sinus plus headache

Generic: acetaminophen and phenylephrine hydrochloride

Labeler: topcare
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
TOPCARE

Identifiers & Regulatory

Product NDC 36800-322
Product ID 36800-322_285fc510-5d4e-7971-e063-6294a90aa966
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800322
Hyphenated Format 36800-322

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 plus 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 (36800-322-05) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

36800-322-05 2 BLISTER PACK in 1 CARTON (36800-322-05) / 12 TABLET, COATED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Sinus plus Headache ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "285fc510-5d4e-7971-e063-6294a90aa966", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["a1b2b16d-c767-2945-e053-2995a90a4834"], "manufacturer_name": ["TOPCARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (36800-322-05)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "36800-322-05", "marketing_start_date": "20200701"}], "brand_name": "Sinus plus Headache", "product_id": "36800-322_285fc510-5d4e-7971-e063-6294a90aa966", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "36800-322", "generic_name": "ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "TOPCARE", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sinus plus 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": "20200701", "listing_expiration_date": "20261231"}