sinus headache pemaximum strength non-drowsy maximum strength non-drowsy

Generic: acetaminophen and phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name sinus headache pemaximum strength non-drowsy maximum strength non-drowsy
Generic Name acetaminophen and phenylephrine hcl
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-270
Product ID 69168-270_5614edd7-fae9-4261-aa48-bd393f771caa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Marketing Start 2014-12-22
Marketing End 2027-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69168270
Hyphenated Format 69168-270

Supplemental Identifiers

RxCUI
1046378
UPC
0369168270954
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 headache pemaximum strength non-drowsy maximum strength non-drowsy (source: ndc)
Generic Name acetaminophen and phenylephrine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 18 TABLET in 1 BLISTER PACK (69168-270-95)
source: ndc

Packages (1)

69168-270-95 18 TABLET in 1 BLISTER PACK (69168-270-95)

Ingredients (2)

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

Linked Drug Pages (1)

Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5614edd7-fae9-4261-aa48-bd393f771caa", "openfda": {"upc": ["0369168270954"], "unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 TABLET in 1 BLISTER PACK (69168-270-95)", "package_ndc": "69168-270-95", "marketing_end_date": "20271031", "marketing_start_date": "20141222"}], "brand_name": "Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy", "product_id": "69168-270_5614edd7-fae9-4261-aa48-bd393f771caa", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69168-270", "generic_name": "Acetaminophen and Phenylephrine HCl", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sinus Headache PEMaximum Strength Non-Drowsy", "brand_name_suffix": "Maximum Strength Non-Drowsy", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20271031", "marketing_start_date": "20141222"}