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

Manufacturer
Shield Pharmaceuticals Corp

Identifiers & Regulatory

Product NDC 83059-0106
Product ID 83059-0106_430968e1-e0ef-226a-e063-6294a90a4e21
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-11-07

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 830590106
Hyphenated Format 83059-0106

Supplemental Identifiers

RxCUI
1233575
UNII
362O9ITL9D TC2D6JAD40 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 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 BLISTER PACK in 1 CARTON (83059-0106-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

83059-0106-1 1 BLISTER PACK in 1 CARTON (83059-0106-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK

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": "430968e1-e0ef-226a-e063-6294a90a4e21", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1233575"], "spl_set_id": ["093649a4-f968-49bd-83af-bb7e0f448ecf"], "manufacturer_name": ["Shield Pharmaceuticals Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (83059-0106-1)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "83059-0106-1", "marketing_start_date": "20251107"}], "brand_name": "Allergy plus Sinus Headache", "product_id": "83059-0106_430968e1-e0ef-226a-e063-6294a90a4e21", "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": "83059-0106", "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": "20251107", "listing_expiration_date": "20261231"}