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 | 2026-10-12 | |
| excluded package | package | 0065-1432 | 0065-1432-02 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 0065-1432 | 0065-1432-03 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| EYE DROPS | CARBOXYMETHYLCELLULOSE SODIUM | Foshan Sugar Max Cosmetics CO.,Ltd | 26dbf100-593e-3778-e063-6394a90adf26 | 2025-12-30 | Warnings | M018 |
| GoodSense Eye Drops Original Formula | TETRAHYDROZOLINE HCL | Geiss, Destin & Dunn, Inc. | 9b44de58-6362-3811-e053-2995a90a2f37 | 2025-12-30 | Warnings | M018 |
| GoodSense Redness Relief Plus | GLLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Geiss, Destin & Dunn, Inc. | 9b37250f-9bdf-574e-e053-2a95a90a013e | 2025-12-30 | Warnings | M018 |
| CVS Advanced Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | CVS Pharmacy, Inc. | f74a2fca-902c-f68a-e053-6394a90abb88 | 2025-12-30 | Warnings | M018 |
| GoodSense Eye Drops Irritation Relief | TETRAHYDROZOLINE HCL, ZINC SULFATE | Geiss, Destin & Dunn, Inc. | 9b24fbdd-780c-1ba2-e053-2a95a90ad60f | 2025-12-30 | Warnings | M018 |
| CVS Hydration Eye Drops | POLYETYLENE GLYCOL 400, PROPYLENE GLYCOL | CVS | ecab8fa3-6575-0dde-e053-2a95a90abd61 | 2025-12-30 | Warnings | M018 |
| Good Sense Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Geiss, Destin & Dunn, Inc. | 9b243301-2e4b-5706-e053-2995a90a9b90 | 2025-12-30 | Warnings | M018 |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Geiss, Derstin & Dunn, Inc. | 9b34de99-13df-201a-e053-2a95a90ae559 | 2025-12-30 | Warnings | M018 |
| Good Sense Lubricating Plus Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | GoodSense | ffd6428e-3bf5-8742-e053-6394a90a4c8f | 2025-12-30 | Warnings | M018 |
| GoodSense Ultra Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Geiss, Destin & Dunn, Inc. | 9b45ebb5-c43b-c9fb-e053-2a95a90a3411 | 2025-12-30 | Warnings | M018 |
| CVS Maximum Redness Relief | GLYCERIN, NAPHAZOLINE HCI | CVS Pharmacy, Inc. | f70f9fc4-4022-336e-e053-6394a90a4d07 | 2025-12-30 | Warnings | M018 |
| Discount Drug Mart Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Discount Drug Mart, Inc. | f75c2f84-a28c-5807-e053-6294a90a2295 | 2025-12-30 | Warnings | M018 |
| Discount Drug Mart Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Discount Drug Mart | f7fd53be-e501-d97f-e053-6394a90ad409 | 2025-12-30 | Warnings | M018 |
| Discount Drug Mart Eye Drops A.C. | TETRAHYDROZOLINE HCL, ZINC SULFATE | Discount Drug Mart | f5f1d3da-5300-8211-e053-2a95a90a323a | 2025-12-30 | Warnings | M018 |
| Exchange Select Eye Drops Advanced Relief Moisturizer | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Army and Air Force Exchange Service | 9e475240-2df1-9bee-e053-2995a90a8d4b | 2025-12-30 | Warnings | M018 |
| Family Wellness Maximum Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCL | Family Dollar Services, Inc. | facd53c4-9cfc-6589-e053-6394a90a180d | 2025-12-30 | Warnings | M018 |
| Exchange Select Artificial Tears Lubricant Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Army and Air Force Exchange Service | 9e478343-8ae7-823e-e053-2995a90a84ed | 2025-12-30 | Warnings | M018 |
| Family Wellness Advanced Redness Relief Eye Drops | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL | Family Dollar Services, Inc. | fabec215-a040-3f4e-e053-6394a90ad45f | 2025-12-30 | Warnings | M018 |
| Family Wellness Original Redness Relief Eye Drops | TETRAHYDROZOLINE HCL | Family Dollar Services, Inc. | fabf540a-8d5c-bb1c-e053-6394a90a75c2 | 2025-12-30 | Warnings | M018 |
| Family Wellness Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Family Dollar Services, Inc. | facd329b-1923-61df-e053-6294a90ab738 | 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 |