mucus relief dm (51316-858)

Drug Facts

Product Profile

Brand Name mucus relief dm

Generic Name dextromethorphan hydrobromide, guaifenesin

Labeler cvs woonsocket prescription center, incorporated

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-858

Product ID 51316-858_4c81bfb6-4c87-464f-b2be-25fc365fe751

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA207602

Listing Expiration 2026-12-31

Marketing Start 2025-07-14

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 51316858

Hyphenated Format 51316-858

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 mucus relief dm (source: ndc)

Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)

Application Number ANDA207602 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 mg/1
600 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (51316-858-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

source: ndc

Packages (1)

51316-858-78 1 BOTTLE in 1 CARTON (51316-858-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

MUCUS RELIEF DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4c81bfb6-4c87-464f-b2be-25fc365fe751", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["db57f6b3-30ca-4a65-9043-f61be24d9b50"], "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 in 1 CARTON (51316-858-78)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "51316-858-78", "marketing_start_date": "20250714"}], "brand_name": "MUCUS RELIEF DM", "product_id": "51316-858_4c81bfb6-4c87-464f-b2be-25fc365fe751", "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": "51316-858", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MUCUS RELIEF DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA207602", "marketing_category": "ANDA", "marketing_start_date": "20250714", "listing_expiration_date": "20261231"}