Systane
- Product NDC
- 0065-0431
- 11-digit product format
- 000650431
- Labeler code
- 0065
- Product ID
- 0065-0431_5c7432b0-b4b8-49a1-89b7-6e3befa25917
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- polyethylene glycol and propylene glycol
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Research Ltd
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-10-30
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Systane
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 400 | 4 mg/mL |
| PROPYLENE GLYCOL | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B697894SGQ, 6DC9Q167V3 |
| Rxcui | 477589 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0431 | SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD] | 11 | Current NDC, Legacy NDC, 8 package rows | 20231216_14916d2c-a63d-491e-bd91-a61f300af38a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-0431-04 | 00065043104 | 0.4 mL in 1 VIAL | 0.4 ml | | | | | Historical |
| 0065-0431-32 | 00065043132 | 0.4 mL in 1 VIAL | 0.4 ml | | | | | Historical |
| 0065-0431-33 | 00065043133 | 30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIAL | 30 vial | 2015-10-30 | 0000-00-00 | No | No | Current |
| 0065-0431-57 | 00065043157 | 40 in 1 CARTON | | | | | | Historical |