pharbinex-pe

Generic: guaifenesin 400mg and phenylephrine hcl 10mg

Labeler: ulai health llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pharbinex-pe
Generic Name guaifenesin 400mg and phenylephrine hcl 10mg
Labeler ulai health llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Ulai Health LLC

Identifiers & Regulatory

Product NDC 73057-389
Product ID 73057-389_2c2a2804-8a2b-be5d-e063-6394a90a9763
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-07-18

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73057389
Hyphenated Format 73057-389

Supplemental Identifiers

RxCUI
1304111
UPC
0373057389047
UNII
495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 pharbinex-pe (source: ndc)
Generic Name guaifenesin 400mg and phenylephrine hcl 10mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04)
source: ndc

Packages (1)

73057-389-04 30 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04)

Ingredients (2)

guaifenesin (400 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Pharbinex-PE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c2a2804-8a2b-be5d-e063-6394a90a9763", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0373057389047"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["1304111"], "spl_set_id": ["e459bb83-b1d6-42fc-aa46-99ad117e6144"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Ulai Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04)", "package_ndc": "73057-389-04", "marketing_start_date": "20190718"}], "brand_name": "Pharbinex-PE", "product_id": "73057-389_2c2a2804-8a2b-be5d-e063-6394a90a9763", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "73057-389", "generic_name": "GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG", "labeler_name": "Ulai Health LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pharbinex-PE", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190718", "listing_expiration_date": "20261231"}