severe sinus congestion and pain

Generic: acetaminophen, guaifenesin, phenylephrine

Labeler: shield pharmaceuticals corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe sinus congestion and pain
Generic Name acetaminophen, guaifenesin, phenylephrine
Labeler shield pharmaceuticals corp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Shield Pharmaceuticals Corp

Identifiers & Regulatory

Product NDC 83059-0057
Product ID 83059-0057_4276cd88-1e20-408b-e063-6394a90ae904
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-10-30

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 830590057
Hyphenated Format 83059-0057

Supplemental Identifiers

RxCUI
1243679
UNII
362O9ITL9D 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 severe sinus congestion and pain (source: ndc)
Generic Name acetaminophen, guaifenesin, phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (83059-0057-1) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

83059-0057-1 1 BLISTER PACK in 1 CARTON (83059-0057-1) / 12 TABLET, COATED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Severe Sinus Congestion and Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4276cd88-1e20-408b-e063-6394a90ae904", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["c296efd0-5030-4a26-a9b0-e66423d995dc"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Shield Pharmaceuticals Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (83059-0057-1)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "83059-0057-1", "marketing_start_date": "20241030"}], "brand_name": "Severe Sinus Congestion and Pain", "product_id": "83059-0057_4276cd88-1e20-408b-e063-6394a90ae904", "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": "83059-0057", "generic_name": "Acetaminophen, Guaifenesin, Phenylephrine", "labeler_name": "Shield Pharmaceuticals Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Sinus Congestion and Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241030", "listing_expiration_date": "20261231"}