sinus and headache

Generic: acetaminophen and phenylephrine hydrochloride

Labeler: aaa pharmaceutical, inc.
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 aaa pharmaceutical, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
AAA Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 57344-923
Product ID 57344-923_284d5bbf-dd5e-99a2-e063-6394a90a3600
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57344923
Hyphenated Format 57344-923

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 CARTON (57344-923-05) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

57344-923-05 2 BLISTER PACK in 1 CARTON (57344-923-05) / 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": "284d5bbf-dd5e-99a2-e063-6394a90a3600", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["73d4fc82-8508-44f8-83ca-9f32c5cd847b"], "manufacturer_name": ["AAA Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (57344-923-05)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "57344-923-05", "marketing_start_date": "20200801"}], "brand_name": "Sinus and Headache", "product_id": "57344-923_284d5bbf-dd5e-99a2-e063-6394a90a3600", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "57344-923", "generic_name": "ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "AAA Pharmaceutical, Inc.", "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": "20200801", "listing_expiration_date": "20261231"}