | SystaneULTRA | 5 in 1 CARTON | SOLUTION/ DROPS | 5 | 15 | |
| 0065-1432-04 | SystaneULTRA | .7 mL in 1 VIAL | SOLUTION/ DROPS | .7 | 15 | |
| 0065-1432-05 | SystaneULTRA | .7 mL in 1 VIAL | SOLUTION/ DROPS | .7 | 15 | |
| 0065-1432-05 | SystaneULTRA | 60 in 1 CARTON | SOLUTION/ DROPS | 60 | 15 | |
| 0065-1432-06 | SystaneULTRA | .7 mL in 1 VIAL | SOLUTION/ DROPS | .7 | 15 | |
| 0065-1432-06 | SystaneULTRA | 25 in 1 CARTON | SOLUTION/ DROPS | 25 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0065-1432-01 | EA - Each | 0065-1432 | 14f1c113-d43c-471c-89e7-cad2980b32cd | 1 | 2012-07-24 |
| 0065-1432-05 | EA - Each | 0065-1432 | 417bc31a-48fa-44c1-8b41-76c88a58e782 | 1 | 2018-08-13 |
| 0065-1432-06 | EA - Each | 0065-1432 | c4bb8e26-fe99-426e-a250-b66107f54fab | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Winco Original Formula Eye Drops | TETRAHYDROZOLINE HCL | WinCo Foods, LLC | 44266952-4054-4c12-b3fc-d0543fe54fe2 | 2025-12-30 | Warnings | M018 |
| Winco Irritation Relief Eye | TETRAHYDROZOLINE HCL, ZINC SULFATE | WinCo Foods, LLC | 60565184-5745-43a5-92b2-ab45b27e8bc6 | 2025-12-30 | Warnings | M018 |
| Core Values Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Liberty Procurement Co. Inc. | f8285f68-c40c-19a8-e053-6394a90aacad | 2025-12-30 | Warnings | M018 |
| Core Values Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Liberty Procurement Co., Inc. | f76dfeca-4e86-0b5d-e053-6294a90a29b9 | 2025-12-30 | Warnings | M018 |
| Best Choice Eye Drops A.C. | TETRAHYDROZOLINE HCL, ZINC SULFATE | Best Choice (Valu Merchandisers Company) | f5e665e4-ebd7-8c35-e053-2995a90a8811 | 2025-12-30 | Warnings | M018 |
| Harris Teeter Eye Drops Artificial Tears | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Harris Teeter, LLC. | f82957d9-c4ad-a914-e053-6294a90aac50 | 2025-12-30 | Warnings | M018 |
| Best Choice Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Valu Merchandisers, Co. | f7491a17-8035-5a3c-e053-6294a90a615c | 2025-12-30 | Warnings | M018 |
| Winco Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | WinCo Foods, LLC | f10778c8-14fe-4852-8b73-42db502fd2bc | 2025-12-30 | Warnings | M018 |
| Harris Teeter Eye Drops Maximum Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Harris Teeter, LLC | f710d107-0403-21c5-e053-6394a90a0372 | 2025-12-30 | Warnings | M018 |
| CVS Astringent Eye | TETRAHYDROZOLINE HCL, ZINC SULFATE | CVS Pharmacy, Inc. | 07e1a56b-fdad-408d-bf5a-7a0144ece131 | 2025-12-30 | Warnings | M018 |
| Harris Teeter Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Harris Teeter, LLC | f76e2831-5c6c-7a62-e053-6294a90a937b | 2025-12-30 | Warnings | M018 |
| CVS Gentle Tears | DEXTRAN 70, HYPROMELLOSE | CVS Pharmacy, Inc. | 9b1ea0eb-c34f-6603-e053-2995a90a6a95 | 2025-12-30 | Warnings | M018 |
| CVS Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | CVS Pharmacy, Inc. | 8eef499d-c60e-9468-e053-2995a90a8714 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Lubricating Tears Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Strategic Sourcing Services LLC | 0042337b-c22a-157a-e063-6394a90a202e | 2025-12-30 | Warnings | M018 |
| CVS Lubricant Eye Drops Original | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CVS | bb1ad35a-79ea-639f-e053-2995a90a96f3 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Advanced Relief Eye Drops | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL | Strategic Sourcing Services LLC | 0019cd99-b245-2ffc-e063-6294a90a9f27 | 2025-12-30 | Warnings | M018 |
| CVS Multi-Symptom Eye Drops | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE | CVS Pharmacy, Inc. | be3d7855-cc66-ace8-e053-2a95a90ab8f4 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Dry Eye Relief | POLYETHYLENE GLYCOL 400 | Strategic Sourcing Services LLC | 0018ade9-5856-db6c-e063-6394a90a2ccf | 2025-12-30 | Warnings | M018 |
| CareOne Itchy Relief Eye Drops 15mL | TETRAHYDROZOLINE HCI, ZINC SULFATE | Retail Business Services, LLC. | 997f16ff-2632-2e9d-e053-2995a90a6f51 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCL | Strategic Sourcing Services LLC | 0042e9a0-9693-d7e0-e063-6294a90ae6c6 | 2025-12-30 | Warnings | M018 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 477589 | polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic Solution | PSN | a5c1c194-3db5-4f18-9cd1-97f7f84c3cff | 15 |
| 477589 | polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution | SCD | a5c1c194-3db5-4f18-9cd1-97f7f84c3cff | 15 |
| 477589 | PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution | SY | a5c1c194-3db5-4f18-9cd1-97f7f84c3cff | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0065-1432-01 | 00065143201 | 24 in 1 CARTON | Historical | |||||
| 0065-1432-02 | 00065143202 | 4 in 1 CARTON | Historical | |||||
| 0065-1432-03 | 00065143203 | 0.4 mL in 1 VIAL | 0.4 ml | Historical | ||||
| 0065-1432-04 | 00065143204 | 5 VIAL in 1 CARTON (0065-1432-04) / .7 mL in 1 VIAL | 5 vial | 2009-07-27 | 0000-00-00 | No | No | Current |
| 0065-1432-05 | 00065143205 | 60 VIAL in 1 CARTON (0065-1432-05) / .7 mL in 1 VIAL | 60 vial | 2009-07-27 | 0000-00-00 | No | No | Current |
| 0065-1432-06 | 00065143206 | 25 VIAL in 1 CARTON (0065-1432-06) / .7 mL in 1 VIAL | 25 vial | 2009-07-27 | 0000-00-00 | No | No | Current |