phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: hhh pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler hhh pharma usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 10 mg/1

Manufacturer
HHH PHARMA USA LLC

Identifiers & Regulatory

Product NDC 83586-010
Product ID 83586-010_3e763082-1ab4-0eeb-e063-6394a90af78b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83586010
Hyphenated Format 83586-010

Supplemental Identifiers

RxCUI
1049182
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 M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 130000 TABLET in 1 DRUM (83586-010-00)
source: ndc

Packages (1)

83586-010-00 130000 TABLET in 1 DRUM (83586-010-00)

Ingredients (1)

phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

PHENYLEPHRINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e763082-1ab4-0eeb-e063-6394a90af78b", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1049182"], "spl_set_id": ["5d8b980f-0011-41e3-a881-ad10fe399079"], "manufacturer_name": ["HHH PHARMA USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "130000 TABLET in 1 DRUM (83586-010-00)", "package_ndc": "83586-010-00", "marketing_start_date": "20250910"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "83586-010_3e763082-1ab4-0eeb-e063-6394a90af78b", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "83586-010", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "HHH PHARMA USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250910", "listing_expiration_date": "20261231"}