SilkTears
- Product NDC
- 85837-0001
- 11-digit product format
- 858370001
- Labeler code
- 85837
- Product ID
- 85837-0001_3a112f65-f676-a200-e063-6294a90a7ba4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Glycerin ophthalmic solution
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- SilkTears
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-25
- Substance
- GLYCERIN
- Active strength
- 2 mg/1000mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SilkTears
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCERIN | 2 mg/1000mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PDC6A3C0OX |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85837-0001-3 | SilkTears | 30 in 1 BOX | SOLUTION/ DROPS | 30 | | 4 |
| 85837-0001-3 | SilkTears | 0.4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 0.4 | | 4 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85837-0001-3 | 85837000103 | 30 VIAL, SINGLE-USE in 1 BOX (85837-0001-3) / .4 mL in 1 VIAL, SINGLE-USE | 2025-06-25 | No | No | Historical |