sedalmex xl flu (27854-350)

Drug Facts

Product Profile

Brand Name sedalmex xl flu

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler belmora llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 100 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer

Belmora LLC

Identifiers & Regulatory

Product NDC 27854-350

Product ID 27854-350_69c586ec-a04c-454f-9fd5-7f257b63125e

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2022-03-24

Pharmacologic Class

Established (EPC)

expectorant [epc]

Physiologic Effect

decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27854350

Hyphenated Format 27854-350

Supplemental Identifiers

RxCUI

1098435

UPC

0853030002755

UNII

362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ

NUI

N0000193956 N0000008867 N0000009560

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 sedalmex xl flu (source: ndc)

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1
100 mg/1
5 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (27854-350-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (1)

27854-350-01 2 BLISTER PACK in 1 CARTON (27854-350-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (100 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Sedalmex XL Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "69c586ec-a04c-454f-9fd5-7f257b63125e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0853030002755"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1098435"], "spl_set_id": ["f2edfedf-e06e-4d1b-8c2d-732e08ec113c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Belmora LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (27854-350-01)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "27854-350-01", "marketing_start_date": "20220324"}], "brand_name": "Sedalmex XL Flu", "product_id": "27854-350_69c586ec-a04c-454f-9fd5-7f257b63125e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "27854-350", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Belmora LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sedalmex XL Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "100 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220324", "listing_expiration_date": "20261231"}