phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 100 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0343
Product ID 0065-0343_c9ffa382-0391-4947-9638-dd7d648a6e38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207926
Listing Expiration 2026-12-31
Marketing Start 2015-01-15

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650343
Hyphenated Format 0065-0343

Supplemental Identifiers

RxCUI
1234571 1234579
UPC
0300650349048 0300650343022 0300650349055
UNII
04JA59TNSJ

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 phenylephrine hydrochloride (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number NDA207926 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

0065-0343-02 1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

phenylephrine hydrochloride (100 mg/mL)

Linked Drug Pages (1)

Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c9ffa382-0391-4947-9638-dd7d648a6e38", "openfda": {"upc": ["0300650349048", "0300650343022", "0300650349055"], "unii": ["04JA59TNSJ"], "rxcui": ["1234571", "1234579"], "spl_set_id": ["cacbb3fd-1c03-4523-a1bf-0ccc4be102ef"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-0343-02", "marketing_start_date": "20250430"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "0065-0343_c9ffa382-0391-4947-9638-dd7d648a6e38", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0065-0343", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "NDA207926", "marketing_category": "NDA", "marketing_start_date": "20150115", "listing_expiration_date": "20261231"}