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 |
|---|---|---|---|---|---|---|
| Vis Guard Lubricant Eye Drops | POLYVINYL ALCOHOL 1.4% | Ulai Health LLC | e9b0ed39-60c8-1093-e053-2a95a90a705b | 2026-01-13 | Warnings | M018 |
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | AvPAK | b4697319-438e-2ec8-e053-2a95a90abb56 | 2026-01-08 | Warnings | M018 |
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | AvPAK | b478a695-ded0-2e5f-e053-2995a90ac45e | 2026-01-08 | Warnings | M018 |
| Lubricant Eye Drops Solution | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | AvPAK | f5743b38-e3d2-a065-e053-2995a90a4b9a | 2026-01-08 | Warnings | M018 |
| Plus Rinse Emergency Eyewash | PURIFIED WATER | INNOVATIVE SAFETY SUPPLY INC. | b3f47d26-39e4-4aea-bb92-358def52b652 | 2026-01-08 | Warnings | M018 |
| pH Neutral Emergency Eyewash | WATER | INNOVATIVE SAFETY SUPPLY INC. | 29a1bd1e-d0dd-478f-e063-6394a90ab0aa | 2026-01-08 | Warnings | M018 |
| Polyvinyl Alcohol Eye Drops 1,4 % w/v | POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V | Aurolab | e8e09719-6e06-612b-e053-2995a90a79fc | 2026-01-08 | Warnings | M018 |
| Aurovisc | HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V | Aurolab | e9100312-b105-50a6-e053-2a95a90ac31f | 2026-01-08 | Warnings | M018 |
| TheraTears Dry and Tired | CARBOXYMETHYLCELLULOSE SODIUM | MEDTECH PRODUCTS INC | 02b70e2d-8159-4637-a282-9eac1468e786 | 2026-01-07 | Warnings | M018 |
| VISTA Hypromellose Dry Eye Relief | HYPROMELLOSE | Red Wedding LLC | b2c4954c-ed53-778a-e053-2a95a90ae0d0 | 2026-01-01 | Warnings | M018 |
| Colirio Ojo De Aguila Eye Drops | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Grandall Distributing Co., Inc. | 31aa07e9-0cc9-2a77-e063-6394a90a4b9d | 2025-12-31 | Warnings | M018 |
| Value Health by Prodose Eye Drops | TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 | Prodose, Inc. | 3fafa362-a8a6-3f91-e063-6394a90a98b3 | 2025-12-31 | Warnings | M018 |
| Signature Care Eye Drops High Performance | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Better Living Brands LLC | 6f1f4f58-3208-4b06-9afb-c4beeed09314 | 2025-12-30 | Warnings | M018 |
| Target Lubricant Eye Drops High Performance | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Target Corporation | 6c449374-8847-4c4a-9073-1951ff31d404 | 2025-12-30 | Warnings | M018 |
| Target Lubricant Eye Drops High Performance | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Target Corporation | ddc15dac-fbd8-42fa-80db-79f49fc6b9eb | 2025-12-30 | Warnings | M018 |
| Nighttime Relief Lubricant | LIGHT MINERAL OIL, WHITE PETROLATUM | Amerisource Bergen Drug Corp. | fd6b2be8-7e00-3765-e053-6294a90a4061 | 2025-12-30 | Warnings | M018 |
| Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Rugby Laboratories | fb84fc0b-9a62-812a-e053-6394a90aba0a | 2025-12-30 | Warnings | M018 |
| Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops | POLYVINYL ALCOHOL | Rugby Laboratories | 081673b2-5c74-1200-e063-6394a90ae363 | 2025-12-30 | Warnings | M018 |
| Medi-First Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Unifirst First Aid Corporation | a4e651cc-adf0-af9e-e053-2995a90ace5a | 2025-12-30 | Warnings | M018 |
| Green Guard Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | UniFirst First Aid Corporation | c3f04fdb-9fc1-797d-e053-2995a90afe80 | 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 |