sinus relief severe congestion and pain

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler: cardinal health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sinus relief severe congestion and pain
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Labeler cardinal health
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
CARDINAL HEALTH

Identifiers & Regulatory

Product NDC 70000-0080
Product ID 70000-0080_45ada5e4-1b7f-c75b-e063-6394a90ae3d4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2021-01-27
Marketing End 2028-02-28

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 700000080
Hyphenated Format 70000-0080

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 sinus relief severe congestion and pain (source: ndc)
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride (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
  • 2 BLISTER PACK in 1 CARTON (70000-0080-1) / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0080-1 2 BLISTER PACK in 1 CARTON (70000-0080-1) / 10 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)

Sinus Relief Severe Congestion and Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45ada5e4-1b7f-c75b-e063-6394a90ae3d4", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["645f8075-e33f-4e1a-9249-7368261cdcb9"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CARDINAL HEALTH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70000-0080-1)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "70000-0080-1", "marketing_end_date": "20280228", "marketing_start_date": "20210127"}], "brand_name": "Sinus Relief Severe Congestion and Pain", "product_id": "70000-0080_45ada5e4-1b7f-c75b-e063-6394a90ae3d4", "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": "70000-0080", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "CARDINAL HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sinus Relief Severe 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_end_date": "20280228", "marketing_start_date": "20210127"}