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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Systane Lubricant
- 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#
Package NDC, Product, Description table| 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Polyethylene Glycol 400 | ACTIVE INGREDIENT | B697894SGQ | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Propylene Glycol | ACTIVE INGREDIENT | 6DC9Q167V3 | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Polyethylene Glycol 400 | ACTIVE MOIETY | B697894SGQ | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Propylene Glycol | ACTIVE MOIETY | 6DC9Q167V3 | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Boric Acid | INACTIVE INGREDIENT | R57ZHV85D4 | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Calcium Chloride | INACTIVE INGREDIENT | M4I0D6VV5M | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Guar Gum | INACTIVE INGREDIENT | E89I1637KE | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Magnesium Chloride | INACTIVE INGREDIENT | 02F3473H9O | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Polidronium Chloride | INACTIVE INGREDIENT | 6716Z5YR3G | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Potassium Chloride | INACTIVE INGREDIENT | 660YQ98I10 | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
| Zinc Chloride | INACTIVE INGREDIENT | 86Q357L16B | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0429 | SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 14 | Current NDC, Legacy NDC, 10 package rows | 20231216_15bc06ec-f3dc-3180-ca1a-106769a770ea.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 |
|---|
| 0065-0429-15 | 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 |