FDA.reportPublic FDA data

Pi Yuan Chin

Manufacturer
International Nature Nutraceuticals | Zhejiang Dingtai Pharmaceutical Co., Ltd
Effective date
2025-12-27
Label type
HUMAN OTC DRUG LABEL
Version
33025
Source
full-release
Hydrated at
2026-06-01 01:28:56

Label at a glance#

ProductPi Yuan Chin
Active ingredientNAPHAZOLINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

For the temporary relief of nasal congestion due to the common cold.

Dosage and administration

1 or 2 drops in each nostril not more often than every 6 hours.  Do not give to children under 12 years of age unless directed by a doctor. 

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Naphazoline Hydrochloride: 0.05%

Purposes: Nasal Decongestant

Uses:

OTC - PURPOSE SECTION

For the temporary relief of nasal congestion due to the common cold.

Other information: 

INDICATIONS & USAGE SECTION

Do not use if safety seal on bottle or dropper tip is loose, broken or missing. Store in a cool dry place. 

Directions:

DOSAGE & ADMINISTRATION SECTION

1 or 2 drops in each nostril not more often than every 6 hours. 

Do not give to children under 12 years of age unless directed by a doctor. 

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Boric Acid, Sodium Borate, Disodium Edetate, Thimerosal, Purified Water

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51367-035-05Pi Yuan Chin1 in 1 BOTTLE, DROPPERSOLUTION/ DROPS133025

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787D3
NAPHAZOLINEACTIVE MOIETYH231GF11BV3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D43
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO3
THIMEROSALINACTIVE INGREDIENT2225PI3MOV3
WaterINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51367-03551367-035-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
EDETATE DISODIUM7FLD91C86KIACT
THIMEROSAL2225PI3MOVIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii+route
12 equally ranked IID candidates
THIMEROSALTHIMEROSAL2225PI3MOVSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+dosage form
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+dosage form
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+dosage form
12 equally ranked IID candidates
THIMEROSALTHIMEROSAL2225PI3MOVDROPS / NASAL0.01 mg/1mlExact identifier — unii+route
6 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii+route
12 equally ranked IID candidates
THIMEROSALTHIMEROSAL2225PI3MOVSOLUTION / NASAL0.01 mg/1mlExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
THIMEROSALTHIMEROSAL2225PI3MOVSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+dosage form
6 equally ranked IID candidates
THIMEROSALTHIMEROSAL2225PI3MOVDROPS / NASAL0.01 mg/1mlExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
THIMEROSALTHIMEROSAL2225PI3MOVSOLUTION / NASAL0.01 mg/1mlExact identifier — unii+route
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pi Yuan ChinNAPHAZOLINE HYDROCHLORIDEInternational Nature Nutraceuticalse7aedab9-da4c-4494-a896-1e6ed2a956fe2025-12-27WarningsExact identifier
ndc (package): 51367-035-05
ndc (product): 51367-035
ndc11 (package): 51367003505
spl id: e1a51940-cd56-4011-adc4-79c39c402cf1
spl set id: e7aedab9-da4c-4494-a896-1e6ed2a956fe

Reported adverse events (FAERS/openFDA)#

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