Systane Lubricant
- Product NDC
- 0065-0429
- 11-digit product format
- 000650429
- Labeler code
- 0065
- Product ID
- 0065-0429_bbb16c95-87ac-4e07-8060-5e33e6dae0a6
- 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
- 2003-02-25
- 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 | 0065-0429 | 0065-0429-21 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0065-0429 | 0065-0429-36 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0065-0429 | 0065-0429-67 | 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 | 0065-0429-67 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0065-0429-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0065-0429-36 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0065-0429-67 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0065-0429-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0065-0429-36 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0065-0429-67 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0065-0429-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0065-0429-36 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0065-0429-67 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0065-0429-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0065-0429-36 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0065-0429-67 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0065-0429-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0065-0429-36 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0065-0429-67 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0065-0429-21 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0065-0429-36 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0065-0429-67 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0065-0429-21 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0065-0429-36 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0065-0429-67 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0065-0429-21 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0065-0429-36 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0065-0429-67 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0065-0429-21 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0065-0429-36 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0065-0429-67 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0065-0429-21 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0065-0429-36 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0065-0429-67 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0065-0429-21 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0065-0429-36 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0065-0429-67 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0065-0429-21 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0065-0429-36 | 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 Lubricant
- 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 |
|---|---|
| 15bc06ec-f3dc-3180-ca1a-106769a770ea | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0065-0429-15 | Systane Lubricant | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 14 | |
| 0065-0429-15 | Systane Lubricant | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 14 | |
| 0065-0429-21 | Systane Lubricant | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 14 | |
| 0065-0429-21 | Systane Lubricant | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 14 | |
| 0065-0429-30 | Systane Lubricant | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 14 | |
| 0065-0429-30 | Systane Lubricant | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 14 | |
| 0065-0429-36 | Systane Lubricant | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 14 | |
| 0065-0429-36 | Systane Lubricant | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 14 | |
| 0065-0429-67 | Systane Lubricant | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 14 | |
| 0065-0429-67 | Systane Lubricant | 20 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 20 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0065-0429-15 | ML - Milliliter | 0065-0429 | bfbc8274-26f8-4715-8bca-6c309150a994 | 1 | 2013-02-13 |
| 0065-0429-21 | ML - Milliliter | 0065-0429 | 60d63a5b-37c9-44cf-98fb-546ed34f4406 | 1 | 2016-05-16 |
| 0065-0429-30 | ML - Milliliter | 0065-0429 | 17dafaf4-abf3-40d7-b4ff-cd3694cc382b | 1 | 2016-05-16 |
| 0065-0429-36 | ML - Milliliter | 0065-0429 | 5c5d48f5-a0c5-48a0-a483-9fb3219c4517 | 1 | 2016-05-16 |
