allergy plus sinus headache

Generic: acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg

Labeler: shield pharmaceuticals corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy plus sinus headache
Generic Name acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg
Labeler shield pharmaceuticals corp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, diphenhydramine hydrochloride 12.5 mg/1, phenylephrine hydrochloride 5 mg/1

Identifiers & Regulatory

Product NDC 83059-0044
Product ID 83059-0044_4b08cc8c-6caa-8ea8-e063-6294a90ae4bc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-09-02

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 830590044
Hyphenated Format 83059-0044

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 allergy plus sinus headache (source: ndc)
Generic Name acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 12.5 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 PACKAGE (83059-0044-1) / 15 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

83059-0044-1 1 BOTTLE in 1 PACKAGE (83059-0044-1) / 15 TABLET, FILM COATED in 1 BOTTLE

Ingredients (3)

acetaminophen (325 mg/1) diphenhydramine hydrochloride (12.5 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Allergy plus Sinus Headache ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b08cc8c-6caa-8ea8-e063-6294a90ae4bc", "openfda": {}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (83059-0044-1)  / 15 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "83059-0044-1", "marketing_start_date": "20240902"}], "brand_name": "Allergy plus Sinus Headache", "product_id": "83059-0044_4b08cc8c-6caa-8ea8-e063-6294a90ae4bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "83059-0044", "generic_name": "Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg", "labeler_name": "Shield Pharmaceuticals Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy plus Sinus Headache", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240902", "listing_expiration_date": "20261231"}