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 | 2026-10-12 | |
| excluded package | package | 0065-0429 | 0065-0429-36 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 0065-0429 | 0065-0429-67 | 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 | 0065-0429-67 | 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 |
|---|---|---|---|---|---|---|
| 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 | 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 |