sinus pressure plus pain pe

Generic: acetaminophen and phenylephrine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sinus pressure plus pain pe
Generic Name acetaminophen and phenylephrine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-320
Product ID 36800-320_285fe11f-9255-5cbd-e063-6394a90a5afb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800320
Hyphenated Format 36800-320

Supplemental Identifiers

RxCUI
1046378
UPC
0036800386129
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 pressure plus pain pe (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 (36800-320-06) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

36800-320-06 2 BLISTER PACK in 1 CARTON (36800-320-06) / 12 TABLET, COATED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Sinus Pressure plus Pain PE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "285fe11f-9255-5cbd-e063-6394a90a5afb", "openfda": {"upc": ["0036800386129"], "unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["a9640e09-369c-3c55-e053-2a95a90aebd5"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (36800-320-06)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "36800-320-06", "marketing_start_date": "20210618"}], "brand_name": "Sinus Pressure plus Pain PE", "product_id": "36800-320_285fe11f-9255-5cbd-e063-6394a90a5afb", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "36800-320", "generic_name": "ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sinus Pressure plus Pain PE", "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": "20210618", "listing_expiration_date": "20261231"}