delsym cough plus chest congestion dm

Generic: dextromethorphan hydrobromide and guaifenesin

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name delsym cough plus chest congestion dm
Generic Name dextromethorphan hydrobromide and guaifenesin
Labeler rb health (us) llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-213
Product ID 63824-213_4b84f643-54e9-e188-e063-6294a90ac141
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2013-03-31

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 63824213
Hyphenated Format 63824-213

Supplemental Identifiers

RxCUI
1020138
UPC
0363824213668
UNII
9D2RTI9KYH 495W7451VQ
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 delsym cough plus chest congestion dm (source: ndc)
Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 400 mg/20mL
source: ndc
Packaging
  • 180 mL in 1 BOTTLE (63824-213-66)
source: ndc

Packages (1)

63824-213-66 180 mL in 1 BOTTLE (63824-213-66)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL)

Linked Drug Pages (1)

Delsym Cough Plus Chest Congestion DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b84f643-54e9-e188-e063-6294a90ac141", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824213668"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["8252cdec-b668-4450-b045-e093479ab542"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 mL in 1 BOTTLE (63824-213-66)", "package_ndc": "63824-213-66", "marketing_start_date": "20130331"}], "brand_name": "Delsym Cough Plus Chest Congestion DM", "product_id": "63824-213_4b84f643-54e9-e188-e063-6294a90ac141", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "63824-213", "generic_name": "Dextromethorphan Hydrobromide and Guaifenesin", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Delsym", "brand_name_suffix": "Cough Plus Chest Congestion DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130331", "listing_expiration_date": "20271231"}