cold and flu severe (50804-503)

Drug Facts

Product Profile

Brand Name cold and flu severe

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler geiss, destin & dunn inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer

Geiss, Destin & Dunn Inc.

Identifiers & Regulatory

Product NDC 50804-503

Product ID 50804-503_4067baa3-8e8d-4fab-af1d-df319151ad8c

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2020-06-09

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 50804503

Hyphenated Format 50804-503

Supplemental Identifiers

RxCUI

1110988

UPC

0846036009125

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 cold and flu severe (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
200 mg/1
5 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (50804-503-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (1)

50804-503-08 2 BLISTER PACK in 1 CARTON (50804-503-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cold and Flu Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4067baa3-8e8d-4fab-af1d-df319151ad8c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0846036009125"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1110988"], "spl_set_id": ["a7d2eaee-484e-43aa-8ae3-0e050219383f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Geiss, Destin & Dunn Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50804-503-08)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50804-503-08", "marketing_start_date": "20200609"}], "brand_name": "Cold and Flu Severe", "product_id": "50804-503_4067baa3-8e8d-4fab-af1d-df319151ad8c", "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": "50804-503", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Geiss, Destin & Dunn Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu", "brand_name_suffix": "Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200609", "listing_expiration_date": "20261231"}