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 |
|---|---|---|---|---|---|---|
| Refresh Relieva | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | Allergan, Inc. | 6b984fa2-4187-45ef-b7d3-15e720abc667 | 2025-09-15 | Warnings | M018 |
| Dry eye relief | POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL | CARDINAL HEALTH 110, LLC. DBA LEADER | f8da3af5-9172-4023-be82-0fd5bd891616 | 2025-09-12 | Warnings | M018 |
| Oasis Tears PF Preservative-Free Lubricant Eye | GLYCERIN | OASIS Medical, Inc. | 640f95f4-c2e8-48ad-ad40-f76bbaddb0dc | 2025-09-12 | Warnings | M018 |
| Lubricant Drops | CARBOXYMETHYLCELLULOSE SODIUM | CARDINAL HEALTH 110, LLC. DBA LEADER | 1ac2fe24-9ff6-48c1-b123-fbc0e48f5304 | 2025-09-12 | Warnings | M018 |
| Eyes Irritation Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | CARDINAL HEALTH 110, LLC. DBA LEADER | bd2608c6-ffdf-352a-e053-2995a90a26a8 | 2025-09-12 | Warnings | M018 |
| Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM | CARDINAL HEALTH 110, LLC. DBA LEADER | bd262028-32e9-052d-e053-2a95a90a5303 | 2025-09-12 | Warnings | M018 |
| Oasis TEARS PF PLUS Preservative-Free Lubricant Eye | GLYCERIN | OASIS Medical, Inc. | 5d080191-423d-4c0a-b5ae-2ccf5c4a67cb | 2025-09-08 | Warnings | M018 |
| Physicians Care Eyewash | EYEWASH | Acme United Corporation | 3e239b12-9a75-339d-e063-6294a90a72ae | 2025-09-06 | Warnings | M018 |
| Splash Refresh | HYPROMELLOSE | LABORATORIOS SOPHIA, S.A. DE C.V. | 3c1c453e-2644-622a-e063-6394a90a8a94 | 2025-09-02 | Warnings | M018 |
| Refresh RELIEVA PF | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | d5d3df4a-a311-4f2d-9a24-edfec1a6c9f9 | 2025-08-22 | Warnings | M018 |
| Refresh Optive | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | Allergan, Inc. | 37e99aa8-02d6-4efb-a862-90bc7fcd5ca5 | 2025-08-22 | Warnings | M018 |
| Stye | MINERAL OIL AND PETROLATUM | Insight Pharmaceuticals LLC | f7eb8466-d8ea-4833-9bed-244ead38a3bf | 2025-08-11 | Warnings | M018 |
| Systane COMPLETE | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 2df0de02-a3e2-471a-9e10-040c3fba75fe | 2025-08-08 | Warnings | M018 |
| Medics Choice Fresh and Soothe | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | Unimed | 3bcd8394-f486-d306-e063-6294a90a4e9a | 2025-08-07 | Warnings | M018 |
| Systane Balance | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | c7b1a03a-a5f2-409e-a34a-d6f166671de5 | 2025-08-07 | Warnings | M018 |
| Medics Choice Fresh and Soothe | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | KC Pharmaceuticals, Inc. | 3bc03d54-6b31-5921-e063-6294a90af599 | 2025-08-01 | Warnings | M018 |
| LubriFresh PM | LIGHT MINERAL OIL, WHITE PETROLATUM | Hanlim Pharm Co. , LTD | 3b329232-a562-6893-e063-6394a90aa41f | 2025-07-31 | Warnings | M018 |
| Systane Ultra | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 0537c23a-15f7-be64-1231-a6c93468e9a8 | 2025-07-30 | Warnings | M018 |
| Systane | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 1d679d0f-cec2-a644-79cd-079607254bb9 | 2025-07-30 | Warnings | M018 |
| Systane Ultra Preservative Free | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 751fb85f-6683-4b0a-a650-324d4a74c5de | 2025-07-30 | 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 | 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 |