splash redness reliever

Generic: hypromellose, naphazoline hydrochloride

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 redness reliever
Generic Name hypromellose, naphazoline hydrochloride
Labeler laboratorios sophia, s.a. de c.v.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

hypromellose 2910 (4000 mpa.s) .2 g/100mL, naphazoline hydrochloride .02 g/100mL

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

Identifiers & Regulatory

Product NDC 57619-304
Product ID 57619-304_351e11b7-7c46-9bc7-e063-6294a90a46a7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2023-04-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57619304
Hyphenated Format 57619-304

Supplemental Identifiers

RxCUI
2636530
UNII
RN3152OP35 MZ1131787D

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 redness reliever (source: ndc)
Generic Name hypromellose, naphazoline hydrochloride (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .2 g/100mL
  • .02 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (57619-304-01) / 15 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

57619-304-01 1 BOTTLE, PLASTIC in 1 CARTON (57619-304-01) / 15 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

hypromellose 2910 (4000 mpa.s) (.2 g/100mL) naphazoline hydrochloride (.02 g/100mL)

Linked Drug Pages (1)

Splash Redness Reliever ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "351e11b7-7c46-9bc7-e063-6294a90a46a7", "openfda": {"unii": ["RN3152OP35", "MZ1131787D"], "rxcui": ["2636530"], "spl_set_id": ["fa4140e6-dc80-da99-e053-6294a90a194f"], "manufacturer_name": ["LABORATORIOS SOPHIA, S.A. DE C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (57619-304-01)  / 15 mL in 1 BOTTLE, PLASTIC", "package_ndc": "57619-304-01", "marketing_start_date": "20230425"}], "brand_name": "Splash Redness Reliever", "product_id": "57619-304_351e11b7-7c46-9bc7-e063-6294a90a46a7", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "57619-304", "generic_name": "Hypromellose, Naphazoline hydrochloride", "labeler_name": "LABORATORIOS SOPHIA, S.A. DE C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Splash Redness Reliever", "active_ingredients": [{"name": "HYPROMELLOSE 2910 (4000 MPA.S)", "strength": ".2 g/100mL"}, {"name": "NAPHAZOLINE HYDROCHLORIDE", "strength": ".02 g/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230425", "listing_expiration_date": "20261231"}