sinus and headache

Generic: acetaminophen and phenylephrine hcl

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sinus and headache
Generic Name acetaminophen and phenylephrine hcl
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Cardinal Health 110, LLC. DBA Leader

Identifiers & Regulatory

Product NDC 70000-0568
Product ID 70000-0568_098c6234-9eb4-4f51-a2d5-8f245ea23961
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2005-07-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000568
Hyphenated Format 70000-0568

Supplemental Identifiers

RxCUI
1046378
UPC
0096295139907
UNII
362O9ITL9D 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 sinus and headache (source: ndc)
Generic Name acetaminophen and phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (70000-0568-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0568-1 2 BLISTER PACK in 1 CARTON (70000-0568-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Sinus and Headache ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "098c6234-9eb4-4f51-a2d5-8f245ea23961", "openfda": {"upc": ["0096295139907"], "unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["3b8662bf-3abb-4e54-af9c-5fa1d2e19003"], "manufacturer_name": ["Cardinal Health 110, LLC. DBA Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70000-0568-1)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70000-0568-1", "marketing_start_date": "20050726"}], "brand_name": "Sinus and Headache", "product_id": "70000-0568_098c6234-9eb4-4f51-a2d5-8f245ea23961", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70000-0568", "generic_name": "Acetaminophen and Phenylephrine HCl", "labeler_name": "Cardinal Health 110, LLC. DBA Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sinus and Headache", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20050726", "listing_expiration_date": "20261231"}