cough cold and sore throat childrens

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: walgreens
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cough cold and sore throat childrens
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler walgreens
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Walgreens

Identifiers & Regulatory

Product NDC 0363-4050
Product ID 0363-4050_5913a9bc-b821-42ea-977d-431691b1ebcf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

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 03634050
Hyphenated Format 0363-4050

Supplemental Identifiers

RxCUI
1116572
UPC
0311917168463
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 cough cold and sore throat childrens (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/10mL
  • 10 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0363-4050-04 1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

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

Linked Drug Pages (1)

Cough Cold and Sore Throat Childrens ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5913a9bc-b821-42ea-977d-431691b1ebcf", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0311917168463"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["400a0998-e276-4c8d-9b41-145b1b405fff"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Walgreens"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0363-4050-04", "marketing_start_date": "20141031"}], "brand_name": "Cough Cold and Sore Throat Childrens", "product_id": "0363-4050_5913a9bc-b821-42ea-977d-431691b1ebcf", "dosage_form": "LIQUID", "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": "0363-4050", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Walgreens", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cough Cold and Sore Throat", "brand_name_suffix": "Childrens", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}