Systane
- Product NDC
- 0065-1432
- 11-digit product format
- 000651432
- Labeler code
- 0065
- Product ID
- 0065-1432_cce3e663-58ef-4ece-a6d2-c49ecc7ea9cb
- 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
- 2009-07-27
- 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
- Brand name suffix
- ULTRA
- 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#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Polyethylene Glycol 400 | ACTIVE INGREDIENT | B697894SGQ | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| PROPYLENE GLYCOL | ACTIVE INGREDIENT | 6DC9Q167V3 | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| Polyethylene Glycols | ACTIVE MOIETY | 3WJQ0SDW1A | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| PROPYLENE GLYCOL | ACTIVE MOIETY | 6DC9Q167V3 | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| Aminomethylpropanol | INACTIVE INGREDIENT | LU49E6626Q | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-1432 | SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 15 | Current NDC, Legacy NDC, 12 package rows | 20231216_a5c1c194-3db5-4f18-9cd1-97f7f84c3cff.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 |
|---|
| 0065-1432-01 | 00065143201 | 24 in 1 CARTON | | | | | | Historical |
| 0065-1432-02 | 00065143202 | 4 in 1 CARTON | | | | | | Historical |
| 0065-1432-03 | 00065143203 | 0.4 mL in 1 VIAL | 0.4 ml | | | | | Historical |
| 0065-1432-04 | 00065143204 | 5 VIAL in 1 CARTON (0065-1432-04) / .7 mL in 1 VIAL | 5 vial | 2009-07-27 | 0000-00-00 | No | No | Current |
| 0065-1432-05 | 00065143205 | 60 VIAL in 1 CARTON (0065-1432-05) / .7 mL in 1 VIAL | 60 vial | 2009-07-27 | 0000-00-00 | No | No | Current |
| 0065-1432-06 | 00065143206 | 25 VIAL in 1 CARTON (0065-1432-06) / .7 mL in 1 VIAL | 25 vial | 2009-07-27 | 0000-00-00 | No | No | Current |