cough and congestion extended release (51316-065)

Drug Facts

Product Profile

Brand Name cough and congestion extended release

Generic Name guaifenesin and dextromethorphan hbr

Labeler cvs pharmacy, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 30 mg/1, guaifenesin 600 mg/1

Manufacturer

CVS Pharmacy, Inc.

Identifiers & Regulatory

Product NDC 51316-065

Product ID 51316-065_1bdf8077-f560-42b9-b59e-05579181d0b2

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA206941

Listing Expiration 2026-12-31

Marketing Start 2024-04-01

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 51316065

Hyphenated Format 51316-065

Supplemental Identifiers

RxCUI

1298324

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 extended release (source: ndc)

Generic Name guaifenesin and dextromethorphan hbr (source: ndc)

Application Number ANDA206941 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/1
600 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (51316-065-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

51316-065-67 2 BLISTER PACK in 1 CARTON (51316-065-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (30 mg/1) guaifenesin (600 mg/1)

Linked Drug Pages (1)

COUGH AND CONGESTION EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1bdf8077-f560-42b9-b59e-05579181d0b2", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["14254a0c-a843-6eec-e063-6394a90a72c5"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS Pharmacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-065-67)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-065-67", "marketing_start_date": "20240401"}], "brand_name": "COUGH AND CONGESTION EXTENDED RELEASE", "product_id": "51316-065_1bdf8077-f560-42b9-b59e-05579181d0b2", "dosage_form": "TABLET, EXTENDED RELEASE", "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": "51316-065", "generic_name": "Guaifenesin and Dextromethorphan HBr", "labeler_name": "CVS Pharmacy, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COUGH AND CONGESTION EXTENDED RELEASE", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA206941", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}