cold, flu and sore throat (55319-705)

Drug Facts

Product Profile

Brand Name cold, flu and sore throat

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler family dollar services inc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer

Family Dollar Services Inc

Identifiers & Regulatory

Product NDC 55319-705

Product ID 55319-705_0f609300-f042-4c37-9ee7-663ee3e3d245

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2027-12-31

Marketing Start 2024-06-28

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 55319705

Hyphenated Format 55319-705

Supplemental Identifiers

RxCUI

1116572

UPC

0032251923814

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, flu and sore throat (source: ndc)

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

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

650 mg/20mL
20 mg/20mL
400 mg/20mL
10 mg/20mL

source: ndc

Packaging

177 mL in 1 BOTTLE, PLASTIC (55319-705-45)

source: ndc

Packages (1)

55319-705-45 177 mL in 1 BOTTLE, PLASTIC (55319-705-45)

Ingredients (4)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Cold, Flu and Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "0f609300-f042-4c37-9ee7-663ee3e3d245", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0032251923814"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["9ac649db-5083-427c-9637-1e2aecd2ca44"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Family Dollar Services Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (55319-705-45)", "package_ndc": "55319-705-45", "marketing_start_date": "20240628"}], "brand_name": "Cold, Flu and Sore Throat", "product_id": "55319-705_0f609300-f042-4c37-9ee7-663ee3e3d245", "dosage_form": "SOLUTION", "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": "55319-705", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Family Dollar Services Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold, Flu and Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240628", "listing_expiration_date": "20271231"}