SYSTANE HYDRATION PF PRESERVATIVE FREE
- Product NDC
- 0065-1510
- 11-digit product format
- 000651510
- Labeler code
- 0065
- Product ID
- 0065-1510_aeb3df48-7af2-464e-a87d-fe9027452a85
- 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
- 2021-02-01
- 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 HYDRATION PF 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 |
|---|
| 0065-1510-00 | SYSTANE HYDRATION PF PRESERVATIVE FREE | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 8 |
| 0065-1510-00 | SYSTANE HYDRATION PF PRESERVATIVE FREE | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | | 8 |
| 0065-1510-06 | SYSTANE HYDRATION PF PRESERVATIVE FREE | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 8 |
| 0065-1510-06 | SYSTANE HYDRATION PF PRESERVATIVE FREE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-1510 | SYSTANE HYDRATION PF PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20231117_8936f66f-10fe-44ab-a26e-dd8b05dfa997.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 |
|---|
| 0065-1510-00 | 00065151000 | 2 BOTTLE in 1 CARTON (0065-1510-00) / 10 mL in 1 BOTTLE | 2 bottle | 2023-01-11 | | No | No | Historical |
| 0065-1510-06 | 00065151006 | 1 BOTTLE in 1 CARTON (0065-1510-06) / 10 mL in 1 BOTTLE | 1 bottle | 2021-02-01 | 0000-00-00 | No | No | Current |