pe sinus congestion

Generic: phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name pe sinus congestion
Generic Name phenylephrine hcl
Labeler topco associates, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 10 mg/1

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 36800-704
Product ID 36800-704_7f3d19c8-f2ae-44b1-932c-da72a3269088
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2022-03-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800704
Hyphenated Format 36800-704

Supplemental Identifiers

RxCUI
1049182
UPC
0036800118515
UNII
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 pe sinus congestion (source: ndc)
Generic Name phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (36800-704-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (36800-704-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BLISTER PACK in 1 CARTON (36800-704-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

36800-704-07 2 BLISTER PACK in 1 CARTON (36800-704-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK 36800-704-29 1 BOTTLE, PLASTIC in 1 CARTON (36800-704-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 36800-704-44 1 BLISTER PACK in 1 CARTON (36800-704-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

PE Sinus Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f3d19c8-f2ae-44b1-932c-da72a3269088", "openfda": {"upc": ["0036800118515"], "unii": ["04JA59TNSJ"], "rxcui": ["1049182"], "spl_set_id": ["3264e291-7a0f-4e25-8390-ba441f22f650"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (36800-704-07)  / 18 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "36800-704-07", "marketing_start_date": "20220315"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (36800-704-29)  / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-704-29", "marketing_start_date": "20220315"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (36800-704-44)  / 18 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "36800-704-44", "marketing_start_date": "20220315"}], "brand_name": "PE Sinus Congestion", "product_id": "36800-704_7f3d19c8-f2ae-44b1-932c-da72a3269088", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "36800-704", "generic_name": "Phenylephrine HCl", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PE Sinus Congestion", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220315", "listing_expiration_date": "20271231"}