splash refresh

Generic: hypromellose

Labeler: laboratorios sophia, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name splash refresh
Generic Name hypromellose
Labeler laboratorios sophia, s.a. de c.v.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

hypromellose 2910 (4000 mpa.s) .2 g/100mL

Manufacturer
LABORATORIOS SOPHIA, S.A. DE C.V.

Identifiers & Regulatory

Product NDC 57619-305
Product ID 57619-305_3dd7b774-826e-4155-e063-6394a90ad5bd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2025-08-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57619305
Hyphenated Format 57619-305

Supplemental Identifiers

RxCUI
359634
UNII
RN3152OP35

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name splash refresh (source: ndc)
Generic Name hypromellose (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .2 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (57619-305-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

57619-305-01 1 BOTTLE, DROPPER in 1 CARTON (57619-305-01) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

hypromellose 2910 (4000 mpa.s) (.2 g/100mL)

Linked Drug Pages (1)

Splash Refresh ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3dd7b774-826e-4155-e063-6394a90ad5bd", "openfda": {"unii": ["RN3152OP35"], "rxcui": ["359634"], "spl_set_id": ["3c1c453e-2644-622a-e063-6394a90a8a94"], "manufacturer_name": ["LABORATORIOS SOPHIA, S.A. DE C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (57619-305-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "57619-305-01", "marketing_start_date": "20250808"}], "brand_name": "Splash Refresh", "product_id": "57619-305_3dd7b774-826e-4155-e063-6394a90ad5bd", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "57619-305", "generic_name": "Hypromellose", "labeler_name": "LABORATORIOS SOPHIA, S.A. DE C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Splash Refresh", "active_ingredients": [{"name": "HYPROMELLOSE 2910 (4000 MPA.S)", "strength": ".2 g/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250808", "listing_expiration_date": "20261231"}