Splash Tears
- Product NDC
- 57619-303
- 11-digit product format
- 576190303
- Labeler code
- 57619
- Product ID
- 57619-303_350b4cce-1629-5b8f-e063-6294a90aa6bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hypromellose
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- LABORATORIOS SOPHIA, S.A. DE C.V.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-05-13
- Substance
- HYPROMELLOSE 2910 (4000 MPA.S)
- Active strength
- .2 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Splash Tears
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYPROMELLOSE 2910 (4000 MPA.S) | .2 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RN3152OP35 |
| Rxcui | 359634 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57619-303-01 | Splash Tears | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 9 |
| 57619-303-01 | Splash Tears | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 9 |
| 57619-303-03 | Splash Tears | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 9 |
| 57619-303-03 | Splash Tears | 2 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57619-303 | SPLASH TEARS (HYPROMELLOSE) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250521_a58a8478-9cc5-aa39-e053-2995a90a347d.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 |
|---|
| 57619-303-01 | 57619030301 | 1 BOTTLE, DROPPER in 1 CARTON (57619-303-01) / 15 mL in 1 BOTTLE, DROPPER | 2020-05-13 | 0000-00-00 | No | No | Current |
| 57619-303-03 | 57619030303 | 1 BOTTLE, DROPPER in 1 CARTON (57619-303-03) / 2 mL in 1 BOTTLE, DROPPER | 2020-07-24 | 0000-00-00 | Yes | No | Current |