Splash Redness Reliever
- Product NDC
- 57619-304
- 11-digit product format
- 576190304
- Labeler code
- 57619
- Product ID
- 57619-304_351e11b7-7c46-9bc7-e063-6294a90a46a7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hypromellose, Naphazoline hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- LABORATORIOS SOPHIA, S.A. DE C.V.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-04-25
- Substance
- HYPROMELLOSE 2910 (4000 MPA.S); NAPHAZOLINE HYDROCHLORIDE
- Active strength
- .2; .02 g/100mL; 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 Redness Reliever
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYPROMELLOSE 2910 (4000 MPA.S) | .2 g/100mL |
| NAPHAZOLINE HYDROCHLORIDE | .02 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RN3152OP35, MZ1131787D |
| Rxcui | 2636530 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57619-304-01 | Splash Redness Reliever | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 57619-304-01 | Splash Redness Reliever | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57619-304 | SPLASH REDNESS RELIEVER (HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] | 4 | Current NDC, 2 package rows | 20250521_fa4140e6-dc80-da99-e053-6294a90a194f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57619-304-01 | 57619030401 | 1 BOTTLE, PLASTIC in 1 CARTON (57619-304-01) / 15 mL in 1 BOTTLE, PLASTIC | 2023-04-25 | No | No | Current |