Naphazoline HCI And Pheniramine Maleate

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: Naphazoline HCI And Pheniramine Maleate
Generic name: NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE
Manufacturer: Altaire Pharmaceuticals Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 5649c6e2-966f-44d9-b57e-5bb988eb373d
SPL ID: b78fd969-ee4c-0ea0-e053-2a95a90a480d
Version: 4
Effective date: 2020-12-28
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:44:02

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	078208	derived:openfda.application_number
application number		ANDA078208	openfda.application_number
brand name		Naphazoline HCI And Pheniramine Maleate	openfda.brand_name
generic name		NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE	openfda.generic_name
manufacturer name		Altaire Pharmaceuticals Inc.	openfda.manufacturer_name
ndc	package	59390-177-13	openfda.package_ndc
ndc	product	59390-177	openfda.product_ndc
ndc11	package	59390017713	derived:openfda.package_ndc
rxcui		1043704	openfda.rxcui
spl id		b78fd969-ee4c-0ea0-e053-2a95a90a480d	id
spl set id		5649c6e2-966f-44d9-b57e-5bb988eb373d	set_id
unii		NYW905655B	openfda.unii
unii		MZ1131787D	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: if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Do not use in children under 6 years of age unless directed by a physician. If this solution changes color or becomes cloudy, do not use. Overuse of this product may produce increased redness of the eye. If you are sensitive to any ingredient in this product, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

Reported adverse events (FAERS/openFDA)#

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