| 0065-0429-67 | ML - Milliliter | 0065-0429 | 1a7217dd-8f59-49a3-8ac4-f289a82f701c | 1 | 2016-05-16 |
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 |
|---|---|---|---|---|---|---|
| Clear Eyes Natural Tears | POLYVINYL ALCOHOL AND POVIDONE | Prestige Brands Holdings, Inc. | efba3eb0-798d-4635-b19b-4970e45b3cc9 | 2024-04-01 | Warnings | M018 |
| Polyvinyl Alcohol | POLYVINYL ALCOHOL | A-S Medication Solutions | c77589fd-f68d-48b7-bd12-51f6b4cc9402 | 2024-03-20 | Warnings | M018 |
| REFRESH CLASSIC | POLYVINYL ALCOHOL, POVIDONE | A-S Medication Solutions | 3bf6193c-56db-45ad-844c-58eb8c33cba9 | 2024-03-14 | Warnings | M018 |
| GOODSENSE ARTIFICIAL TEARS | POLYVINYL ALCOHOL | Proficient Rx LP | f29c792c-6cb2-449f-b97d-6304a58dec2a | 2024-02-01 | Warnings | M018 |
| GoodSense Artifical Tears | POLYVINYL ALCOHOL, AND POVIDONE | Proficient Rx LP | cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9 | 2024-02-01 | Warnings | M018 |
| GENTEAL TEARS | DEXTRAN 70, GLYCERIN, HYPROMELLOSE | A-S Medication Solutions | a2b715e9-332d-4f0b-b8e5-ebc000681586 | 2024-01-21 | Warnings | M018 |
| Visine Red Eye Hydrating Comfort, CVP | TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS | Lil' Drug Store Products, Inc. | 0f50bcc8-3658-8c2c-e063-6294a90a8e13 | 2024-01-19 | Warnings | M018 |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | b56ef662-fec2-4d94-e053-2995a90aba2b | 2024-01-06 | Warnings | M018 |
| Exchange Select Maximum Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCL | Army and Air Force Exchange Service | 318bc025-c936-a066-e063-6294a90a4712 | 2024-01-01 | Warnings | M018 |
| Kroger Eye Drops Original | TETRAHYDROZOLINE HCL | The Kroger Co. | 318c17a1-fe08-508b-e063-6394a90a2e08 | 2024-01-01 | Warnings | M018 |
| HEB Original Eye Drops | TETRAHYDROZOLINE HCL | HEB Grocery Company, LP | 318cb457-bb2d-a1ee-e063-6294a90a8019 | 2024-01-01 | Warnings | M018 |
| Discount Drug Mart Eye Drops Multi-Symptom Relief | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE | Discount Drug Mart, Inc. | 318dc92a-0707-d6a4-e063-6294a90ab78a | 2024-01-01 | Warnings | M018 |
| Kroger Eye Drops Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | The Kroger Co. | 318dea21-2656-36a3-e063-6294a90ac9c4 | 2024-01-01 | Warnings | M018 |
| Harris Teeter Eye Drops Original | TETRAHYDROZOLINE HCL | Harris Teeter, LLC.P | 31a1b962-27ad-97b1-e063-6294a90a77f1 | 2024-01-01 | Warnings | M018 |
| CVP Sterile Eye Drops | TETRAHYDROZOLINE HCL | Salado Sales, Inc. | 31a216f8-28e9-ec8f-e063-6394a90aec49 | 2024-01-01 | Warnings | M018 |
| Equaline Sterile Eye Drops | TETRAHYDROZOLINE HCL | United Natural Foods, Inc. | 31a25efb-a627-1a13-e063-6394a90a2ca3 | 2024-01-01 | Warnings | M018 |
| Best Choice Eye Drops Original | TETRAHYDROZOLINE HCL | Valu Merchandisers Company | 31a2a42a-bcfe-4f22-e063-6294a90ac60e | 2024-01-01 | Warnings | M018 |
| Discount Drug Mart Eye Drops Original | TETRAHYDROZOLINE HCL | Discount Drug Mart, Inc. | 31a2efb2-3924-6a12-e063-6394a90ab0e2 | 2024-01-01 | Warnings | M018 |
| Equaline Redness Relief Lubricant Eye Drops | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | United Natural Foods, Inc | 31a30b00-9f4b-717a-e063-6394a90a8a87 | 2024-01-01 | Warnings | M018 |
| Harris Teeter Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Harris Teeter, LLC. | 31a3d575-10f1-5feb-e063-6294a90ac478 | 2024-01-01 | 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 | 15bc06ec-f3dc-3180-ca1a-106769a770ea | 14 |
| 477589 | polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution | SCD | 15bc06ec-f3dc-3180-ca1a-106769a770ea | 14 |
| 477589 | PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution | SY | 15bc06ec-f3dc-3180-ca1a-106769a770ea | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0065-0429-15 | 00065042915 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0429-15) / 15 mL in 1 BOTTLE, DROPPER | 2003-02-25 | 0000-00-00 | No | No | Current | |
| 0065-0429-21 | 00065042921 | 2 BOTTLE, DROPPER in 1 CARTON (0065-0429-21) > 5 mL in 1 BOTTLE, DROPPER | 2003-02-25 | 0000-00-00 | No | No | Current | |
| 0065-0429-30 | 00065042930 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0429-30) / 30 mL in 1 BOTTLE, DROPPER | 2003-02-25 | 0000-00-00 | No | No | Current | |
| 0065-0429-36 | 00065042936 | 30 mL in 1 BOTTLE, DROPPER | 30 ml | Historical | ||||
| 0065-0429-67 | 00065042967 | 2 in 1 CARTON | Historical |