severe congestion and cough

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe congestion and cough
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler walgreen company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-6048
Product ID 0363-6048_031f54cf-3ac7-49b0-b8fd-b0a7a0975084
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-07-20

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 03636048
Hyphenated Format 0363-6048

Supplemental Identifiers

RxCUI
1372652
UPC
0311917008790
UNII
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 severe congestion and cough (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0363-6048-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0363-6048-19 2 BLISTER PACK in 1 CARTON (0363-6048-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Severe Congestion and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "031f54cf-3ac7-49b0-b8fd-b0a7a0975084", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0311917008790"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1372652"], "spl_set_id": ["1ddc04fb-069c-44fe-814b-ba4f503c4be0"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0363-6048-19)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0363-6048-19", "marketing_start_date": "20230718"}], "brand_name": "Severe Congestion and Cough", "product_id": "0363-6048_031f54cf-3ac7-49b0-b8fd-b0a7a0975084", "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": "0363-6048", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Congestion and Cough", "active_ingredients": [{"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": "20150720", "listing_expiration_date": "20261231"}