sinus and headache

Generic: acetaminophen and phenylephrine hydrochloride

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sinus and headache
Generic Name acetaminophen and phenylephrine hydrochloride
Labeler amerisource bergen
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-658
Product ID 46122-658_2433ea4e-90e9-7b4d-e063-6394a90a0aae
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2020-10-15
Marketing End 2026-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122658
Hyphenated Format 46122-658

Supplemental Identifiers

RxCUI
1046378
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 hydrochloride (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 PACKAGE (46122-658-62) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

46122-658-62 2 BLISTER PACK in 1 PACKAGE (46122-658-62) / 12 TABLET, 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": "2433ea4e-90e9-7b4d-e063-6394a90a0aae", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["5347b46e-ddaa-42c0-ba25-75a4a542ae0f"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 PACKAGE (46122-658-62)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "46122-658-62", "marketing_end_date": "20260430", "marketing_start_date": "20201015"}], "brand_name": "Sinus and Headache", "product_id": "46122-658_2433ea4e-90e9-7b4d-e063-6394a90a0aae", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "46122-658", "generic_name": "ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "AMERISOURCE BERGEN", "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_end_date": "20260430", "marketing_start_date": "20201015"}