phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: invatech pharma solutions llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler invatech pharma solutions llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 10 mg/1

Manufacturer
InvaTech Pharma Solutions LLC

Identifiers & Regulatory

Product NDC 57631-018
Product ID 57631-018_4024f888-60d7-f820-e063-6394a90ab81d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-01-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57631018
Hyphenated Format 57631-018

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
  • 30000 TABLET in 1 DRUM (57631-018-00)
source: ndc

Packages (1)

57631-018-00 30000 TABLET in 1 DRUM (57631-018-00)

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": "4024f888-60d7-f820-e063-6394a90ab81d", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1049182"], "spl_set_id": ["b8d360fa-0d80-f6a8-e053-2a95a90a8bd4"], "manufacturer_name": ["InvaTech Pharma Solutions LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30000 TABLET in 1 DRUM (57631-018-00)", "package_ndc": "57631-018-00", "marketing_start_date": "20210113"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "57631-018_4024f888-60d7-f820-e063-6394a90ab81d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "57631-018", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "InvaTech Pharma Solutions 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": "20210113", "listing_expiration_date": "20261231"}