Splash Redness Reliever

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Splash Redness Reliever
Generic name: HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE
Manufacturer: LABORATORIOS SOPHIA, S.A. DE C.V.
Product type: HUMAN OTC DRUG
SPL set ID: fa4140e6-dc80-da99-e053-6294a90a194f
SPL ID: 351e11b7-7c46-9bc7-e063-6294a90a46a7
Version: 4
Effective date: 2025-05-09
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:27

Harmonized routes table
Harmonized routes
OPHTHALMIC

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M018	openfda.application_number
brand name		Splash Redness Reliever	openfda.brand_name
generic name		HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		LABORATORIOS SOPHIA, S.A. DE C.V.	openfda.manufacturer_name
ndc	package	57619-304-01	openfda.package_ndc
ndc	product	57619-304	openfda.product_ndc
ndc11	package	57619030401	derived:openfda.package_ndc
rxcui		2636530	openfda.rxcui
spl id		351e11b7-7c46-9bc7-e063-6294a90a46a7	id
spl set id		fa4140e6-dc80-da99-e053-6294a90a194f	set_id
unii		MZ1131787D	openfda.unii
unii		RN3152OP35	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use if solution changes color or becomes cloudy. When using this product do not touch tip of container to any surface to avoid contamination. replace cap after using. ask a doctor before use if you have narrow angle glaucoma. Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye condition worsens or persists for more than 72 hours. overuse may cause more redness of the eye pupil may become enlarged temporarily Keep out of reach of children. If swallowed, get medical help or contat a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.