MedPath

Phenylephrine Hydrochloride

These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10% safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%. PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% and 10%, for topical ophthalmic use Initial U.S. Approval: 1939

Approved
Approval ID

dcd09e27-93ec-463f-8062-a7dad96c4d0f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2023

Manufacturers
FDA

Bausch & Lomb Americas Inc.

DUNS: 118287629

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

phenylephrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82260-103
Application NumberNDA203510
Product Classification
M
Marketing Category
C73605
G
Generic Name
phenylephrine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 31, 2023
FDA Product Classification

INGREDIENTS (7)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT

phenylephrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82260-102
Application NumberNDA203510
Product Classification
M
Marketing Category
C73605
G
Generic Name
phenylephrine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 31, 2023
FDA Product Classification

INGREDIENTS (7)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Phenylephrine Hydrochloride - FDA Drug Approval Details