cough and congestion

Generic: dextromethorphan hbr, guaifenesin

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cough and congestion
Generic Name dextromethorphan hbr, guaifenesin
Labeler cvs woonsocket prescription center, incorporated
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-500
Product ID 51316-500_dec599a2-aee8-429b-b5a9-05a7c5fb315f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-04-08

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 51316500
Hyphenated Format 51316-500

Supplemental Identifiers

RxCUI
1020138
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 cough and congestion (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 400 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (51316-500-19) / 237 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

51316-500-19 1 BOTTLE, PLASTIC in 1 CARTON (51316-500-19) / 237 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

Cough and Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dec599a2-aee8-429b-b5a9-05a7c5fb315f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["44fb27d3-5125-4511-84d2-76555bc46e66"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51316-500-19)  / 237 mL in 1 BOTTLE, PLASTIC", "package_ndc": "51316-500-19", "marketing_start_date": "20240408"}], "brand_name": "Cough and Congestion", "product_id": "51316-500_dec599a2-aee8-429b-b5a9-05a7c5fb315f", "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": "51316-500", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cough and Congestion", "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": "20240408", "listing_expiration_date": "20261231"}