Systane Ultra Preservative Free
- Product NDC
- 0065-1507
- 11-digit product format
- 000651507
- Labeler code
- 0065
- Product ID
- 0065-1507_c459712f-30d9-4084-a6ff-f157d6e604a9
- 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
- 2022-02-15
- 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 Ultra Preservative Free
- 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 |
|---|
| 0065-1507-82 | Systane Ultra Preservative Free | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 5 |
| 0065-1507-82 | Systane Ultra Preservative Free | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
| 0065-1507-92 | Systane Ultra Preservative Free | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 5 |
| 0065-1507-92 | Systane Ultra Preservative Free | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-1507 | SYSTANE ULTRA PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231216_751fb85f-6683-4b0a-a650-324d4a74c5de.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-1507-82 | 00065150782 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1507-82) / 10 mL in 1 BOTTLE, DROPPER | 2022-02-15 | 0000-00-00 | No | No | Current |
| 0065-1507-92 | 00065150792 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1507-92) / 10 mL in 1 BOTTLE, DROPPER | 2023-04-11 | | No | No | Current |